Kidney/Renal Cancer

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A Phase II Proof of Principle Study of the Activity of Pembrolizumab (MK-3475) in Combination With SBRT in Primary Tyrosine Kinase Inhibitor (TKI) Refractory Metastatic Kidney Cancer (mRCC) Patients


Condition: Stage IV Renal Cell Cancer AJCC V7

Intervention:

  • Drug: Pembrolizumab
  • Radiation: Stereotactic Body Radiation Therapy

Purpose: This study is designed as a phase-II proof of concept trial to investigate if a treatment strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is sufficiently active to warrant further investigation in randomized phase II or III studies. Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more likely to have larger more aggressive tumours and reduced survival and renal tumours that express PD-L1 are more aggressive with poorer outcome. Blocking this receptor/ligand interaction with monoclonal antibodies can restore the activity of tumour specific T-cells within the tumour with durable responses documented in early clinical trials in several tumour types including renal cell carcinoma. The study drug pembrolizumab is designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be given to the 1-3 most clinically significant lesions at the time of progression on pembrolizumab or at the 2nd course of pembrolizumab treatment in an effort to improve the activity of pembrolizumab. A total of 35 patients refractory to the approved first line therapy with a targeted drug (Sunitinib or Pazopanib) or untreated RCC patients with sarcomatoid differentiation will be enrolled on study. This group of patient has a poor outcome on any other 2nd line therapy and urgently need novel therapy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02599779

Sponsor: Sunnybrook Health Sciences Centre

Primary Outcome Measures:

  • Measure: Progression-free survival, as per irRC, for pembrolizumab, given with SBRT in metastatic RCC patients where progression is the best response to their first line therapy with a TKI, and in untreated patients with sarcomatoid differentiation.
  • Time Frame: up to 36 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: Objective response rate by immune related response criteria (irRC), and RECIST 1.1 criteria
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
  • Time Frame: up to 36 months
  • Safety Issue:

Estimated Enrollment: 35

Study Start Date: December 2016

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  1. Be willing and able to provide written informed consent for the trial.
  2. Be ≥ 18 years of age on day of signing informed consent.
  3. Patients with a histologic confirmation of renal cell carcinoma with a clear cell component where the best response to first line TKI therapy (sunitinib, pazopanib, axitinib etc) is progression, or untreated RCC patients with sarcomatoid differentiation.
  4. Evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria. Patients should have an adequate number of non-irradiated metastatic sites in order to adequately assess the activity of the pembrolizumab therapy.
  5. Karnofsky performance status of ≥
  6. Favorable (0 risk factors), intermediate (1-2 risk factors) and poor risk (3-6 risk factors) patients by the Heng prognostic model are eligible based on the number of the following risk factors present.
  7. Demonstrate adequate organ function, all screening labs should be performed within 10 working days of the first dose of trial treatment.
  8. Male subjects should agree to use an adequate method of contraception starting with the first dose of trial treatment through 120 days after the last dose of trial treatment.
  9. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of trial treatment. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  10. One to three extra-cranial metastases eligible for SBRT.

Exclusion Criteria:

  • 1. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 2. Has had a prior monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 3. Has more than one previous targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  • Note: If subject received major surgery, they must have recovered adequately in the opinion of the investigator from the toxicity and/or complications from the intervention prior to starting trial treatment. 4. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 5. Has known brain metastases and/or carcinomatous meningitis. Exceptions include patients who have completed treatment for brain metastases at least 3 months prior to starting treatment with pembrolizumab and remained stable and no longer require steroids to control brain edema. 6. Diagnosis of ataxia telangiectasia or active collagen vascular disease. 7. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. 8. Has evidence of interstitial lung disease, a history of non-infectious pneumonitis that required steroids, or current pneumonitis. 9. Has a known active infection requiring systemic therapy. 10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 12. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. 13. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). 14. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 15. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). 16. Has received a live vaccine within 30 days prior to the first dose of trial treatment.

Contact:

  • Georg Bjarnason, MD
  • 416-480-5847

Locations:

  • Tom Baker Cancer Centre
  • Calgary Alberta T2N 4N2 Canada
  • Sunnybrook Health Sciences Centre
  • Toronto Ontario M4N 3M5 Canada
  • Princess Margaret Hospital
  • Toronto Ontario M5G 2M9 Canada

View trial on ClinicalTrials.gov


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A Phase I/IB Study of Avelumab in Combination With Gemcitabine for Advanced Renal Cell Carcinoma With Sarcomatoid Differentiation


Condition: Metastatic sRCC

Intervention:

  • Drug: Avelumab
  • Drug: Gemcitabine

Purpose: To determine the feasibility and safety of avelumab and gemcitabine combination therapy in patients with metastatic sRCC.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03483883

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Primary Outcome Measures:

  • Measure: Number of Adverse Events
  • Time Frame: 36 months
  • Safety Issue:

Estimated Enrollment: 24

Study Start Date: March 19, 2018

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histologic evidence of metastatic RCC with sarcomatoid features (≥10% sarcomatoid component) or poor-risk RCC prognostic features (as defined by IMDC criteria). (14) An outside pathology report is sufficient for study eligibility. However, pathology should still be obtained as possible for internal institutional pathology review.
  • ≥ 18 years of age.
  • Phase I dose-escalation portion only: Patients must have ≤3 prior systemic treatment regimens with recent evidence of disease progression by RECIST 1.1 criteria. Previous treatment with immune-checkpoint inhibitor therapy is allowable as a line of systemic therapy for the phase I portion. Prior systemic therapy in the adjuvant treatment setting is allowable as a prior line of therapy. Phase Ib dose-expansion portion only: Patients must have been treated with 0 or 1 prior lines of systemic therapy. Previous treatment with immune-checkpoint inhibitor therapy is allowable as a line of systemic therapy for the phase Ib expansion portion.
  • No prior therapy with gemcitabine chemotherapy.
  • ECOG performance status of 0-1. Patients must have primary or metastatic FFPE tissue available for histologic confirmation and possible determination of percent sarcomatoid component (if applicable). Outside pathology report is sufficient for study eligibility. However, pathology should still be obtained as possible for internal institutional pathology review.
  • Patients with history of treated brain metastases are eligible if off systemic corticosteroids for at least 2 weeks.
  • Patients must have normal organ function, as confirmed by laboratory values obtained ≤ 14 days prior to the first day of study therapy: Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused) Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver). Renal: Estimated creatinine clearance ≥ 45 mL/min using Cockroft Gault formula.
  • Patients must have a projected life expectancy of at least 3 months.
  • PREGNANCY AND CONTRACEPTION: Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists. In addition, women must not breastfeed while on this study as study drugs may also affect a breast-feeding child. Pregnant women and women who are breastfeeding are not allowed to participate in this study.

Exclusion Criteria:

  • IMMUNOSUPRESSANTS: Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
  • ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell transplantation.
  • INFECTIONS: Active infection requiring systemic therapy.
  • HIV/AIDS: Known history of testing positive for HIV or known acquired immunodeficiency syndrome, or positive HIV test result at screening.
  • HEPATITIS: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
  • VACCINATION: Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
  • HYPERSENSITIIVTY TO STUDY DRUG: Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
  • CARDIOVASCULAR DISEASE: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
  • OTHER PERSISTING TOXICITIES: Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
  • Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Contact:

  • Vivek Narayan, MD
  • 855-216-0098

Location:

  • Abramson Cancer Center of the University of Pennsylvania
  • Philadelphia Pennsylvania 19104 United States

View trial on ClinicalTrials.gov


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Phase II Trial of Nivolumab and Stereotactic Ablative Radiation Therapy (SAbR) for Metastatic Clear Cell Renal Cell Carcinoma (mRCC)


Condition: Metastatic Clear Cell Renal Cell Carcinoma

Intervention:

  • Drug: Nivolumab
  • Radiation: SAbR

Purpose: Nivolumab (brand name Opdivo): IV, 3 mg/kg q2 weeks, until disease progression or unacceptable toxicity; SABR, dose variable, in 1-3 fractions.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02781506

Sponsor: University of Texas Southwestern Medical Center

Primary Outcome Measures:

  • Measure: Response Rate (RR)
  • Time Frame: 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Progression free survival
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Complete response rate
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Time to progression
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Median response duration
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Toxicity
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Health-related quality of life
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: immunogenicity
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Immunological biomarkers
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Cost-effectiveness
  • Time Frame: 5 years
  • Safety Issue:

Estimated Enrollment: 35

Study Start Date: June 20, 2016

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: All

Inclusion Criteria:

  • At least 18 years of age
  • Willing and able to provide consent
  • Pathologic diagnosis of metastatic RCC with clear cell component
  • Measurable disease in at least 2 non-radiated sites. Progression or intolerance to at least one prior systemic anti-angiogenic therapy.
  • Eligible for extra-CNS SAbR to 1-6 sites of disease
  • Must have received at least one prior anti-angiogenic therapy in the advanced or metastatic setting. Prior cytokine therapy (eg, IL-2, IFN-α), vaccine therapy, or treatment with cytotoxic therapy is also allowed but not any other drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Previous treatment with surgery, radiation, chemotherapy, targeted agents (see above) are allowed provided that: Chemotherapy/Major surgery was administered > 14 days before the start Nivolumab; Minor surgery, radiation, or any targeted agents were administered > 7 days before the start of Nivolumab
  • Performance status ECOG 0, 1, 2 or 3.
  • Adequate organ and marrow function as defined below (obtained within 14 days of first dose of drug):
  • leukocytes≥ 2,000/mcL
  • absolute neutrophil count ≥ 1,500/mcL
  • platelets ≥ 50,000/mcl
  • total bilirubin ≤ 2mg/dL
  • AST(SGOT)/ALT(SPGT) ≤ 3 X institutional upper limit of normal
  • Women of child-bearing potential
  • female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product.
  • Women must not be breastfeeding.
  • must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half lives.
  • Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half lives. This is equivalent to 31 weeks after discontinuation of Nivolumab.
  • Adequate Renal function with Cr ≤ 2.5 mg/dL.

Exclusion Criteria:

  • Subjects who have had major surgery (such as nephrectomy) or chemotherapy within 2 weeks prior to first dose of drug
  • Subjects who have had radiation therapy within 2 weeks prior to first dose of drug
  • Uncontrolled adrenal insufficiency or active chronic liver disease
  • Any history of CNS metastases that is not adequately treated with surgery or SABR >14 days prior.
  • Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Any positive history for HIV/AIDS, HTLV, hepatitis B or hepatitis C virus indicating acute or chronic infection.
  • Any active known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalent are permitted (although not encouraged) in the absence of active autoimmune disease.
  • Subjects with life expectancy < 6 months
  • Subjects receiving any other investigational or standard antineoplastic agents.
  • Prior malignancies active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, breast?, or etc.
  • Psychiatric illness/social situations that would limit consenting and compliance with study requirements.
  • Patients with history of hypersensitivity to monoclonal antibodies
  • Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants

Contact:

  • Raquibu Hannan, MD, PhD
  • 214-645-8525

Location:

  • University of Texas Southwestern Medical Center
  • Dallas Texas 75390 United States

View trial on ClinicalTrials.gov


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Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)


Condition: Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer

Intervention:

  • Drug: Enzalutamide
  • Other: Laboratory Biomarker Analysis
  • Procedure: Nephrectomy

Purpose: This pilot phase 0 trial studies how well enzalutamide works before surgery in treating patients with kidney cancer. Androgens are a type of hormone produced by the body that may cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the amount of androgens produced by the body and keep kidney tumors from growing.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02885649

Sponsor: Rutgers, The State University of New Jersey

Primary Outcome Measures:

  • Measure: Cell proliferation
  • Time Frame: Up to 36 months
  • Safety Issue:
  • Measure: Tumor apoptosis as measured by annexin
  • Time Frame: Up to 36 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4
  • Time Frame: Up to 36 months
  • Safety Issue:
  • Measure: Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Time Frame: Up to 36 months
  • Safety Issue:

Estimated Enrollment: 20

Study Start Date: December 5, 2017

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Clinical T1N0M0 (=< 7 cm) renal mass as measured on cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
  • Biopsy proven ccRCC
  • Tumor with androgen receptor (AR) expressed >= 4580 copies/ug ribonucleic acid (RNA)
  • Can provide informed consent
  • Adequate hepatic function (>= 1.5 x upper limit of normal [ULN]; patient's with Gilbert's disease are not excluded)
  • Adequate renal function (estimated glomerular filtration rate [GFR] > 40mL/min)
  • No evidence of metastatic disease on baseline imaging (chest x-ray [CXR] or chest CT, abdominal CT or MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Exclusion Criteria:

  • Prior use of androgen deprivation including enzalutamide
  • Pregnant women or women who are of child bearing age who are not willing to use two (2) forms of contraception during treatment with enzalutamide and for six (6) months after treatment
  • Men must use adequate methods of contraception during and at least 3 months after treatment if engaging in sexual activity with a female of child bearing age
  • Known hypersensitivity to enzalutamide
  • History of unprovoked deep vein thrombosis/pulmonary embolism (DVT/PE) in past twelve (12) months
  • Inability to stop anticoagulants/antiplatelet therapy peri-operatively
  • History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma)
  • History of loss of consciousness or transient ischemic attack within twelve (12) months of enrollment
  • Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within twelve (12) months prior to screening
  • Known or suspected brain metastasis or active leptomeningeal disease
  • Current use of exogenous testosterone
  • Retroperitoneal/hilar adenopathy concerning for locally advanced disease
  • Metastatic RCC

Location:

  • Rutgers Cancer Institute of New Jersey
  • New Brunswick New Jersey 08903 United States

View trial on ClinicalTrials.gov


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A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) in Patients With Advanced Renal Cell Carcinoma in Second or Third Line Setting in Real Life


Condition: Renal Cell Carcinoma, Renal Cell Cancer, Adenocarcinoma Of Kidney, Adenocarcinoma, Renal Cell, Kidney Cancer, Cancer of the Kidney

Intervention:

  • Other: Non-interventional

Purpose: This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with renal cell carcinoma, who start a new systemic therapy with nivolumab for the first time and within the market authorization approval, following a first or second-line therapy.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03455452

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: Overall Survival (OS)
  • Time Frame: up to 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression Free Survival (PFS)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Overall Response Rate (ORR)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Best Overall Response Rate (BORR)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Best Overall Response (BOR)
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Distribution of socio-demographic characteristics in adult patients with advanced Renal Cell Carcinoma (RCC)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Distribution of clinical characteristics in adult patients with advanced Renal Cell Carcinoma (RCC)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Distribution of treatment patterns in adult patients with advanced Renal Cell Carcinoma (RCC)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Distribution of management of treatment-related Adverse Events (AE)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Memorial Sloan Kettering Cancer Center (MSKCC) score
  • Time Frame: At baseline
  • Safety Issue:
  • Measure: International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score
  • Time Frame: At baseline
  • Safety Issue:
  • Measure: Distribution of incidence of treatment-related Adverse Events (AE)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Distribution of severity of treatment-related Adverse Events (AE)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Quality of Life (QoL) scores (EQ-5D utility)
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Quality of Life (QoL) scores (FKSI-19)
  • Time Frame: Approximately 3 years
  • Safety Issue:

Estimated Enrollment: 323

Study Start Date: January 12, 2018

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Adult patients with the diagnosis of advanced RCC (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab as second or third line therapy for the first time for the treatment of RCC, according to the label approved in France Exclusion Criteria:
  • Patients with a primary diagnosis of a cancer other than advanced RCC within the past five years, ie, a cancer other than RCC that requires systemic or other treatment
  • Patients previously treated with anti-PD1, anti-PDL1 or anti-CTLA4 therapy
  • Patients currently included in an interventional clinical trial for their advanced or RCC. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled Other protocol defined inclusion/

Exclusion Criteria:

  • Patients with a primary diagnosis of a cancer other than advanced RCC within the past five years, ie, a cancer other than RCC that requires systemic or other treatment
  • Patients previously treated with anti-PD1, anti-PDL1 or anti-CTLA4 therapy
  • Patients currently included in an interventional clinical trial for their advanced or RCC. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled Other protocol defined inclusion/exclusion criteria could apply

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
  • please email:

Locations:

  • Local Institution
  • Paris 75002 France
  • Local Institution
  • Paris 75002 France

View trial on ClinicalTrials.gov


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A Phase I/II Trial of Pazopanib Alternating With Bevacizumab in Treatment-Naive Metastatic Clear Cell Renal Cell Carcinoma Patients


Condition: Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer

Intervention:

  • Biological: Bevacizumab
  • Other: Laboratory Biomarker Analysis
  • Drug: Pazopanib Hydrochloride
  • Other: Pharmacological Study

Purpose: This phase I/II trial studies the side effects and best dose of pazopanib hydrochloride and bevacizumab and to see how well they work in treating patients with previously untreated kidney cancer that has spread to other places in the body (metastatic). Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of tumor cells by blocking blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can prevent tumor growth by blocking the ability of tumor cells to grow and spread. Giving pazopanib hydrochloride together with bevacizumab may kill more tumor cells.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01684397

Sponsor: Roswell Park Cancer Institute

Primary Outcome Measures:

  • Measure: Median PFS (Phase II)
  • Time Frame: Up to 30 days post-treatment
  • Safety Issue:
  • Measure: Optimal phase II dose, defined as the largest dose level at which less than 2 out of the 6 patients experienced dose-limiting toxicity, graded according to Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
  • Time Frame: Up to 140 days
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Incidence of grade 3 or higher toxicities, graded according to CTCAE version 4.0
  • Time Frame: Up to 30 days post-treatment
  • Safety Issue:
  • Measure: Overall survival (Phase II)
  • Time Frame: From the date of study enrollment to the date of death from any cause, assessed up to 30 days post-treatment
  • Safety Issue:
  • Measure: PFS rate at 12 months (Phase II)
  • Time Frame: At 12 months
  • Safety Issue:
  • Measure: Response rate according to RECIST 1.1 (Phase I)
  • Time Frame: Up to 30 days post-treatment
  • Safety Issue:

Estimated Enrollment: 35

Study Start Date: October 5, 2012

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Biopsy/pathology-proven clear cell renal cell carcinoma (CCRCC) with metastases
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Hemoglobin >= 10 gm/dL
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Total bilirubin =< upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< ULN
  • International normalization ratio (INR) and activated partial thromboplastin time (aPTT) < 1.2 x ULN
  • Serum creatinine < 1.5 mg/dL or if serum creatinine > 1.5 mg/dL then calculate creatinine clearance (CrCL) > 30 mL/min
  • Urine protein to creatinine ratio =< 1 (if urine protein creatinine ratio is > 1, then a 24-hour urine total protein must be assessed; subjects will be ineligible if the 24-hour urine protein is found to be > 1 gm)
  • Normal cardiac ejection fraction (> 50%) by multi gated acquisition scan (MUGA) or echocardiogram
  • Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
  • Ability to swallow and retain oral medication
  • Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Subjects with known brain metastases should be excluded from this clinical trial
  • Prior VEGF targeted therapies for renal cell carcinoma (RCC) including adjuvant or neoadjuvant treatments; in phase 1 only, one prior therapy with high dose IL-2 or anti-programmed cell death (PD)-1 compound alone or in combination with cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) targeting drug is allowed on the trial
  • Subjects diagnosed with another cancer in the past 3 years; excluding basal cell carcinoma or squamous cell carcinoma, of skin which were completely cured by resection
  • Concurrent use of another anti-cancer drug including an investigational anti-cancer agent
  • Major surgery within 28 days prior to treatment or major surgery planned during the next 6 months
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic or psychiatric illness/social situations that would limit compliance with study requirements
  • History of any of the following cardio-vascular condition:
  • Myocardial infarction (MI)
  • Unstable angina
  • Coronary artery bypass grafting (CABG)
  • Coronary angioplasty or stenting
  • Symptomatic peripheral arterial disease (PAD)
  • History of symptomatic chronic congestive heart failure (CHF)
  • History of cerebrovascular accidents including transient ischemic attacks (TIA)
  • Corrected QT interval (QTc) > 480 msec
  • Uncontrolled hypertension (systolic blood pressure [BP] > 150 mm Hg or diastolic BP of > 90 mm Hg); if the screening BP is elevated, adjustments in anti-hypertensives are permitted and a re-screening will be permitted for BP assessment with three consecutive values obtained 2 minutes apart; the 3 values have to be below 150/90 mm Hg for eligibility and can only be obtained after 2 days of the last change in anti-hypertensive medication; use of clonidine is not permissible for adjusting the BP during this period
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 6 months
  • Subjects should not have packed red blood cells (PRBC) or platelet transfusion within 14 days of the screening
  • Evidence of active bleeding or bleeding disorder
  • Subjects currently on anti-coagulation therapy are not eligible
  • Unable to discontinue the use of prohibited medications
  • Pregnant or nursing female subjects
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
  • Received an investigational agent within 30 days prior to enrollment

Locations:

  • Karamanos Cancer Institute
  • Detroit Michigan 482018 United States
  • Roswell Park Cancer Institute
  • Buffalo New York 14263 United States
  • University of Pittsburgh Cancer Institute (UPCI)
  • Pittsburgh Pennsylvania 15232 United States
  • Medical College of Wisconsin
  • Milwaukee Wisconsin 53226 United States

View trial on ClinicalTrials.gov


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Renal Tumors Classification, Biology, and Banking Study


Condition: Clear Cell Sarcoma of the Kidney, Congenital Mesoblastic Nephroma, Diffuse Hyperplastic Perilobar Nephroblastomatosis, Rhabdoid Tumor of the Kidney, Stage I Kidney Wilms Tumor, Stage I Renal Cell Cancer AJCC v6 and v7, Stage II Kidney Wilms Tumor, Stage II Renal Cell Cancer AJCC v7, Stage III Kidney Wilms Tumor, Stage III Renal Cell Cancer AJCC v7, Stage IV Kidney Wilms Tumor, Stage IV Renal Cell Cancer AJCC v7, Stage V Kidney Wilms Tumor

Intervention:

  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis

Purpose: This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00898365

Sponsor: Children's Oncology Group

Primary Outcome Measures:

  • Measure: Disease-free survival
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: Up to 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Loss of heterozygosity (LOH testing discontinued as of April 2014)
  • Time Frame: Up to 5 years
  • Safety Issue:

Estimated Enrollment: 5000

Study Start Date: February 27, 2006

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Eligibility:

  • Age: minimum N/A maximum 29 Years
  • Gender: All

Inclusion Criteria:

  • Patients with the first occurrence of any tumor of the kidney identified on CT scan or MRI are eligible for this study; histologic diagnosis is not required prior to enrollment but is required for all patients once on study
  • Eligible tumors include (but are not limited to):
  • Nephroblastic tumors
  • Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse, focal])
  • Nephrogenic rests and nephroblastomatosis
  • Cystic nephroma and cystic partially differentiated nephroblastoma
  • Metanephric tumors (metanephric adenoma, metanephric adenofibroma, metanephric stromal tumor)
  • Mesoblastic nephroma (cellular, classic, mixed)
  • Clear cell sarcoma
  • Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the central nervous system [CNS])
  • Renal epithelioid tumors of childhood (papillary renal cell carcinoma, medullary renal cell carcinoma, renal tumors associated with Xp11.2 translocations, oncocytic renal neoplasms after neuroblastoma)
  • Angiolipoma
  • Ossifying renal tumor of infancy
  • Patients with the first occurrence of the following tumors are also eligible:
  • Extrarenal nephroblastoma or extrarenal neprogenic rests
  • Malignant rhabdoid tumor occurring anywhere outside the Central Nervous System
  • Required specimens, reports, and copies of imaging studies must be available for submission or must become available during the required timeframe
  • For ALL patients (with exception of bilateral, bilaterally predisposed or unilateral tumor in solitary kidney planning to enroll without biopsy), the following submissions are required:
  • A complete set of recut hematoxylin and eosin (H & E) slides**
  • Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor**
  • Institutional pathology report, transmittal form and pathology checklist
  • Copies of images and institutional reports of CT and/or MRI abdomen and pelvis
  • Copies of images and institutional report of CT chest for all malignant tumors
  • Institutional surgical report(s)
  • Tissue must be from diagnosis, prior to any chemotherapy or radiation
  • For patients with clinical features and required imaging findings consistent with the eligibility for the bilateral study, AREN0534 (or successor study), confirmed by central review, biopsy is not required; however, if biopsy is done, tissue must be submitted as for other renal tumors, and initial risk assignment will require pathology and surgical rapid central reviews; transmittal form and pathology checklist are also needed
  • Patients with extrarenal Wilms tumor must have tumor tissue available for central review
  • Patients with extra-CNS malignant rhabdoid tumor must have tumor tissue available for central review
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Locations:

  • Children's Hospital of Alabama
  • Birmingham Alabama 35233 United States
  • University of Alabama at Birmingham Cancer Center
  • Birmingham Alabama 35233 United States
  • USA Health Strada Patient Care Center
  • Mobile Alabama 36604 United States
  • Providence Alaska Medical Center
  • Anchorage Alaska 99508 United States
  • Phoenix Childrens Hospital
  • Phoenix Arizona 85016 United States
  • The University of Arizona Medical Center-University Campus
  • Tucson Arizona 85724 United States
  • Arkansas Children's Hospital
  • Little Rock Arkansas 72202-3591 United States
  • University of Arkansas for Medical Sciences
  • Little Rock Arkansas 72205 United States
  • Kaiser Permanente Downey Medical Center
  • Downey California 90242 United States
  • City of Hope Comprehensive Cancer Center
  • Duarte California 91010 United States
  • Loma Linda University Medical Center
  • Loma Linda California 92354 United States
  • Miller Children's and Women's Hospital Long Beach
  • Long Beach California 90806 United States
  • Children's Hospital Los Angeles
  • Los Angeles California 90027 United States
  • Cedars Sinai Medical Center
  • Los Angeles California 90048 United States
  • Mattel Children's Hospital UCLA
  • Los Angeles California 90095 United States
  • Valley Children's Hospital
  • Madera California 93636 United States
  • Children's Hospital and Research Center at Oakland
  • Oakland California 94609-1809 United States
  • Kaiser Permanente-Oakland
  • Oakland California 94611 United States
  • Children's Hospital of Orange County
  • Orange California 92868 United States
  • Lucile Packard Children's Hospital Stanford University
  • Palo Alto California 94304 United States
  • Sutter Medical Center Sacramento
  • Sacramento California 95816 United States
  • University of California Davis Comprehensive Cancer Center
  • Sacramento California 95817 United States
  • Rady Children's Hospital - San Diego
  • San Diego California 92123 United States
  • Naval Medical Center -San Diego
  • San Diego California 92134 United States
  • UCSF Medical Center-Parnassus
  • San Francisco California 94143 United States
  • UCSF Medical Center-Mission Bay
  • San Francisco California 94158 United States
  • Santa Barbara Cottage Hospital
  • Santa Barbara California 93102 United States
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  • Torrance California 90502 United States
  • Children's Hospital Colorado
  • Aurora Colorado 80045 United States
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
  • Denver Colorado 80218 United States
  • Connecticut Children's Medical Center
  • Hartford Connecticut 06106 United States
  • Yale University
  • New Haven Connecticut 06520 United States
  • Alfred I duPont Hospital for Children
  • Wilmington Delaware 19803 United States
  • MedStar Georgetown University Hospital
  • Washington District of Columbia 20007 United States
  • Children's National Medical Center
  • Washington District of Columbia 20010 United States
  • Broward Health Medical Center
  • Fort Lauderdale Florida 33316 United States
  • Lee Memorial Health System
  • Fort Myers Florida 33901 United States
  • Golisano Children's Hospital of Southwest Florida
  • Fort Myers Florida 33908 United States
  • University of Florida Health Science Center - Gainesville
  • Gainesville Florida 32610 United States
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
  • Hollywood Florida 33021 United States
  • Nemours Children's Clinic-Jacksonville
  • Jacksonville Florida 32207 United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Miami Florida 33136 United States
  • Nicklaus Children's Hospital
  • Miami Florida 33155 United States
  • Miami Cancer Institute
  • Miami Florida 33176 United States
  • Florida Hospital Orlando
  • Orlando Florida 32803 United States
  • Arnold Palmer Hospital for Children
  • Orlando Florida 32806 United States
  • Nemours Children's Clinic - Orlando
  • Orlando Florida 32806 United States
  • UF Cancer Center at Orlando Health
  • Orlando Florida 32806 United States
  • Nemours Children's Hospital
  • Orlando Florida 32827 United States
  • Nemours Children's Clinic - Pensacola
  • Pensacola Florida 32504 United States
  • Johns Hopkins All Children's Hospital
  • Saint Petersburg Florida 33701 United States
  • Tampa General Hospital
  • Tampa Florida 33606 United States
  • Saint Joseph's Hospital/Children's Hospital-Tampa
  • Tampa Florida 33607 United States
  • Saint Mary's Hospital
  • West Palm Beach Florida 33407 United States
  • Children's Healthcare of Atlanta - Egleston
  • Atlanta Georgia 30322 United States
  • Augusta University Medical Center
  • Augusta Georgia 30912 United States
  • Memorial Health University Medical Center
  • Savannah Georgia 31404 United States
  • University of Hawaii Cancer Center
  • Honolulu Hawaii 96813 United States
  • Kapiolani Medical Center for Women and Children
  • Honolulu Hawaii 96826 United States
  • Tripler Army Medical Center
  • Honolulu Hawaii 96859 United States
  • Saint Luke's Mountain States Tumor Institute
  • Boise Idaho 83712 United States
  • Lurie Children's Hospital-Chicago
  • Chicago Illinois 60611 United States
  • University of Illinois
  • Chicago Illinois 60612 United States
  • University of Chicago Comprehensive Cancer Center
  • Chicago Illinois 60637 United States
  • Loyola University Medical Center
  • Maywood Illinois 60153 United States
  • Advocate Children's Hospital-Oak Lawn
  • Oak Lawn Illinois 60453 United States
  • Advocate Children's Hospital-Park Ridge
  • Park Ridge Illinois 60068 United States
  • Advocate Lutheran General Hospital
  • Park Ridge Illinois 60068 United States
  • Saint Jude Midwest Affiliate
  • Peoria Illinois 61637 United States
  • Southern Illinois University School of Medicine
  • Springfield Illinois 62702 United States
  • Riley Hospital for Children
  • Indianapolis Indiana 46202 United States
  • Saint Vincent Hospital and Health Care Center
  • Indianapolis Indiana 46260 United States
  • Blank Children's Hospital
  • Des Moines Iowa 50309 United States
  • University of Iowa/Holden Comprehensive Cancer Center
  • Iowa City Iowa 52242 United States
  • University of Kansas Cancer Center
  • Kansas City Kansas 66160 United States
  • University of Kentucky/Markey Cancer Center
  • Lexington Kentucky 40536 United States
  • Norton Children's Hospital
  • Louisville Kentucky 40202 United States
  • Tulane University Health Sciences Center
  • New Orleans Louisiana 70112 United States
  • Children's Hospital New Orleans
  • New Orleans Louisiana 70118 United States
  • Ochsner Medical Center Jefferson
  • New Orleans Louisiana 70121 United States
  • Eastern Maine Medical Center
  • Bangor Maine 04401 United States
  • Maine Children's Cancer Program
  • Scarborough Maine 04074 United States
  • University of Maryland/Greenebaum Cancer Center
  • Baltimore Maryland 21201 United States
  • Sinai Hospital of Baltimore
  • Baltimore Maryland 21215 United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Baltimore Maryland 21287 United States
  • Walter Reed National Military Medical Center
  • Bethesda Maryland 20889-5600 United States
  • Floating Hospital for Children at Tufts Medical Center
  • Boston Massachusetts 02111 United States
  • Massachusetts General Hospital Cancer Center
  • Boston Massachusetts 02114 United States
  • Dana-Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Baystate Medical Center
  • Springfield Massachusetts 01199 United States
  • University of Massachusetts Medical School
  • Worcester Massachusetts 01655 United States
  • C S Mott Children's Hospital
  • Ann Arbor Michigan 48109 United States
  • Wayne State University/Karmanos Cancer Institute
  • Detroit Michigan 48201 United States
  • Ascension Saint John Hospital
  • Detroit Michigan 48236 United States
  • Michigan State University Clinical Center
  • East Lansing Michigan 48824-7016 United States
  • Hurley Medical Center
  • Flint Michigan 48503 United States
  • Helen DeVos Children's Hospital at Spectrum Health
  • Grand Rapids Michigan 49503 United States
  • Bronson Methodist Hospital
  • Kalamazoo Michigan 49007 United States
  • Kalamazoo Center for Medical Studies
  • Kalamazoo Michigan 49008 United States
  • Beaumont Children's Hospital-Royal Oak
  • Royal Oak Michigan 48073 United States
  • William Beaumont Hospital-Royal Oak
  • Royal Oak Michigan 48073 United States
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
  • Minneapolis Minnesota 55404 United States
  • University of Minnesota/Masonic Cancer Center
  • Minneapolis Minnesota 55455 United States
  • Mayo Clinic
  • Rochester Minnesota 55905 United States
  • University of Mississippi Medical Center
  • Jackson Mississippi 39216 United States
  • Columbia Regional
  • Columbia Missouri 65201 United States
  • Children's Mercy Hospitals and Clinics
  • Kansas City Missouri 64108 United States
  • Cardinal Glennon Children's Medical Center
  • Saint Louis Missouri 63104 United States
  • Washington University School of Medicine
  • Saint Louis Missouri 63110 United States
  • Mercy Hospital Saint Louis
  • Saint Louis Missouri 63141 United States
  • Children's Hospital and Medical Center of Omaha
  • Omaha Nebraska 68114 United States
  • University of Nebraska Medical Center
  • Omaha Nebraska 68198 United States
  • University Medical Center of Southern Nevada
  • Las Vegas Nevada 89102 United States
  • Sunrise Hospital and Medical Center
  • Las Vegas Nevada 89109 United States
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  • Las Vegas Nevada 89135 United States
  • Summerlin Hospital Medical Center
  • Las Vegas Nevada 89144 United States
  • Dartmouth Hitchcock Medical Center
  • Lebanon New Hampshire 03756 United States
  • Hackensack University Medical Center
  • Hackensack New Jersey 07601 United States
  • Saint Barnabas Medical Center
  • Livingston New Jersey 07039 United States
  • Morristown Medical Center
  • Morristown New Jersey 07960 United States
  • Saint Peter's University Hospital
  • New Brunswick New Jersey 08901 United States
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
  • New Brunswick New Jersey 08903 United States
  • Newark Beth Israel Medical Center
  • Newark New Jersey 07112 United States
  • Saint Joseph's Regional Medical Center
  • Paterson New Jersey 07503 United States
  • Overlook Hospital
  • Summit New Jersey 07902 United States
  • University of New Mexico Cancer Center
  • Albuquerque New Mexico 87102 United States
  • Albany Medical Center
  • Albany New York 12208 United States
  • Montefiore Medical Center - Moses Campus
  • Bronx New York 10467 United States
  • Brooklyn Hospital Center
  • Brooklyn New York 11201 United States
  • Roswell Park Cancer Institute
  • Buffalo New York 14263 United States
  • NYU Winthrop Hospital
  • Mineola New York 11501 United States
  • The Steven and Alexandra Cohen Children's Medical Center of New York
  • New Hyde Park New York 11040 United States
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • New York New York 10016 United States
  • Mount Sinai Hospital
  • New York New York 10029 United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • New York New York 10032 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • NYP/Weill Cornell Medical Center
  • New York New York 10065 United States
  • University of Rochester
  • Rochester New York 14642 United States
  • Stony Brook University Medical Center
  • Stony Brook New York 11794 United States
  • State University of New York Upstate Medical University
  • Syracuse New York 13210 United States
  • New York Medical College
  • Valhalla New York 10595 United States
  • Mission Hospital Inc-Memorial Campus
  • Asheville North Carolina 28801 United States
  • UNC Lineberger Comprehensive Cancer Center
  • Chapel Hill North Carolina 27599 United States
  • Carolinas Medical Center/Levine Cancer Institute
  • Charlotte North Carolina 28203 United States
  • Novant Health Presbyterian Medical Center
  • Charlotte North Carolina 28204 United States
  • Duke University Medical Center
  • Durham North Carolina 27710 United States
  • East Carolina University
  • Greenville North Carolina 27834 United States
  • Wake Forest University Health Sciences
  • Winston-Salem North Carolina 27157 United States
  • Sanford Broadway Medical Center
  • Fargo North Dakota 58122 United States
  • Children's Hospital Medical Center of Akron
  • Akron Ohio 44308 United States
  • Cincinnati Children's Hospital Medical Center
  • Cincinnati Ohio 45229 United States
  • Rainbow Babies and Childrens Hospital
  • Cleveland Ohio 44106 United States
  • Cleveland Clinic Foundation
  • Cleveland Ohio 44195 United States
  • Nationwide Children's Hospital
  • Columbus Ohio 43205 United States
  • Dayton Children's Hospital
  • Dayton Ohio 45404 United States
  • The Toledo Hospital/Toledo Children's Hospital
  • Toledo Ohio 43606 United States
  • Mercy Children's Hospital
  • Toledo Ohio 43608 United States
  • University of Oklahoma Health Sciences Center
  • Oklahoma City Oklahoma 73104 United States
  • Natalie Warren Bryant Cancer Center at Saint Francis
  • Tulsa Oklahoma 74136 United States
  • Legacy Emanuel Children's Hospital
  • Portland Oregon 97227 United States
  • Legacy Emanuel Hospital and Health Center
  • Portland Oregon 97227 United States
  • Oregon Health and Science University
  • Portland Oregon 97239 United States
  • Lehigh Valley Hospital - Muhlenberg
  • Bethlehem Pennsylvania 18017 United States
  • Geisinger Medical Center
  • Danville Pennsylvania 17822 United States
  • Penn State Children's Hospital
  • Hershey Pennsylvania 17033 United States
  • Children's Hospital of Philadelphia
  • Philadelphia Pennsylvania 19104 United States
  • Saint Christopher's Hospital for Children
  • Philadelphia Pennsylvania 19134 United States
  • Children's Hospital of Pittsburgh of UPMC
  • Pittsburgh Pennsylvania 15224 United States
  • Rhode Island Hospital
  • Providence Rhode Island 02903 United States
  • Medical University of South Carolina
  • Charleston South Carolina 29425 United States
  • Prisma Health Richland Hospital
  • Columbia South Carolina 29203 United States
  • BI-LO Charities Children's Cancer Center
  • Greenville South Carolina 29605 United States
  • Greenville Cancer Treatment Center
  • Greenville South Carolina 29605 United States
  • Sanford USD Medical Center - Sioux Falls
  • Sioux Falls South Dakota 57117-5134 United States
  • T C Thompson Children's Hospital
  • Chattanooga Tennessee 37403 United States
  • East Tennessee Childrens Hospital
  • Knoxville Tennessee 37916 United States
  • St. Jude Children's Research Hospital
  • Memphis Tennessee 38105 United States
  • The Children's Hospital at TriStar Centennial
  • Nashville Tennessee 37203 United States
  • Vanderbilt University/Ingram Cancer Center
  • Nashville Tennessee 37232 United States
  • Texas Tech University Health Sciences Center-Amarillo
  • Amarillo Texas 79106 United States
  • Dell Children's Medical Center of Central Texas
  • Austin Texas 78723 United States
  • Driscoll Children's Hospital
  • Corpus Christi Texas 78411 United States
  • Medical City Dallas Hospital
  • Dallas Texas 75230 United States
  • UT Southwestern/Simmons Cancer Center-Dallas
  • Dallas Texas 75390 United States
  • Brooke Army Medical Center
  • Fort Sam Houston Texas 78234 United States
  • Cook Children's Medical Center
  • Fort Worth Texas 76104 United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  • Houston Texas 77030 United States
  • M D Anderson Cancer Center
  • Houston Texas 77030 United States
  • Covenant Children's Hospital
  • Lubbock Texas 79410 United States
  • University Medical Center
  • Lubbock Texas 79415 United States
  • Children's Hospital of San Antonio
  • San Antonio Texas 78207 United States
  • Methodist Children's Hospital of South Texas
  • San Antonio Texas 78229 United States
  • University of Texas Health Science Center at San Antonio
  • San Antonio Texas 78229 United States
  • Scott and White Memorial Hospital
  • Temple Texas 76508 United States
  • Primary Children's Hospital
  • Salt Lake City Utah 84113 United States
  • University of Vermont and State Agricultural College
  • Burlington Vermont 05405 United States
  • University of Virginia Cancer Center
  • Charlottesville Virginia 22908 United States
  • Inova Fairfax Hospital
  • Falls Church Virginia 22042 United States
  • Children's Hospital of The King's Daughters
  • Norfolk Virginia 23507 United States
  • Naval Medical Center - Portsmouth
  • Portsmouth Virginia 23708-2197 United States
  • Virginia Commonwealth University/Massey Cancer Center
  • Richmond Virginia 23298 United States
  • Carilion Clinic Children's Hospital
  • Roanoke Virginia 24014 United States
  • Seattle Children's Hospital
  • Seattle Washington 98105 United States
  • Providence Sacred Heart Medical Center and Children's Hospital
  • Spokane Washington 99204 United States
  • Mary Bridge Children's Hospital and Health Center
  • Tacoma Washington 98405 United States
  • Madigan Army Medical Center
  • Tacoma Washington 98431 United States
  • West Virginia University Charleston Division
  • Charleston West Virginia 25304 United States
  • Cabell-Huntington Hospital
  • Huntington West Virginia 25701 United States
  • Saint Vincent Hospital Cancer Center Green Bay
  • Green Bay Wisconsin 54301 United States
  • University of Wisconsin Hospital and Clinics
  • Madison Wisconsin 53792 United States
  • Marshfield Medical Center-Marshfield
  • Marshfield Wisconsin 54449 United States
  • Children's Hospital of Wisconsin
  • Milwaukee Wisconsin 53226 United States
  • John Hunter Children's Hospital
  • Hunter Regional Mail Centre New South Wales 2310 Australia
  • Sydney Children's Hospital
  • Randwick New South Wales 2031 Australia
  • The Children's Hospital at Westmead
  • Westmead New South Wales 2145 Australia
  • Royal Brisbane and Women's Hospital
  • Herston Queensland 4029 Australia
  • Royal Children's Hospital-Brisbane
  • Herston Queensland 4029 Australia
  • Queensland Children's Hospital
  • South Brisbane Queensland 4101 Australia
  • Women's and Children's Hospital-Adelaide
  • North Adelaide South Australia 5006 Australia
  • Monash Medical Center-Clayton Campus
  • Clayton Victoria 3168 Australia
  • Royal Children's Hospital
  • Parkville Victoria 3052 Australia
  • Princess Margaret Hospital for Children
  • Perth Western Australia 6008 Australia
  • Perth Children's Hospital
  • Perth Western Australia 6009 Australia
  • Alberta Children's Hospital
  • Calgary Alberta T3B 6A8 Canada
  • University of Alberta Hospital
  • Edmonton Alberta T6G 2B7 Canada
  • British Columbia Children's Hospital
  • Vancouver British Columbia V6H 3V4 Canada
  • CancerCare Manitoba
  • Winnipeg Manitoba R3E 0V9 Canada
  • Janeway Child Health Centre
  • Saint John's Newfoundland and Labrador A1B 3V6 Canada
  • IWK Health Centre
  • Halifax Nova Scotia B3K 6R8 Canada
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Hamilton Ontario L8N 3Z5 Canada
  • Kingston Health Sciences Centre
  • Kingston Ontario K7L 2V7 Canada
  • Children's Hospital
  • London Ontario N6A 5W9 Canada
  • Children's Hospital of Eastern Ontario
  • Ottawa Ontario K1H 8L1 Canada
  • Hospital for Sick Children
  • Toronto Ontario M5G 1X8 Canada
  • The Montreal Children's Hospital of the MUHC
  • Montreal Quebec H3H 1P3 Canada
  • Centre Hospitalier Universitaire Sainte-Justine
  • Montreal Quebec H3T 1C5 Canada
  • Allan Blair Cancer Centre
  • Regina Saskatchewan S4T 7T1 Canada
  • Saskatoon Cancer Centre
  • Saskatoon Saskatchewan S7N 4H4 Canada
  • Centre Hospitalier Universitaire de Quebec
  • Quebec G1V 4G2 Canada
  • Schneider Children's Medical Center of Israel
  • Petah Tikua 49202 Israel
  • Starship Children's Hospital
  • Grafton Auckland 1145 New Zealand
  • Christchurch Hospital
  • Christchurch 8011 New Zealand
  • Wellington Children's Hospital
  • Wellington 6002 New Zealand
  • San Jorge Children's Hospital
  • San Juan 00912 Puerto Rico
  • University Pediatric Hospital
  • San Juan 00926 Puerto Rico
  • Swiss Pediatric Oncology Group - Bern
  • Bern 3010 Switzerland

View trial on ClinicalTrials.gov


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Phase II Trial of Ixazomib Combined With Gemcitabine and Doxorubicin in Patients With Renal Medullary Carcinoma


Condition: Metastatic Kidney Medullary Carcinoma, Metastatic Renal Cell Carcinoma, SMARCB1 Negative, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

Intervention:

  • Drug: Doxorubicin
  • Drug: Doxorubicin Hydrochloride
  • Drug: Gemcitabine
  • Drug: Gemcitabine Hydrochloride
  • Drug: Ixazomib
  • Drug: Ixazomib Citrate

Purpose: This phase II trial studies how well ixazomib, gemcitabine, and doxorubicin work in treating patients with kidney cancer that has spread to other places in the body. Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ixazomib, gemcitabine, and doxorubicin may work better in treating patients with kidney cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03587662

Sponsor: M.D. Anderson Cancer Center

Primary Outcome Measures:

  • Measure: Objective response (complete response or partial response) assessed by Response Evaluation Criteria in Solid (RECIST) 1.1
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Disease control (stable disease or better) measured by RECIST 1.1
  • Time Frame: At week 28
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: From treatment start date until death from any cause (event) or last contact date for patients last known to be alive (censor), assessed up to 2 years
  • Safety Issue:
  • Measure: Progression-free survival
  • Time Frame: From treatment start date until progression (event) or death from any cause (event), assessed up to 2 years
  • Safety Issue:
  • Measure: Duration of response
  • Time Frame: From first documented response until progression (event) or death from any cause (event), assessed up to 2 years
  • Safety Issue:
  • Measure: Biomarker analysis of biomarkers PDI, BiP, eIF2aP assessed in tumor tissue samples
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: IL-6 measured serum samples
  • Time Frame: Up to 2 years
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: August 17, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 12 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patients with locally advanced or metastatic RMC histologically confirmed by expert pathology review and loss of SMARCB1 staining by immunohistochemistry. Also eligible are patients with other rare SMARCB1-negative tumors of the kidney, such as advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare RMC variant occurring in individuals without sickle hemoglobinopathies), and adult-onset malignant rhabdoid tumors. The principal investigator (PI) is the final arbiter in questions related to eligibility.
  • Patients will be eligible regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ. Patients with prior nephrectomy can be screened for enrollment at any time following the procedure.
  • Patients must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures >= 15 mm with conventional techniques or >= 10 mm with more sensitive techniques such as magnetic resonance imaging (MRI) or spiral computed tomography (CT) scan. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. Patients with disease confined to bone may be eligible if a measurable lytic defect is present or a serum marker is elevated (> 4 x upper limit of normal [ULN]). The PI is the final arbiter in questions related to measurability.
  • Patients can have received prior immunotherapies such as anti-PD1, anti-PD-L1, or anti-CTLA-4 immune checkpoint inhibitors, or targeted therapies such as sunitinib, pazopanib, axitinib, cabozantinib, bevacizumab, erlotinib, and everolimus, or any cytotoxic chemotherapy regimens with the exception of regimens using a combination of gemcitabine >= 800 mg/m^2 plus adriamycin >= 30 mg/m^2. In addition, the total lifetime dose of doxorubicin prior to enrollment must not exceed 382 mg/m^2 as these would preclude patients from receiving at least 4 cycles of induction therapy of the trial protocol. Patients must not have received any proteasome inhibitors such as bortezomib or carfilzomib.
  • There must be evidence of progression on or after last treatment regimen received.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2. NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair, subject is considered to be ambulatory for the purpose of assessing their performance status.
  • Adolescent patients age 12 years and older are allowed with signed assent and parental consent according to institutional guidelines and requirements, as long as their body surface area (BSA) is >=1.2 given that this is the lower limit for which the independence between BSA and ixazomib exposure has been ascertained.
  • Hemoglobin >= 9 g/dl (treatment allowed). May receive transfusion (within 14 days of the first dose of the study drugs).
  • Absolute neutrophil count >= 1000/uL. Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days (within 14 days of the first dose of the study drugs).
  • Platelets >= 75,000/uL. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment (within 14 days of the first dose of the study drugs).
  • Total bilirubin =< 1.5 mg/dl. For patients with Gilbert's disease, total bilirubin should be =< 3 mg/dL (=< 51.3 umol/L) (within 14 days of the first dose of the study drugs).
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN, except in known hepatic metastasis, wherein may be =< 5 x ULN as per current American Society of Clinical Oncology recommendations. Approximately 15% of patients with RMC develop liver metastases (within 14 days of the first dose of the study drugs).
  • Creatinine clearance > 30 mL/kg/1.73 m^2. If creatinine is not < 1.5 x ULN, then calculate by Cockcroft-Gault methods or local institutional standard (within 14 days of the first dose of the study drugs).
  • International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN prior to study entry. Therapeutic anticoagulation with warfarin is allowed if target INR =< 3 on a stable dose of warfarin or other oral anticoagulant, or on a stable dose of low molecular weight (LMW) heparin for > 2 weeks (14 days) at the time of enrollment. Patients who have liver metastases resulting in INR and/or PTT > 1.5 x ULN and require chronic (>= 3 months) anticoagulation are not allowed.
  • Patients must have a measured ejection fraction of at least 45% as measured by either multigated acquisition (MUGA) scan, echocardiogram, stress test, or ventriculography.
  • Patients with controlled brain metastases are allowed on protocol if they have solitary brain metastasis that is asymptomatic and not requiring treatment or that was surgically resected or treated with radiosurgery or gamma knife, without recurrence or edema for 1 month (4 weeks).
  • Female patients who
  • Are postmenopausal for at least 1 year before the screening visit, OR
  • Are surgically sterile, OR
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of the study drug.
  • Women must not be breastfeeding.
  • WOCBP must agree to practice 2 effective method(s) of contraception, at the same time, from the time of enrollment for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post treatment completion, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs.
  • Abstinence is only acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, profession of abstinence for entry into a clinical trial, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.
  • Men who are sexually active with WOCBP, even if surgically sterilized (i.e., status post-vasectomy), must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 90 days duration of sperm turnover) for a total of 5 months post-treatment completion.
  • Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However WOCBP must still undergo pregnancy testing as described in these sections.

Exclusion Criteria:

  • Patients diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. Patients with another malignancy on watch and wait without any needing of treatment can be enrolled in this study.
  • Patients must not have received anticancer therapies (including chemotherapy and targeted therapy) within 2 weeks (14 days) or 5 half-lives (whichever is shorter) prior to study day 1. Patients who have completed palliative radiation therapy more than 14 days prior to study day 1 are eligible. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.
  • Patients, who have had a major surgery or significant traumatic injury (injury requiring > 4 weeks [28 days] to heal) within 4 weeks (28 days) of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that are expected to require major surgery, other than cytoreductive nephrectomy +/- retroperitoneal lymph node dissection, during the course of the study.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test (regardless of HBV deoxyribonucleic acid [DNA] levels or IgM hepatitis B virus core antibody [anti-HBc] status) or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. If hepatitis C antibody test is positive then active infection has to be confirmed by hepatitis C RNA testing for the patient to be excluded.
  • Patient has >= grade 3 peripheral neuropathy, or grade 2 peripheral neuropathy with pain on clinical examination during the screening period.
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib, including difficulty swallowing, refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes. The PI is the final arbiter in questions related to eligibility.
  • Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
  • Patients receiving any concomitant systemic therapy for renal cell cancer are excluded.
  • Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • Symptomatic congestive heart failure of New York heart Association class III or IV.
  • Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.
  • Severely impaired lung function as defined as oxygen (O2) saturation that is 92% or less at rest on room air.
  • Uncontrolled diabetes as defined by fasting serum glucose > 1 .5 x ULN.
  • Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment.
  • Known active or symptomatic viral hepatitis or chronic liver disease. Uncontrolled adrenal insufficiency.
  • Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ixazomib, gemcitabine, or doxorubicin, or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods as defined above. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception.
  • Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior chemotherapy.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.

Contact:

  • Pavlos Msaouel
  • 713-792-2830

Location:

  • M D Anderson Cancer Center
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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NAXIVA- Phase II Neoadjuvant Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Clear Cell Renal Cell Cancer With Venous Invasion


Condition: Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Non-metastatic Renal Cell Carcinoma

Intervention:

  • Drug: Axitinib Oral Tablet

Purpose: NAXIVA is a study of axitinib in patients with metastatic and non-metastatic renal cell carcinoma with venous invasion. Patients will be given axitinib (twice daily) for 8 weeks (at an escalated dose) and the response of the venous invasion will be assessed. Blood, urine and tumour tissue samples will be taken prior to and during therapy to evaluate biomarkers of treatment response. The primary objective is to assess the response of the thrombus to axitinib. Its thought that axitinib will reduce the extent of the thrombus in the inferior vena cava will reduce the extent of surgical intervention.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03494816

Sponsor: Scottish Clinical Trials Research Unit

Primary Outcome Measures:

  • Measure: Improvement in Mayo Classification
  • Time Frame: Surgery and radiology assessment at week 9 in comparison to pre-axitinib assessment.
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Surgical approach
  • Time Frame: Surgical planning will be conducted at week 1 (prior to axitinib) and compared to the actual outcome at week 9.
  • Safety Issue:
  • Measure: Venous Tumour Thrombus (VTT) height
  • Time Frame: Radiology assessment- The VTT height will be measured prior to axitinib and compared with the VTT height just before surgery (week 9). Both pre-axitinib and week 9 scans will be centrally reviewed by the lead NAXIVA radiologists prior to analysis.
  • Safety Issue:
  • Measure: Response rate
  • Time Frame: Radiology assessment- The response rate (RECIST) will be assessed at week 9 in comparison to pre-axitinib measurements.Both pre-axitinib and week 9 scans will be centrally reviewed by the lead NAXIVA radiologists prior to analysis.
  • Safety Issue:
  • Measure: Morbidity rates
  • Time Frame: Morbidity rates will be assessed by radiology assessment using pre-axitinib and week 9 scans. Both pre-axitinib and week 9 scans will be centrally reviewed by the lead NAXIVA radiologists prior to analysis.
  • Safety Issue:

Estimated Enrollment: 20

Study Start Date: December 15, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • 1. Age ≥ 18. 2. Histologically proven clear cell RCC. 3. Immediate resection of the primary tumour considered technically possible. 4. Suitable for and willing to undergo nephrectomy (either cytoreductive or with curative intent) 4. cT3b, cT3c, cT3a (main renal vein) 5. N0, N1, or Nx 6. M0, or M1 7. ECOG performance status 0
  • 1 8. Urinalysis <2+ protein. If dipstick is ≥2+ then a 24-hour urine collection should be performed and the patient may enter NAXIVA only if urinary protein is <2g per 24 hours. 9. All female patients with reproductive potential must have a negative serum or urine pregnancy test within a maximum of 14 days prior to starting trial treatment.

Exclusion Criteria:

  1. For M1 patients: poor risk on Memorial Sloan Kettering Cancer Centre (MSKCC) score and deemed suitable for cytoreductive nephrectomy at time of enrolment.
  2. The presence of active second malignancy. Patients will be eligible if they have adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, stable prostate cancer or if treated with curative intent for any other cancer with no evidence of disease for 2 years. Patients with prostate cancer will be permitted entry if not receiving treatment and prostrate-specific antigen (PSA) is not rising.
  3. Women who are pregnant or are breastfeeding. Female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy and up to 1 week after treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after completion of study drug (Patients who do not meet this will not be are not eligible).
  4. Current signs or symptoms of severe progressive or uncontrolled hepatic, endocrine or pulmonary disease other than directly related to RCC.
  5. Gastrointestinal abnormalities including: a. inability to take oral medication; b. requirement for intravenous alimentation; c. prior surgical procedures affecting absorption including total gastric resection; d. treatment for active peptic ulcer disease in the past 6 months; e. active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; f. malabsorption syndromes.
  6. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (see section 4.4, concomitant therapy).
  7. Current use, or anticipated need for treatment with, drugs that are known CYP3A4 inducers or substrates for CYP1A2 (see section 4.4, concomitant therapy).
  8. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access device or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
  9. Active seizure disorder, spinal cord compression, or carcinomatous meningitis.
  10. Any of the following within 12 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack.
  11. Uncontrolled hypertension (>160/100 mmHg despite optimised antihypertensive treatment).
  12. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  13. ALT or AST ≥ 1.5 x ULN; Bilirubin ≥ 1.5 x ULN.
  14. Serum creatinine ≥ 1.5 x ULN
  15. Neutrophil count < 1.0 x 109/L; platelet count < 100 x 109/L; Hb ≤ 90g/L.
  16. Known severe hepatic impairment (Child-Pugh class C)
  17. Known hypersensitivity to axitinib or any of its excipients. Specifically patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not enter the study.

Contact:

  • Niki Couper
  • 0131 275 6727

Locations:

  • Addenbrookes Hospital
  • Cambridge CB2 0QQ United Kingdom
  • Western General Hospital
  • Edinburgh EH4 2XU United Kingdom
  • Beatson West of Scotland Cancer Centre
  • Glasgow G12 0YN United Kingdom
  • St George's Hospital
  • London SW17 0QT United Kingdom
  • Royal Marsden
  • London SW3 6JJ United Kingdom
  • The Christie
  • Manchester M20 4BX United Kingdom

View trial on ClinicalTrials.gov


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Biomarker Study of Patients With Metastatic Clear Cell Renal Carcinoma (ccRCC) Undergoing Sequential Therapy With 1st Line Sunitinib and 2nd Line Axitinib


Condition: Clear Cell Renal Cell Carcinoma

Intervention:

  • Drug: Sunitinib

Purpose: This is a prospective single arm phase II study to evaluate potential prognostic and/or predictive biomarkers in patients with metastatic ccRCC undergoing treatment with 1st line sunitinib on a 4/2 schedule followed by axitinib on 2nd line therapy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03592199

Sponsor: Instituto do Cancer do Estado de São Paulo

Primary Outcome Measures:

  • Measure: 1st line Response Rate (RR) with Sunitinib in patients with VEGF pathway mutation
  • Time Frame: through study completion (up to 2 years)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: 1sr line RR with Sunitinib
  • Time Frame: through study completion (up to 2 years)
  • Safety Issue:
  • Measure: 2nd Line RR with Axitinib
  • Time Frame: through study completion (up to 2 years)
  • Safety Issue:
  • Measure: 1st line PFS with Sunitinib
  • Time Frame: through study completion (up to 2 years)
  • Safety Issue:
  • Measure: 2nd PFS with Axitinib
  • Time Frame: through study completion (up to 2 years)
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: through study completion (up to 2 years)
  • Safety Issue:
  • Measure: Incidence of Treatment-Emergent Adverse Events
  • Time Frame: through study completion (up to 2 years)
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: December 11, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Diagnosis of Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to American Joint Committee on Cancer staging) renal cell carcinoma;
  • Histologic confirmed clear cell renal cell carcinoma;
  • No prior systemic therapy (interleukin-2, interferon-α, chemotherapy, bevacizumab, sunitinib, sorafenib, pazopanib, axitinib, everolimus or temsirolimus) for advanced or metastatic RCC;
  • Measurable disease by RECIST;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2;
  • Adequate organ system functions;
  • Patients must understand and be willing to sign the written informed consent form of this study.

Exclusion Criteria:

  • Non-clear cell renal cell carcinoma
  • Pregnant or lactating female.
  • History of another malignancy. Note: Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin carcinoma or successfully treated in situ carcinoma are eligible.
  • History or clinical evidence of central nervous system (CNS) metastases. Note: Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery) and meet all 3 of the following criteria are eligible: 1. Are asymptomatic 2. No evidence of active CNS metastases for ≥3 months prior to enrolment 3. Have no requirement for steroids or anticonvulsants
  • Clinically significant gastrointestinal abnormalities including, but not limited to: 1. Malabsorption syndrome 2. Major resection of the stomach or small bowel that could affect the absorption of study drug 3. Active peptic ulcer disease 4. Inflammatory bowel disease 5. Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation 6. History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 28 days prior to beginning study treatment.
  • History of any one or more of the following cardiovascular conditions within the past 12 months: 1. Cardiac angioplasty or stenting 2. Myocardial infarction 3. Unstable angina 4. Symptomatic peripheral vascular disease 5. Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) 6. History of cerebrovascular accident including transient ischemic attack (TIA). 7. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥150 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) of ≥ 90 mmHg

Location:

  • Instituto do Cancer do Estado de São Paulo
  • São Paulo 01246000 Brazil

View trial on ClinicalTrials.gov


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Prospective Validation of Circulating Tumor Cells (CTCs) and Circulating Endothelial Cells (CECs) as Prognostic Biomarkers in Clear Cell Renal Cancer


Condition: Clear Cell Renal Cancer, Circulating Tumor Cells, Circulating Endothelial Cells, Prognostic Biomarkers, Predictive Biomarkers

Intervention:

  • Other: None- observational study

Purpose: Circulating tumor cells (CTCs) have prognostic value in several tumor types, and increasing evidence suggests that molecular characterization of CTCs can serve as a "liquid biopsy" to understand and address treatment resistance. The goal of this proposal is to demonstrate that CTCs can be accurately enumerated and characterized in metastatic clear cell renal cancer (CCRC) and can serve as prognostic/predictive biomarkers to improve treatment. The challenge surrounding CTC analysis in CCRC is that most CTC technologies (including the clinical gold-standard CellSearch®) depend in epithelial markers such as EpCAM that are expressed at low or heterogeneous levels in CCRC. Members of the research team have developed a novel CTC microfluidic technology that can effectively detect CTCs that are completely undetectable by CellSearch® because of very low EpCAM expression, as well as allowing for CTC recovery for downstream molecular characterization. The goal of this proposal is therefore to test the hypotheses that (1) The microfluidics CTC technology will have better sensitivity/specificity relative to the CellSearch in metastatic CCRC; and (2) Enumeration of CTCs in metastatic CCRC patients (n=66) will have prognostic value, while molecular characterization of CTCs for expression of biomarkers (VHL, VEGF, mTOR, HIF1/HIF2, AKT) related to CCRC etiology will be predictive of response/resistance to targeted therapies. Although CCRC is relatively uncommon, the lack of established adjuvant treatments and high cost of targeted therapies in the palliative setting makes the search for new prognostic/predictive biomarkers an important clinical goal.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02499458

Sponsor: Lawson Health Research Institute

Primary Outcome Measures:

  • Measure: Sensitivity/specificity of CTC enumeration (microfluidics vs CellSearch)
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Progression free survival (PFS).
  • Time Frame: 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival (OS)
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Radiological response
  • Time Frame: within 16 weeks after start of study
  • Safety Issue:
  • Measure: Molecular characterization of CTCs
  • Time Frame: baseline, 4-6 weeks after start of therapy, 10-12 weeks after start of therapy, post-progression (up to 24 months)
  • Safety Issue:
  • Measure: Enumeration of CECs
  • Time Frame: baseline, 4-6 weeks after start of therapy, 10-12 weeks after start of therapy, post-progression (up to 24 months)
  • Safety Issue:

Estimated Enrollment: 70

Study Start Date: November 2014

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  1. ECOG performance status 0-2
  2. Age over 18 years
  3. Diagnosed renal cancer with clear cell histology
  4. Metastatic disease
  5. Predicted life expectancy over 2 months
  6. Targeted treatment with an anti-VEGF or anti-mTOR agent as first or second line therapy
  7. Standard imaging evaluation 4 weeks prior to inclusion
  8. Planned for standard imaging within 16 weeks after start of therapy

Exclusion Criteria:

  1. Presence of substantial comorbidities (uncontrolled heart or respiratory dysfunction, severe renal or hepatic impairment [Cl Cr below 30ml/h OR Bb>3X ULN])
  2. History of a malignancy other than non-melanoma skin cancer in the previous 5 years
  3. Any other contraindication to targeted treatments.

Contact:

  • Alison L Allan, PhD
  • 519-685-8600 Ext. 55134

Location:

  • London Health Sciences Centre
  • London Ontario N6K 4L6 Canada

View trial on ClinicalTrials.gov


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A Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602).


Condition: Renal Cell Carcinoma, Papillary Renal Cell Carcinoma Type 1, Papillary Renal Cell Carcinoma Type 2, Chromophobe Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Xp11 Translocation Carcinoma

Intervention:

  • Drug: Nivolumab
  • Drug: Ipilimumab

Purpose: This study aims to evaluate the safety, tolerability and effectiveness of new treatments for kidney cancer called Nivolumab and Ipilimumab. The study is in two parts; in the first instance patients receive nivolumab alone. If this treatment is not effective patients may move onto the second part of the trial, where they receive nivolumab + ipilimumab. There is no placebo. The reason to offer one treatment alone, followed by two treatments together is that it is thought that the double treatment may have more side-effects, but also may be effective in people in whom the single first treatment (nivolumab alone) has not helped. Nivolumab and ipilimumab are experimental treatments. This means that they are not an approved treatment for non-clear cell kidney cancer in Australia. The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab (also known as Opdivo or BMS-936558) and Ipilumumab (also known as MDX-010 or Yervoy). Nivolumab and ipilimumab are antibodies (a type of human protein) that are being tested to see if they will allow the body's immune system to work against tumour cells. The immune system is the body's defence against cancer, bacteria and viruses. The effectiveness of nivolumab and ipilimumab in cancer of the kidney will be assessed by measuring the size of patient tumours via CT scans. Nivolumab and ipilimumab have been used alone or in combination in many other cancers, and are licenced for use in other cancers like advanced melanoma and bladder cancer in Australia. They have not been tested in people with non-clear cell kidney cancer. About 85 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia and New Zealand. This research study has been initiated by Dr. Craig Gedye, is being conducted in collaboration with the Centre for Biostatistics and Clinical Trials (BaCT) and sponsored in Australia by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group Pty Ltd. Bristol Myers Squibb (BMS) is supplying the study drugs and grant funding for this research.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03177239

Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Primary Outcome Measures:

  • Measure: The objective tumour response rate, as assessed by RECIST1.1
  • Time Frame: Through study completion, on average 5 years.
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Duration of objective tumour response, as assessed by RECIST1.1
  • Time Frame: Through study completion, on average 5 years.
  • Safety Issue:
  • Measure: Progression-free survival (PFS), as assessed by RECIST1.1
  • Time Frame: Through study completion, on average 5 years.
  • Safety Issue:
  • Measure: Immune-related tumour response rate, as assessed by irRECIST.
  • Time Frame: Through study completion, on average 5 years.
  • Safety Issue:
  • Measure: Immune-related disease control rate (irDCR6), as assessed by irRECIST.
  • Time Frame: At 6 months during treatment.
  • Safety Issue:
  • Measure: The number of patients alive at the end of the study, as assessed by date of death.
  • Time Frame: Through study completion, on average 5 years.
  • Safety Issue:
  • Measure: The number of patients with adverse events, particularly immune-related adverse events, that are related to study drug, as assessed and graded according to CTCAE v4.03.
  • Time Frame: From time of patient registration, until 30 days after the last dose of treatment.
  • Safety Issue:
  • Measure: The number of participants with permanent discontinuation of treatment or delays due to toxicity, as assessed and graded according to CTCAE v4.03.
  • Time Frame: From time of patient registration, until 30 days after the last dose of treatment.
  • Safety Issue:

Estimated Enrollment: 85

Study Start Date: October 19, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • 1. Histologically confirmed unresectable, locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic nccRCC (both treatment-naïve or those treated with a VEGFR TKI or another systemic medical therapy). Non-clear cell histology including:
  • Papillary renal cell carcinoma (type 1)
  • Papillary renal cell carcinoma (type 2)
  • Other: including chromophobe renal cell carcinoma, sarcomatoid renal cell carcinoma, Xp11 translocation (TFE3+ IHC) carcinoma, other renal carcinoma NOS 2. Be ≥18 years of age on the day of signing informed consent 3. At least 1 target lesion according to RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. Adequate bone marrow function (should be performed within 14 days prior to registration and with values within the ranges specified below):
  • Haemoglobin ≥ 90g/L
  • Platelets ≥ 100x109/L
  • Neutrophil count ≥ 1.5x109/L 6. Adequate liver function (should be performed within 14 days prior to registration and with values within the ranges specified below):
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for participants with known Gilbert's syndrome who can have total bilirubin < 3.0 mg/dL
  • AST or ALT ≤ 3.0 x ULN (or ≤ 5.0x ULN in the presence of liver metastases) 7. Adequate renal function (should be performed within 14 days prior to registration and with values within the ranges specified below):
  • Creatinine ≤ 1.5x ULN OR
  • Creatinine clearance (CrCl) ≥ 30mL/min (use Cockcroft-Gault Formula) 8. Female participants of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to registering the patient. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 9. Female participants of childbearing potential should be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. 10. Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. 11. Able to provide a formalin-fixed paraffin embedded (FFPE) tumour block, representative of the participant's primary or metastatic disease (preferred), which must be forwarded to the Centre for Biostatistics and Clinical Trials (BaCT) within 10 working days post registration 12. Willing and able to start treatment within 14 days of registration, and to comply with all study requirements, including the timing and/or nature of the required treatment and assessments 13. Has provided signed, written informed consent.

Exclusion Criteria:

  1. Urothelial or transitional cell carcinoma of the renal pelvis or ureter
  2. Predominant clear cell renal cell carcinoma. A minority of clear cell histology (<50%) is acceptable, but there must be >50% non-clear cell histology predominant.
  3. Participation in a study of an investigational agent within 30 days of registration.
  4. Prior treatment with nivolumab, ipilimumab, or with any other anti-PD-1, anti-PD-L1, Anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways (NB Participant is eligible for Part 2 of the study if they took nivolumab monotherapy in Part 1 of the study).
  5. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  6. Any condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone or equivalent dose of alternative corticosteroid) or other immunosuppressive medications within 14 days of registration. Intranasal, inhaled or topical steroids are permitted in the absence of active autoimmune disease. Participants are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  7. Untreated brain or leptomeningeal metastases or current clinical or radiological progression of known brain metastases or requirement for steroid therapy for brain metastases. Participants with treated brain metastases are eligible if they have been stable and off steroids for ≥ 3 weeks.
  8. Prior allogeneic organ transplant, inflammatory bowel disease, pneumonitis, tuberculosis, or primary immunodeficiency
  9. Active infection requiring systemic therapy within 14 days before registration.
  10. Receipt of live attenuated vaccination within 30 days of registration.
  11. Life expectancy of less than 3 months.
  12. Prior systemic therapy, surgery or radiation therapy within 4 weeks before registration. Note: If the participant has undergone major surgery, they must have recovered adequately before registration.
  13. History of another active malignancy within the previous 5 years, except for locally curable cancers that have been apparently cured, such as low-grade thyroid carcinoma, prostate cancer not requiring treatment (Gleason grade ≤ 6), basal or squamous cell skin cancer, superficial bladder cancer, melanoma in situ or carcinoma in situ of the prostate, cervix, or breast. Participants who have been free of other malignancies for ≥ 5 years prior to registration are eligible for this study.
  14. Positive test for hepatitis B virus surface antigen (HBVsAg) or antibodies to hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
  15. A history of other significant infection, including HIV. HIV testing is not mandatory unless clinically indicated.
  16. Participants should be excluded if they have a history of allergy to study drug components, or a history of severe hypersensitivity reaction to any monoclonal antibody.
  17. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
  18. Female patient is pregnant or lactating.

Contact:

  • Craig Gedye, MBBS, FRACP
  • +61 2 4014 3589

Locations:

  • Border Medical Oncology
  • Albury New South Wales 2460 Australia
  • Campbelltown Hospital
  • Campbelltown New South Wales 2560 Australia
  • Chris O'Brien Lifehouse
  • Camperdown New South Wales 2050 Australia
  • St Vincents Hospital
  • Darlinghurst New South Wales 2010 Australia
  • Northern Cancer Institute
  • French Forest New South Wales 2086 Australia
  • St. George Hospital
  • Kogarah New South Wales 2217 Australia
  • Calvary Mater Newcastle
  • Newcastle New South Wales 2298 Australia
  • Port Macquarie Base Hospital
  • Port Macquarie New South Wales 2444 Australia
  • Prince of Wales Hospital
  • Randwick New South Wales 2031 Australia
  • Tamworth Hospital - North West Cancer Centre
  • Tamworth New South Wales 2340 Australia
  • Westmead Hospital
  • Westmead New South Wales 2145 Australia
  • Sunshine Coast University Hospital
  • Birtinya Queensland 4575 Australia
  • Royal Brisbane & Women's Hospital
  • Brisbane Queensland 4000 Australia
  • Flinders Medical Centre
  • Adelaide South Australia 5000 Australia
  • Ashford Cancer Centre
  • Adelaide South Australia 5037 Australia
  • Ballarat Oncology & Haematology Services
  • Ballarat Victoria 3355 Australia
  • Box Hill Hospital - Eastern Health
  • Box Hill Victoria 3128 Australia
  • Monash Medical Centre
  • Clayton Victoria 3168 Australia
  • Fiona Stanley Hospital
  • Murdoch Western Australia 6150 Australia

View trial on ClinicalTrials.gov


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Phase II Randomized Double Blind Trial of PF-04518600, an OX40 Antibody, in Combination With Axitinib Versus Axitinib in Immune-Checkpoint Inhibitor Exposed Patients With Metastatic Renal Cell Carcinoma


Condition: Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Cancer, Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer

Intervention:

  • Biological: Anti-OX40 Antibody PF-04518600
  • Drug: Axitinib
  • Other: Laboratory Biomarker Analysis
  • Other: Placebo

Purpose: This randomized phase II trial studies how well axitinib with or without anti-OX40 antibody PF-04518600 work in treating patients with kidney cancer that has spread to other parts of the body. Biological therapies, such as anti-OX40 antibody PF-04518600, use substances made from living organisms that may may stimulate the immune system in different ways and stop tumor cells from growing. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving axitinib with or without anti-OX40 antibody PF-04518600 may work better in treating patients with kidney cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03092856

Sponsor: University of Southern California

Primary Outcome Measures:

  • Measure: Progression‐free survival (PFS)
  • Time Frame: Time from randomization until the earliest of documented disease progression (confirmed progression of disease) or death, assessed for up to 180 days
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Incidence of unacceptable toxicity
  • Time Frame: Up to the beginning of the third course (29 days)
  • Safety Issue:
  • Measure: ORR defined as either complete response or partial response occurring any time during treatment and assessed by RECIST 1.1 and immune-related RECIST (irRECIST) criteria
  • Time Frame: Up to 180 days
  • Safety Issue:

Estimated Enrollment: 104

Study Start Date: July 19, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Willing and able to provide informed consent
  • Histological confirmation of renal cell carcinoma (RCC) with a predominantly (> 50%) clear cell component
  • Metastatic RCC
  • Must have had a nephrectomy (radical or partial) and must provide the cell block from the nephrectomy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria
  • Must have progression of disease within 6 months of study enrollment after treatment with only one of the following:
  • Two prior lines of therapy: a VEGF inhibitor (other than axitinib), followed by a single agent PD-1/PDL-1 antibody, or
  • One prior line of therapy: combination of a VEGF inhibitor (other than axitinib) AND a PD1/PDL1 antibody, or
  • Additional prior systemic treatments not allowed
  • Must agree to a fresh core or excisional biopsy from a metastatic site within a 12-week window prior to enrollment; if such a biopsy is already available, cell blocks must be provided; (Note: fine needle aspiration [FNA] and bone metastases samples are not acceptable for submission); specimens from the nephrectomy and fresh biopsy must be received and assessed for adequacy of tissue by the Data Coordinating Center (DCC) (University of Southern California [USC]) prior to randomization
  • Zubrod performance status of =< 2
  • Women of childbearing potential must use method(s) of contraception; the individual methods of contraception should be determined in consultation with the treating physician or investigator
  • Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the administration of the investigational product; female patients who are not of childbearing potential as defined below, are eligible to be included (ie, meet at least one of the following criteria):
  • Have undergone a documented hysterectomy and/or bilateral oophorectomy
  • Have medically confirmed ovarian failure; or
  • Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women
  • Women must not be breastfeeding
  • Men who are sexually active with women of childbearing potential must use any contraceptive method with a failure rate of less than 1% per year
  • Contraception should be continued using two highly effective methods for a period of 90 days
  • Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) using actual weight (ideal or adjusted weights are unacceptable)
  • White blood cells (WBC) >= 2000/uL
  • Neutrophils >= 1500/uL
  • Platelets >= 100x10^3/uL
  • Hemoglobin >= 9g/dL
  • Aspartate aminotransferase (AST) =< 3 x ULN
  • Alanine aminotransferase (ALT) =< 3 x ULN
  • Bilirubin =< 1.5 x ULN

Exclusion Criteria:

  • Patients with known symptomatic brain metastases requiring systemic corticosteroids; patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable; mild neurological deficit is allowed, if it does not interfere with the ability to judge the safety on the trial
  • Prior treatment with an mTOR inhibitor (including, but not limited to, everolimus, temsirolimus, sirolimus, and ridaforolimus)
  • Prior treatment with axitinib
  • History of or active autoimmune disorders (including but not limited to: Crohn's disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease) and other conditions that compromise or impair the immune system
  • Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) -related illness
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug; inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
  • Uncontrolled adrenal insufficiency
  • Any known active chronic liver disease
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast
  • Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results
  • Prior treatment with an anti-CD137, or OX40 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways except anti-PD1, anti-PDL1/2 antibodies or ipilimumab
  • Major surgery less than 6 weeks prior to the first dose of study drug; minor surgery less than 4 weeks prior to the first dose of study drug
  • Anti-cancer therapy less than 6 weeks prior to the first dose of study drug (less than 28 days for bevacizumab) or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug
  • Presence of toxicities attributed to prior therapy other than alopecia that have not resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4) or baseline before administration of study drug
  • History of grade 3 or higher immune-mediated adverse event (including AST/ALT elevations that where considered drug related and cytokine release syndrome) that was considered related to prior immune-modulatory therapy (e.g., checkpoint inhibitors, costimulatory agents etc.) or any grade immune-related adverse events (AEs) that required immune suppressive therapy
  • Patients with intolerance to or who have had a severe (>= grade 3) allergic or anaphylactic reaction to antibodies or infused therapeutic proteins, or patients who have had a severe allergic or anaphylactic reaction to any of the substances included in the investigational product (including excipients)
  • Patients with a previous history of adriamycin treatment and are at risk of cardiac failure (New York Heart Association [NYHA] class II or above)
  • Any one of the following currently or in the previous 6 months:
  • Myocardial infarction
  • Congenital long QT syndrome
  • Torsade's de points
  • Arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), and left anterior hemiblock (bifascicular block)
  • Unstable angina, coronary/peripheral artery bypass graft
  • Symptomatic congestive heart failure (congestive heart failure [CHF] New York Heart Association class III or IV)
  • Cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism or other clinical significant episode of thrombo-embolic disease (Cases must be discussed in detail with study chair to judge eligibility; anticoagulation (heparin only, no vitamin-K antagonists or factor Xa inhibitors) will be allowed if indicated)
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade >= 2, atrial fibrillation of any grade, or QT correction using Fridericia's correction formula (QTcF) interval > 470 msec at screening (except in case of right bundle branch block, these cases must be discussed with sponsor's medical monitor)
  • Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  • Concurrent use of any medications or substances; these include steroids as they may interfere with PF-04518600 (OX40 Ab); also strong CYP3A4/5 inhibitors should be avoided (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole)
  • Presence of a malabsorption syndrome, gastrointestinal disorder, or gastrointestinal surgery that could affect the absorption of axitinib
  • History of severe hypersensitivity reaction to any monoclonal antibody
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test
  • Prisoners or patients who are involuntarily detained

Contact:

  • Cheryl Kefauver, RN
  • 323-865-0459

Locations:

  • USC / Norris Comprehensive Cancer Center
  • Los Angeles California 90033 United States
  • University of California Davis Comprehensive Cancer Center
  • Sacramento California 95817 United States
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  • Cleveland Ohio 44195 United States
  • Ohio State University Comprehensive Cancer Center
  • Columbus Ohio 43210 United States
  • University of Pittsburgh Cancer Institute (UPCI)
  • Pittsburgh Pennsylvania 15232 United States

View trial on ClinicalTrials.gov


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A Dose Escalation and Dose Expansion Trial to Assess the Safety, Tolerability and Anti-tumor Activity of Autologous T Cell Modified Chimeric Antigen Receptor (CAR) CCT 301-38 or CCT 301-59 in Patients With Recurrent or Refractory Stage IV Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Intervention:

  • Biological: CCT301-38
  • Biological: CCT301-59

Purpose: This is a two arm, open-label, dose escalation and dose expansion clinical study to evaluate the safety and efficacy of infusion of autologous CCT301-38 or CCT 301-59 T cells in adult subjects with relapsed and refractory stage IV metastatic renal cell carcinoma.Subjects with ROR2 positive biopsy will receive CCT301-59. Subjects with AXL positive biopsy that are ROR2 negative will receive CCT301-38.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03393936

Sponsor: Shanghai Sinobioway Sunterra Biotech

Primary Outcome Measures:

  • Measure: Phase I Safety (Incidence of adverse events defined as dose-limiting toxicities(DLT)
  • Time Frame: Up to 28 days from cell infusion
  • Safety Issue:
  • Measure: Phase II Objective Response Rate
  • Time Frame: Up to 9 months from cell infusion
  • Safety Issue:

Estimated Enrollment: 66

Study Start Date: March 26, 2018

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 70 Years
  • Gender: All

Inclusion Criteria:

  • 1. Men or women aged 18~70 years old. 2. Patients are diagnosed as refractory / recurrent, Stage IV renal cell carcinoma by histological method with FDG PET signal > 3 SUV in measurable metastatic lesion. 3. Patients with at least two metastatic lesions, including one measurable metastatic tumor lesion >10 mm measurable by CT. 4. Tumor tissues samples confirmed CCT301 target positive IHC. Patient with histological biopsy.
  • tumor tissue with greater than or equal to 50% positive staining by IHC method for ROR2 ;
  • tumor tissue with greater than or equal to 50% positive staining by IHC method for AXL that is ROR2 negative. 5. Expected survival ≥12 weeks. 6. ECOG 0-1 7. Adequate organ function as documented by:
  • ANC≥1.9X10^9/L
  • PLT≥100x10^9/L
  • Hb≥9.0g/dL
  • rCCR≥50ml/min
  • ALT and AST≤2.5ULN; for liver metastasis, ALT and AST ≤5ULN
  • Serum TBiL≤3.0mg/dL, TBiL≤2.5ULN 8. PT: INR < 1.7 or extended PT to normal value < 4s 9. Adequate venous access for venous blood collection, and no other contraindication of blood cell separation 10. Patients with willingness to be in this study and able to provide informed consent 11. Capable of receiving treatment and follow up, included patients are required to receive treatment in the enrolled centre 12. Women of childbearing age are required to take acceptable measures to minimize the possibility of pregnancy during whole session. Women of childbearing age must have negative results of serum or urine tests within 24 hours prior to infusion. Women patients must not be in lactation; 13. Immunological detection

Exclusion Criteria:

  1. Pregnant women or women in lactation.
  2. Active HBV or HCV infection.
  3. HIV/AIDS infection.
  4. Active infection
  5. Previously suffered from diseases or concurrent diseases as follows:
  6. Patients confirmed as severe autoimmune diseases in long-term (over 2 months) need of systemic immune inhibitors (steroid) or as immune-mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (for example, Wegener's granulomatosis)
  7. Patients with previous diagnosis as motor neuron disease caused by autoimmunity
  8. Patients previously suffered from toxic epidermal necrolysis (TEN)
  9. Patients with any mental diseases including dementia, mental status change that may impinge the understanding and performance of informed consent and related questionnaire
  10. Patients with severe, uncontrollable diseases judged by investigator that may hinder them receiving this treatment
  11. Patients with other previously active malignant tumors including basal or squamous skin cancer, superficial bladder cancer, and in situ breast carcinoma within 5 years who had been completely cured without the need of follow-up treatment are not excluded.
  12. Ongoing treatment using systemic steroid or steroid inhalants.
  13. Previous treatment used gene/cell therapy products.
  14. Previous experience of immunotherapies including CIK, DC, DC-CIK, LAK for the treatment of cancer.
  15. Allergic to immunotherapies or related drugs
  16. Patients in need of treatment for heart failure with ≥2 NYHA or for poor controlled hypertension.
  17. Patients with unstable or active peptic ulcer or alimentary tract hemorrhage.
  18. Patients with previous organ transplantation or ready for organ transplantation.
  19. Patients in need of anticoagulant therapy treatment (warfarin or heparin)
  20. Patients judged by investigators as not appropriate for this study.

Contact:

  • Tongyu Zhu
  • +8613816002121

Location:

  • Shanghai Public Health Clinical Center
  • Shanghai Shanghai 200000 China

View trial on ClinicalTrials.gov


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A Therapeutic Trial for Safety and Preliminary Efficacy of the Combination of Axitinib and Seleniomethionine (SLM) for Adult Patients With Advanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC)


Condition: Advanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC)

Intervention:

  • Drug: Selenomethionine (SLM)
  • Drug: Axitinib
  • Drug: Selenomethionine (SLM)
  • Drug: Axitinib

Purpose: This is a Phase I/II trial for safety and preliminary efficacy of the combination of axitinib and selenomethionine (SLM) for adult patients with advanced metastatic clear cell renal cell carcinoma (CCRCC). This will be a two part study consisting of a dose escalation and expansion study.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02535533

Sponsor: Yousef Zakharia

Primary Outcome Measures:

  • Measure: Incidence of adverse events (AE) per CTCAE 4.03
  • Time Frame: After 2 cycles (28 days)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Tumor Response rate as assessed by RECIST v.1.1
  • Time Frame: After 2 cycles (28 days)
  • Safety Issue:
  • Measure: Progression free survival (PFS)
  • Time Frame: 14 months
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 35

Study Start Date: January 2016

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histologically and radiologically confirmed advanced metastatic CCRCC in patients who have had at least one prior systemic therapy, which can include axitinib for the dose escalation part. In the expansion part, patients with prior axitinib use will be excluded.
  • Written and voluntary informed consent.
  • At least one Response Evaluation Criteria In Solid Tumors (RECIST)-defined target lesion. *Patient must have documented disease progression.
  • Renal function (creatinine level within normal institutional limit, or creatinine clearance >15 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula).
  • Liver function (AST/ALT <2.5 X institutional upper limit of normal OR <5 X institutional upper limit of normal in cases of liver metastases; Total bilirubin ≤ 1.5 times ULN.)
  • Adequate hematological lab values including: Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L, Platelets ≥ 100 x 109/L, Hemoglobin ≥ 9.0 g/dL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 (fully active, able to carry on all pre-disease performance without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work) or 2 (Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours).
  • Age of at least 18 years.
  • Life expectancy of 12 weeks and more.
  • 2 weeks or more since end of previous systemic treatment (4 weeks or more for bevacizumab plus interferon-alfa). 3 days wash out for palliative radiation.

Exclusion Criteria:

  • Any other cancer from which the patient has been disease-free for less than 5 years (except treated and cured basal-cell or squamous-cell skin cancer, superficial bladder cancer, or treated carcinoma in situ of the cervix, breast, or bladder and treated localized prostate cancer with undetectable PSA for 2 years).
  • Symptomatic untreated metastases in the central nervous system.
  • Subject that is pregnant or lactating
  • Pre-existing uncontrolled hypertension defined as > 150/90 mm Hg with medication.
  • Present use or anticipated need for cytochrome P450 (CYP) 3A4-inhibiting, CYP3A4-inducing drugs (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and St. John's wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin).Myocardial infarction, uncontrolled angina, congestive heart failure, or cerebrovascular accident within previous 6 months. Subjects with history of deep vein thrombosis or pulmonary embolism, at provider discretion.
  • Myocardial infarction, uncontrolled angina, congestive heart failure, or cerebrovascular accident within previous 12 months; and deep vein thrombosis or pulmonary embolism within previous 6 months.
  • Major surgery within 4 weeks of starting study treatment.
  • Known HIV or acquired immunodeficiency syndrome-related disease.

Contact:

  • Yousef Zakharia, MD
  • 319-384-8076

Location:

  • University of Iowa Hospitals and Clinics
  • Iowa City Iowa 52242 United States

View trial on ClinicalTrials.gov


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A Pilot Study of Daratumumab (CD38 Antagonist) in Patients With Metastatic Renal Cell Carcinoma or Muscle Invasive Bladder Cancer


Condition: Bladder Urothelial Carcinoma, Clear Cell Renal Cell Carcinoma, Malignant Urinary System Neoplasm, Metastatic Kidney Carcinoma, Stage IV Renal Cell Cancer AJCC v8

Intervention:

  • Procedure: Biopsy
  • Biological: Daratumumab
  • Other: Laboratory Biomarker Analysis
  • Procedure: Metastasectomy
  • Procedure: Nephrectomy

Purpose: Objectives: Primary: Safety and tolerability of therapy with daratumumab in a cohort of patients with metastatic renal cell carcinoma and a cohort of patients with muscle invasive bladder cancer. Secondary: 1A. To assess the proportion of patients who achieve pathological CR with daratumumab in patients with muscle invasive bladder cancer. 1B. To assess the objective response rate (ORR) to daratumumab in patients with metastatic renal cell carcinoma. 2. To assess the progression free survival for patients with metastatic renal cell carcinoma receiving Daratumumab.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03473730

Sponsor: M.D. Anderson Cancer Center

Primary Outcome Measures:

  • Measure: Incidence of adverse events
  • Time Frame: Up to 2 weeks after completion of study treatment (bladder cohort) or 6 weeks post-surgery (renal cohort)
  • Safety Issue:
  • Measure: Rate of surgical delay (Bladder cohort)
  • Time Frame: Up to 2 weeks after completion of study treatment
  • Safety Issue:
  • Measure: Incidence of surgical complications (Bladder cohort)
  • Time Frame: At 30 days post-surgery
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Pathologic response (Bladder cohort)
  • Time Frame: Up to 2 weeks after completion of study treatment
  • Safety Issue:
  • Measure: Best objective response rate (ORR) (Renal cohort)
  • Time Frame: Up to 2 weeks after completion of study treatment
  • Safety Issue:
  • Measure: Progression-free survival (PFS) (Renal cohort)
  • Time Frame: From the start of study treatment up to 6 weeks post-surgery
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: May 29, 2018

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • RENAL & BLADDER COHORT: Consent to Monroe Dunaway (MD) Anderson laboratory protocol PA13-0291
  • RENAL COHORT: Histological documentation of renal cell carcinoma with a clear cell component in the metastatic renal cell carcinoma cohort
  • RENAL COHORT: Patients with an outside biopsy within 12 months is allowed for entry requirements; during the screening phase, patients without a tissue diagnosis may undergo a renal biopsy for histologic confirmation on PA13-0291
  • RENAL COHORT: Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria in at least one site that is not the site for planned surgical resection or serial biopsy
  • RENAL COHORT: If the kidney primary tumor is in place this is the preferred site of biopsy
  • RENAL COHORT: Patients who have progression of disease or intolerance to a tyrosine kinase inhibitor (TKI) and to a PD-1 (like nivolumab) or PD-L1 (like atezolizumab) regimen; there is no limit to number of prior treatment regimens as long as the patient meets other

Eligibility Criteria:

  • RENAL & BLADDER: Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s)
  • RENAL & BLADDER: Female subjects of childbearing potential must not be pregnant at screening; females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy); however, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons
  • RENAL & BLADDER: Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of =< 2
  • RENAL COHORT: Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 from toxicities related to any prior treatments, unless adverse events (AEs) are clinically nonsignificant and/or stable on supportive therapy
  • RENAL COHORT: Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support (within 4 days before the first dose of daratumumab)
  • RENAL COHORT: Platelets >= 100,000/mm^3 (within 4 days before the first dose of daratumumab)
  • RENAL COHORT: Hemoglobin >= 9 g/dL (within 4 days before the first dose of daratumumab)
  • RENAL COHORT: Bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dL (within 4 days before the first dose of daratumumab)
  • RENAL COHORT: Serum albumin >= 2.8 g/dl (within 4 days before the first dose of daratumumab)
  • RENAL COHORT: Serum creatinine clearance (CrCl) >= 20 mL/min (within 4 days before the first dose of daratumumab); dialysis patients will be excluded; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
  • RENAL COHORT: Serum phosphorus >= lower limit of normal (LLN) (within 4 days before the first dose of daratumumab)
  • RENAL COHORT: Calcium >= LLN (within 4 days before the first dose of daratumumab)
  • RENAL COHORT: Magnesium >= LLN (within 4 days before the first dose of daratumumab)
  • RENAL COHORT: Potassium >= LLN (within 4 days before the first dose of daratumumab)
  • RENAL & BLADDER: Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study
  • BLADDER: Histological documentation of urothelial cancer either on outside transurethral bladder biopsy or on initial transurethral bladder biopsy at MD Anderson under PA13-0291
  • BLADDER: Patients may not have evidence of metastatic disease on baseline computed tomography (CT) or magnetic imaging resonance of the chest, abdomen, or pelvis
  • BLADDER: Patients must be considered to be an operative candidate by the urology service at MD Anderson Cancer Center
  • BLADDER: The patient must be systemic treatment naive, previous intra-vesicle therapy is allowed
  • BLADDER: Subjects must be considered cisplatin ineligible as per treating physician due to renal dysfunction, hearing impairment, or co-morbidities; cisplatin ineligibility defined as: glomerular filtration rate (GFR) less than 60; congestive heart failure (CHF) New York Heart Association (NYHA) class III or higher; peripheral neuropathy grade 2 or higher; ECOG PS 2 or higher; impaired hearing
  • BLADDER: ANC >= 1500/mm^3 without colony stimulating factor support (clinical laboratory values at screening)
  • BLADDER: Platelets >= 100,000/mm^3 (clinical laboratory values at screening)
  • BLADDER: Hemoglobin >= 9 g/dL (clinical laboratory values at screening)
  • BLADDER: Bilirubin =< 1.5 x the ULN; for subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dL (clinical laboratory values at screening)
  • BLADDER: Serum albumin >= 2.8g/dl (clinical laboratory values at screening)
  • BLADDER: Serum creatinine clearance (CrCl) >= 20 mL/min (clinical laboratory values at screening); dialysis patients will be excluded; for creatinine clearance estimation, the Cockcroft and Gault equation should be used
  • BLADDER: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 x ULN (clinical laboratory values at screening)
  • BLADDER: Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study

Exclusion Criteria:

  • RENAL & BLADDER: Currently enrolled in another interventional study
  • RENAL COHORT: The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
  • RENAL COHORT: Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before the first dose of study treatment; eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment
  • RENAL & BLADDER: Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection
  • RENAL & BLADDER: History of clinically significant cardiovascular disease including, but not limited to:
  • Myocardial infarction or unstable angina =< 6 months prior to treatment initiation
  • Clinically significant cardiac arrhythmia
  • Deep vein thrombosis, pulmonary embolism, stroke =< 6 months prior to treatment initiation
  • Congestive heart failure (New York Heart Association class III-IV)
  • Pericarditis/clinically significant pericardial effusion
  • Myocarditis
  • Endocarditis
  • RENAL & BLADDER: Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) =< 2 years prior to enrollment
  • RENAL & BLADDER: Any condition that in the opinion of the investigator, would preclude participation in this study
  • RENAL & BLADDER: Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]); subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels; those who are PCR positive will be excluded; EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (antiHBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR; seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)

Contact:

  • Matthew Campbell, MD
  • 713-792-2830

Location:

  • M D Anderson Cancer Center
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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A Phase II of Single Agent Cabozantinib in Patients With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma Post Immunotherapy or Who Are Unsuitable for Immunotherapy (ANZUP1802)


Condition: Renal Cell Carcinoma, Papillary Renal Cell Carcinoma Type 1, Papillary Renal Cell Carcinoma Type 2, Chromophobe Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Xp11.2 Translocation-Related Renal Cell Carcinoma

Intervention:

  • Drug: Cabozantinib

Purpose: Renal cell carcinoma (RCC) is the 9th most common cancer in Australia, the 10th most common cancer in Western populations.~75% of kidney cancers are clear-cell renal cell carcinomas (ccRCC). Many patients present with advanced or unresectable disease at diagnosis and a number of treatments are now available for metastatic ccRCC included vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs), mTOR inhibitors, and cytokines. More recently first line use of immunotherapy demonstrated improved survival with checkpoint inhibitors. While many patients benefit from first-line treatment, progression is inevitable and these treatments remain on the whole palliative. Second-line VEGFR TKIs, mTOR inhibitors and immunotherapy have some benefit but in a smaller increment than first-line treatment. While ~75% of kidney cancers are the clear-cell variant, ~25% of kidney cancers are non-clear cell histology (nccRCC) and include papillary, chromophobe, sarcomatoid, collecting duct carcinoma, Xp11 translocation carcinoma and unclassified. Patients with non-ccRCC have significantly lower response rates and poorer median progression-free survival and overall survival than those with ccRCC. Non clear cell histologies have largely been excluded from large phase III randomised clinical trials and therefore the optimal treatment and sequencing of therapies for these patients remains unclear. Despite recent unprecedented advances in treatment, there continues to be an unmet need to improve outcomes for patients with previously untreated, unresectable or metastatic renal cell carcinoma. This is particularly relevant in non-clear cell RCC. Because it is a rarer subtype of metastatic renal cell carcinoma, it is more challenging to study, and treatment efficacy data is sparse. The research project is testing a new treatment for participants with locally advanced or metastatic non-clear cell kidney cancer. The new treatment involves a drug called Cabozantinib (also known as Cabometyx). This drug has been used previously in many cancers, including clear cell kidney cancer and thyroid cancer. The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of Cabozantinib. Cabozantinib is a anti-cancer drug that works by blocking cancer cell growth. It blocks particular proteins called protein kinases on cancer cells. Protein kinases encourage the cancer to grow. Cabozantinib is called a multi kinase inhibitor because it blocks a number of these proteins. How well cabozantinib works in cancer of the kidney will be tested by measuring the change in size of your tumours that are seen on CT scans. Cabozantinib is approved to treat clear cell kidney cancer and thyroid cancer in Australia. It has not been tested in people with non-clear cell kidney cancer. About 48 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia. Even though this study may be suitable for you, it is possible that you may not be enrolled in this study. This research study has been initiated by Dr. David Pook, is being conducted in collaboration with the Centre for Biostatistics and Clinical Trials (BaCT) and sponsored in Australia by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group Pty Ltd. Ipsen is supplying

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03685448

Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Primary Outcome Measures:

  • Measure: The objective response rate (ORR), as assessed by RECIST 1.1.
  • Time Frame: Through study completion, on average 2 years.
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: The number of participants with adverse events that are related to study drug, as assessed and graded by CTCAE v5.0.
  • Time Frame: From time of patient registration, until 30 days after the last dose of treatment.
  • Safety Issue:
  • Measure: Progression-free survival (PFS), as assessed by RECIST1.1.
  • Time Frame: Through study completion, on average 2 years.
  • Safety Issue:
  • Measure: The number of patients alive at the end of the study, as assessed by date of death. Overall survival (OS) is defined as the time between the date of registration to part 1 of the study and the date of death due to any cause.
  • Time Frame: Through study completion, on average 5 years.
  • Safety Issue:

Estimated Enrollment: 48

Study Start Date: April 11, 2019

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histologically confirmed un-resectable, locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic non-clear cell renal cell histology (comprising greater than 50% of the tumour) including: 1. Papillary renal cell carcinoma (type 1) 2. Papillary renal cell carcinoma (type 2) 3. Other subtypes: including chromophobe renal cell carcinoma, sarcomatoid renal cell carcinoma, Xp11 translocation (TFE3+ IHC) carcinoma, other renal carcinoma NOS
  • Patient is either; 1. Ineligible for checkpoint inhibitor immunotherapy due to pre-existing autoimmune disorder in the opinion of the investigator, or 2. Has progressed following treatment with checkpoint inhibitor immunotherapy
  • Be greater than 18 years of age on the day of signing informed consent
  • At least 1 target lesion according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (refer to Appendix 1)
  • Adequate bone marrow function (performed within 14 days prior to registration and with values within the ranges specified below): 1. Haemoglobin ≥ 90g/L 2. Platelets ≥ 100x109/L 3. Neutrophil count ≥ 1.5x109/L
  • Adequate liver function (performed within 14 days prior to registration and with values within the ranges specified below): 1. Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for participants with known Gilbert's syndrome who can have total bilirubin < 3.0 mg/dL 2. AST or ALT ≤ 3.0 x ULN (or ≤ 5.0x ULN in the presence of liver metastases)
  • Adequate renal function (performed within 14 days prior to registration and with values within the ranges specified below): 1. Creatinine ≤ 1.5x ULN, or 2. Creatinine clearance (CrCl) ≥ 30mL/min (use Cockcroft-Gault Formula, refer to Appendix 2) 3. Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine or 24-hour urine protein <1 g.
  • Negative pregnancy test for female participants of childbearing potential within 72 hours prior to registration. If urine test cannot be confirmed as negative, a negative serum pregnancy test is required.
  • Female participants of childbearing potential must be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for greater than 1 year.
  • Male participants with sexual partners of childbearing age must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • Able to provide a formalin-fixed paraffin embedded (FFPE) tumour block, representative of the participant's primary or metastatic disease (preferred), which must be forwarded to the Centre for Biostatistics and Clinical Trials (BaCT) within 10 working days post registration (if not previously collected for the UNISoN study).
  • Willing and able to start treatment within 14 days of registration, and to comply with all study requirements, including the timing and/or nature of the required treatment and assessments
  • Has provided signed, written informed consent.

Exclusion Criteria:

  • Patients with urothelial or transitional cell carcinoma of the renal pelvis or ureter
  • Predominant clear cell renal cell carcinoma. A minority of clear cell histology (<50%) is acceptable, but there must be >50% non-clear cell histology predominant.
  • Participation in a study of an investigational agent within 30 days of registration.
  • Untreated brain or leptomeningeal metastases or current clinical or radiological progression of known brain metastases or requirement for steroid therapy for brain metastases. Participants with treated brain metastases are eligible if metastases have been shown to be stable on repeat imaging post treatment and steroid treatment has been ceased for ≥ 3 weeks.
  • Serious Cardiovascular disorders: 1. Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias. 2. Uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment. 3. Stroke (including TIA), myocardial infarction, or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before randomization.
  • Active infection requiring systemic therapy within 14 days before registration.
  • Life expectancy of less than 3 months.
  • Prior systemic therapy, surgery or radiation therapy within 4 weeks before registation. Note: If the participant has undergone major surgery, complete wound healing must have occurred 1 month prior to registration. Patients must not have received prior targeted therapy or chemotherapy, but may have received previous checkpoint immunotherapy, for example, via the UNISoN trial (NCT03177239)
  • History of another active malignancy except for locally curable cancers that have been apparently cured, such as low-grade thyroid carcinoma, prostate cancer not requiring treatment (Gleason grade ≤ 6), basal or squamous cell skin cancer, superficial bladder cancer, melanoma in situ or carcinoma in situ of the prostate, cervix, or breast. Participants who have been treated for other malignancies and have a <5% chance of relapse according to the investigator are eligible for this study.
  • Active hepatitis B virus infection indicated by positive Hepatitis B surface antigen (HBVsAg) or active Hepatitis C infection indicated by antibodies to hepatitis C virus ribonucleic acid (HCV antibody). Patients with undetectable viral load indicating cure in the presence of HBVsAg or HCV antibodies are eligible.
  • A history of other significant infection, including HIV. HIV testing is not mandatory unless clinically indicated.
  • Participants should be excluded if they have a history of allergy to study drug components, or a history of severe hypersensitivity reaction to any monoclonal antibody.
  • Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
  • Patient is pregnant or breastfeeding.

Contact:

  • Laura Galletta, BSc
  • + 61 8559 7529

Locations:

  • Border Medical Oncology Research Unit / The Border Cancer Hospital
  • Albury New South Wales 2460 Australia
  • Campbelltown Hospital
  • Campbelltown New South Wales 2560 Australia
  • St George Hospital
  • Kogarah New South Wales Australia
  • Macquarie University Hospital
  • Macquarie Park New South Wales 2109 Australia
  • Calvary Mater Newcastle
  • Newcastle New South Wales Australia
  • Northern Cancer Institute
  • St Leonards New South Wales Australia
  • Royal Brisbane & Women's Hospital
  • Herston Queensland Australia
  • Flinders Medical Centre
  • Bedford Park South Australia 5042 Australia
  • Adelaide Cancer Centre / Ashford Cancer Centre Research / Cancer Care SA
  • Kurralta Park South Australia 5037 Australia
  • Box Hill Hospital - Eastern Health
  • Box Hill Victoria 3128 Australia
  • Monash Medical Centre
  • Clayton Victoria Australia

View trial on ClinicalTrials.gov


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Advanced MRI in Renal Tumors.


Condition: Renal Cell Carcinoma

Intervention:

  • Device: Magnetic Resonance Imaging

Purpose: Diagnostic imaging for renal masses of unknown nature using conventional imaging modalities such as 3 phase contrast-enhanced computed tomography (CT) is not always conclusive. After (partial) nephrectomy, 10-20 % of the resected tumors show benign histology which could not be identified on diagnostic imaging. With improved imaging techniques available, leading to improvements in characterisation of renal tumors, the number of unnecessary resections may be reduced. The objective of this study is to evaluate the diagnostic performance of diffusion weighted magnetic resonance imaging (DW-MRl) in assessing the nature of renal masses, including the use of diffusion tensor imaging (DTI).Therefore patients >18 years of age scheduled for undergoing (partial) tumor nephrectomy will undergo one additional MRI examination.

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02325921

Sponsor: Radboud University

Primary Outcome Measures:

  • Measure: Discriminating malignant from benign lesions using Apparent Diffusion Coefficient (ADC) values, a metric obtained by diffusion weighted MRI.
  • Time Frame: 12 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: To distinguish histological subtypes of renal tumors using Apparent Diffusion Coefficient (ADC), mean diffusivity and Fractional Anisotropy (FA) values, metrics obtained by Diffusion Tensor Imaging (DTI).
  • Time Frame: 12 months
  • Safety Issue:

Estimated Enrollment: 80

Study Start Date: October 2014

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Planned to undergo (partial) tumor nephrectomy of at least one untreated tumor of one kidney;
  • Signed Institutional Review Board (IRB) approved informed consent form.

Exclusion Criteria:

  • Relative contra indications for MRI (metal device/foreign bodies, claustrophobia);
  • Active renal or perirenal infection;
  • Minor and/or incapacitated adult.

Contact:

  • Tim J. van Oostenbrugge, MD
  • 0031243619097

Location:

  • Radboud University Medical Center
  • Nijmegen 6500HB Netherlands

View trial on ClinicalTrials.gov


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A Phase II Randomized, Open Label Study of High Dose Interleukin 2 vs High Dose Interleukin 2 Plus Entinostat in Advanced Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Intervention:

  • Drug: Entinostat
  • Drug: Interleukin-2

Purpose: This is a multicenter, randomized, open label study of high dose interleukin 2 vs high dose interleukin 2 plus entinostat in clear cell RCC patients who are candidate for high dose interleukin 2. Patients will be randomized to ARM 1 (high dose interleukin 2 plus entinostat) or ARM 2 (high dose interleukin 2). Subjects will receive 2 treatments of high dose interleukin 600,000 units/kg administered IV every 8 hrs on Days 1-5 and Days 15-19 (maximum 28 doses) +/- entinostat 5 mg orally given every 2 weeks starting on Day-14, continuously. Tumor response assessment will be performed between HD IL-2 courses.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03501381

Sponsor: Roberto Pili

Primary Outcome Measures:

  • Measure: Progression Free Survival (PFS)
  • Time Frame: 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Objective Response Rate
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Assess Adverse Events
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Duration of response
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Overall Survival
  • Time Frame: 24 Months
  • Safety Issue:

Estimated Enrollment: 46

Study Start Date: May 24, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Age ≥ 18 years at the time of consent.
  • ECOG Performance Status of 0 within 7 days prior to registration.
  • Life expectancy of greater than 6 months.
  • Patients must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically unresectable. The histology must be clear cell carcinoma or predominant clear cell carcinoma.
  • Patients must have measurable or evaluable disease by RECIST 1.1.
  • Up to two prior therapies for RCC are allowed. One prior therapy must contain an immune checkpoint inhibitor.Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
  • White blood cell (WBC) ≥ 3,000 K/mm3
  • Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
  • Leukocytes ≥ 3,000/mm3
  • Platelets ≥ 100,000/mm3
  • Hemoglobin (Hgb) ≥ 12 g/dL
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
  • Calculated creatinine clearance ≥ 50 mL/min
  • Corrected calcium ≤ 10 mg/dL
  • Urine protein < 1 +; if ≥ 1+, a 24 hour urine protein should be obtained and be < 1,000 mg
  • Total Bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) ≤ 2.5 × ULN
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN
  • Lactate Dehydrogenase Within Normal Limits
  • International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN
  • Females of childbearing potential must have a negative serum pregnancy test during screening and within 3 days prior to receiving first dose of study medication. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months.
  • Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 90days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.
  • Pulmonary: FEV1 > 2.0 liters or > 75% of predicted for height and age
  • Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina. NOTE: Patients who are over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemia.
  • CNS: No history of cerebrovascular accident, transient ischemic attacks, central nervous system or brain metastases. NOTE: Patients with CNS metastases should have a head CT/MRI within 21 days prior to treatment initiation. Any imaging abnormality indicative of CNS metastases will exclude the patient from the study. Patients with previously excised/gamma knifed solitary or oligometastases and no evidence of recurrent disease for 6 months are eligible.

Exclusion Criteria:

  • Concurrent use of valproic acid use is not allowed.
  • Receiving medications that can effect clotting ability: warfarin, aspirin (once-daily aspirin use- maximum dose 325 mg/day is permitted), nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents.
  • Patients may not be receiving other investigational agents.
  • Active infection requiring systemic therapy
  • Pregnant or breastfeeding
  • Any prior history of other cancer within the prior 5 years with the exception of adequately treated basal cell carcinoma, cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ, melanoma in situ or ductal carcinoma in situ [DCIS], localized Gleason 6 prostate cancer, papillary thyroid cancer or other non-melanoma skin cancers.
  • Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association Class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (< the last 6 months), cardiac arrhythmia, history of CVA within 6 months, hypertension (defined as blood pressure of >160 mmHg systolic and/or >90 mmHg diastolic on medication), QTc interval > 470 msec, history of peripheral vascular disease, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study
  • HIV-positive patients receiving combination antiretroviral therapy are are eligible if their HIV is well-controlled (undetectable VL and CD4 count >350) and they are on anti-retrovirals unlikely to interact with entinostat.
  • Known active hepatitis B (e.g., hepatitis B surface antigen-reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative]). Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible. NOTE: HBV DNA test must be performed prior to study treatment. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Serious or non-healing wound, ulcer or bone fracture.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 therapy.
  • Anticipation of need for major surgical procedures during the course of the study.
  • Left ventricular ejection function < 45%.

Contact:

  • Roberto Pili, MD
  • 317-944-3684

Locations:

  • Indiana Univeristy Melvin and Bren Simon Cancer Center
  • Indianapolis Indiana 46202 United States
  • Hematology Oncology Clinic, LLC
  • Baton Rouge Louisiana 70809 United States
  • Nebraska Methodist Hospital
  • Omaha Nebraska 68114 United States

View trial on ClinicalTrials.gov


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PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE]


Condition: Clear Cell Renal Cell Carcinoma, Metastatic Malignant Neoplasm in Lymph Node, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Soft Tissues, Metastatic Malignant Neoplasm in the Viscera, Sarcomatoid Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8

Intervention:

  • Drug: Cabozantinib
  • Biological: Ipilimumab
  • Biological: Nivolumab
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Purpose: This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03793166

Sponsor: National Cancer Institute (NCI)

Primary Outcome Measures:

  • Measure: Overall survival (OS)
  • Time Frame: From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression-free survival (PFS)
  • Time Frame: From date of registration to date of progression or death from any cause, whichever occurs first, assessed up to 5 years
  • Safety Issue:
  • Measure: Complete response (CR) (randomized patients)
  • Time Frame: At 12 months from date of randomization
  • Safety Issue:
  • Measure: Objective response
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Proportion of patients who discontinue protocol-directed treatment prior to 1 year from date of study registration
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: Incidence of adverse events
  • Time Frame: Up to 5 years
  • Safety Issue:

Estimated Enrollment: 1046

Study Start Date: May 9, 2019

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • STEP I REGISTRATION CRITERIA
  • Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features.
  • Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1.
  • Measurable disease as defined.
  • Intermediate or poor risk patients per International Metastatic Renal Cell Carcinoma Database (IMDC) criteria will be eligible (1 or more of the following: Karnofsky performance status (KPS) < 80, < 1 year from diagnosis to systemic treatment, hemoglobin less than lower limit of normal (LLN), corrected calcium concentration greater than upper limit of normal [ULN], absolute neutrophil count greater than ULN, platelet count > ULN).
  • Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment.
  • Karnofsky performance status >= 70%.
  • No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab, tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways.
  • No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 [> 28 days] and prior adjuvant sunitinib > 180 days since completion are allowed).
  • No cancer therapy less than 28 days prior to registration; this includes radiation therapy, except for bone lesions less than 14 days prior to registration. There must be a complete recovery and no ongoing complications from radiotherapy.
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 14 days prior to registration is required.
  • None of the following:
  • Active autoimmune disease requiring ongoing therapy.
  • Ongoing acute toxicity > grade 2 from previous treatment.
  • History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies.
  • History of human immunodeficiency virus (HIV) or active hepatitis B/C, or tuberculosis.
  • Concurrent use of immunosuppressive medication including prednisone above 10 mg daily.
  • Uncontrolled adrenal insufficiency.
  • Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg or diastolic BP > 90 mmHg).
  • Major surgery less than 28 days prior to registration.
  • Any serious non-healing wound, ulcer, or bone fracture within 28 days prior to registration.
  • Any arterial thrombotic events within 180 days prior to registration.
  • Clinically significant hematuria, hematemesis, or hemoptysis within 12 weeks prior to registration.
  • Cavitating pulmonary lesions or known endotracheal or endobronchial disease manifestations.
  • Lesions encasing or invading any major blood vessels.
  • Moderate of severe hepatic impairment (child-Pugh B or C).
  • Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) in the 180 days prior to registration. (Any asymptomatic, treated pulmonary embolism or asymptomatic, treated deep venous thrombosis > 30 days prior to registration allowed).
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms.
  • Unstable cardiac arrhythmia within 6 months prior to registration.
  • Any gastrointestinal (GI) bleeding =< 180 days, hemoptysis, or other signs of pulmonary hemorrhage =< 90 days prior to registration.
  • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration.
  • Active peptic ulcer disease, inflammatory bowel disease, or malabsorption syndrome within 28 days prior to registration.
  • Untreated hypothyroidism, evidence of pancreatitis, history of organ transplant, or history of congenital QT syndrome.
  • Active treatment with warfarin or any oral factor Xa inhibitors (treatment with low molecular weight heparin [LMWH] is allowed).
  • Absolute neutrophil count (ANC) >= 1,500/mm^3.
  • Platelet Count >= 100,000/mm^3.
  • Hemoglobin >= 8 g/d.
  • Calculated (Calc.) creatinine clearance >= 30 mL/min.
  • Urine protein =< 1+ or urine protein to creatinine (UPC) ratio < 1.
  • Total Bilirubin =< 1.5 x upper limit of normal (ULN).
  • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 2.5 x upper limit of normal (ULN) or < 5 x ULN if hepatic metastases present.
  • Creatine kinase MB (CK-MB) and troponin =< upper limit of normal (ULN).
  • STEP 2 REGISTRATION

Eligibility Criteria:

  • Successful completion of at least 1 cycle of ipilimumab/nivolumab.
  • Resolution of any treatment-related adverse events to grade 1 or less per dose modification section.
  • No more than 56 days from last dose of ipilimumab/nivolumab.

Locations:

  • Anchorage Associates in Radiation Medicine
  • Anchorage Alaska 98508 United States
  • Anchorage Radiation Therapy Center
  • Anchorage Alaska 99504 United States
  • Alaska Breast Care and Surgery LLC
  • Anchorage Alaska 99508 United States
  • Alaska Oncology and Hematology LLC
  • Anchorage Alaska 99508 United States
  • Alaska Women's Cancer Care
  • Anchorage Alaska 99508 United States
  • Anchorage Oncology Centre
  • Anchorage Alaska 99508 United States
  • Katmai Oncology Group
  • Anchorage Alaska 99508 United States
  • Providence Alaska Medical Center
  • Anchorage Alaska 99508 United States
  • Kingman Regional Medical Center
  • Kingman Arizona 86401 United States
  • Mercy Hospital Fort Smith
  • Fort Smith Arkansas 72903 United States
  • CHI Saint Vincent Cancer Center Hot Springs
  • Hot Springs Arkansas 71913 United States
  • PCR Oncology
  • Arroyo Grande California 93420 United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Burbank California 91505 United States
  • Rocky Mountain Cancer Centers-Aurora
  • Aurora Colorado 80012 United States
  • The Medical Center of Aurora
  • Aurora Colorado 80012 United States
  • Boulder Community Hospital
  • Boulder Colorado 80301 United States
  • Rocky Mountain Cancer Centers-Boulder
  • Boulder Colorado 80304 United States
  • Penrose-Saint Francis Healthcare
  • Colorado Springs Colorado 80907 United States
  • Rocky Mountain Cancer Centers-Penrose
  • Colorado Springs Colorado 80907 United States
  • National Jewish Health-Main Campus
  • Denver Colorado 80206 United States
  • The Women's Imaging Center
  • Denver Colorado 80209 United States
  • Porter Adventist Hospital
  • Denver Colorado 80210 United States
  • Colorado Blood Cancer Institute
  • Denver Colorado 80218 United States
  • Presbyterian - Saint Lukes Medical Center - Health One
  • Denver Colorado 80218 United States
  • Rocky Mountain Cancer Centers-Midtown
  • Denver Colorado 80218 United States
  • SCL Health Saint Joseph Hospital
  • Denver Colorado 80218 United States
  • Rocky Mountain Cancer Centers-Rose
  • Denver Colorado 80220 United States
  • Rose Medical Center
  • Denver Colorado 80220 United States
  • Western Surgical Care
  • Denver Colorado 80220 United States
  • Mercy Medical Center
  • Durango Colorado 81301 United States
  • Southwest Oncology PC
  • Durango Colorado 81301 United States
  • Comprehensive Cancer Care and Research Institute of Colorado LLC
  • Englewood Colorado 80113 United States
  • Swedish Medical Center
  • Englewood Colorado 80113 United States
  • National Jewish Health-Western Hematology Oncology
  • Golden Colorado 80401 United States
  • Saint Mary's Hospital and Regional Medical Center
  • Grand Junction Colorado 81501 United States
  • North Colorado Medical Center
  • Greeley Colorado 80631 United States
  • Good Samaritan Medical Center
  • Lafayette Colorado 80026 United States
  • Saint Anthony Hospital
  • Lakewood Colorado 80228 United States
  • Rocky Mountain Cancer Centers-Littleton
  • Littleton Colorado 80120 United States
  • Littleton Adventist Hospital
  • Littleton Colorado 80122 United States
  • Rocky Mountain Cancer Centers-Sky Ridge
  • Lone Tree Colorado 80124 United States
  • Sky Ridge Medical Center
  • Lone Tree Colorado 80124 United States
  • Longmont United Hospital
  • Longmont Colorado 80501 United States
  • Rocky Mountain Cancer Centers-Longmont
  • Longmont Colorado 80501 United States
  • McKee Medical Center
  • Loveland Colorado 80539 United States
  • Parker Adventist Hospital
  • Parker Colorado 80138 United States
  • Saint Mary Corwin Medical Center
  • Pueblo Colorado 81004 United States
  • National Jewish Health-Northern Hematology Oncology
  • Thornton Colorado 80260 United States
  • SCL Health Lutheran Medical Center
  • Wheat Ridge Colorado 80033 United States
  • Stamford Hospital/Bennett Cancer Center
  • Stamford Connecticut 06904 United States
  • UF Cancer Center at Orlando Health
  • Orlando Florida 32806 United States
  • Saint Alphonsus Cancer Care Center-Boise
  • Boise Idaho 83706 United States
  • Saint Luke's Mountain States Tumor Institute
  • Boise Idaho 83712 United States
  • Saint Alphonsus Cancer Care Center-Caldwell
  • Caldwell Idaho 83605 United States
  • Kootenai Medical Center
  • Coeur d'Alene Idaho 83814 United States
  • Walter Knox Memorial Hospital
  • Emmett Idaho 83617 United States
  • Saint Luke's Mountain States Tumor Institute - Fruitland
  • Fruitland Idaho 83619 United States
  • Idaho Urologic Institute-Meridian
  • Meridian Idaho 83642 United States
  • Saint Luke's Mountain States Tumor Institute - Meridian
  • Meridian Idaho 83642 United States
  • Saint Alphonsus Medical Center-Nampa
  • Nampa Idaho 83686 United States
  • Saint Luke's Mountain States Tumor Institute - Nampa
  • Nampa Idaho 83686 United States
  • Kootenai Cancer Center
  • Post Falls Idaho 83854 United States
  • Kootenai Cancer Clinic
  • Sandpoint Idaho 83864 United States
  • Saint Luke's Mountain States Tumor Institute-Twin Falls
  • Twin Falls Idaho 83301 United States
  • Rush - Copley Medical Center
  • Aurora Illinois 60504 United States
  • Illinois CancerCare-Bloomington
  • Bloomington Illinois 61704 United States
  • Illinois CancerCare-Canton
  • Canton Illinois 61520 United States
  • Memorial Hospital of Carbondale
  • Carbondale Illinois 62902 United States
  • SIH Cancer Institute
  • Carterville Illinois 62918 United States
  • Illinois CancerCare-Carthage
  • Carthage Illinois 62321 United States
  • Centralia Oncology Clinic
  • Centralia Illinois 62801 United States
  • University of Chicago Comprehensive Cancer Center
  • Chicago Illinois 60637 United States
  • Carle on Vermilion
  • Danville Illinois 61832 United States
  • Cancer Care Specialists of Illinois - Decatur
  • Decatur Illinois 62526 United States
  • Decatur Memorial Hospital
  • Decatur Illinois 62526 United States
  • Carle Physician Group-Effingham
  • Effingham Illinois 62401 United States
  • Crossroads Cancer Center
  • Effingham Illinois 62401 United States
  • Illinois CancerCare-Eureka
  • Eureka Illinois 61530 United States
  • Illinois CancerCare-Galesburg
  • Galesburg Illinois 61401 United States
  • Western Illinois Cancer Treatment Center
  • Galesburg Illinois 61401 United States
  • Illinois CancerCare-Kewanee Clinic
  • Kewanee Illinois 61443 United States
  • Illinois CancerCare-Macomb
  • Macomb Illinois 61455 United States
  • Carle Physician Group-Mattoon/Charleston
  • Mattoon Illinois 61938 United States
  • Good Samaritan Regional Health Center
  • Mount Vernon Illinois 62864 United States
  • UC Comprehensive Cancer Center at Silver Cross
  • New Lenox Illinois 60451 United States
  • University of Chicago Medicine-Orland Park
  • Orland Park Illinois 60462 United States
  • Illinois CancerCare-Ottawa Clinic
  • Ottawa Illinois 61350 United States
  • Illinois CancerCare-Pekin
  • Pekin Illinois 61554 United States
  • Illinois CancerCare-Peoria
  • Peoria Illinois 61615 United States
  • Methodist Medical Center of Illinois
  • Peoria Illinois 61636 United States
  • Illinois CancerCare-Peru
  • Peru Illinois 61354 United States
  • Valley Radiation Oncology
  • Peru Illinois 61354 United States
  • Illinois CancerCare-Princeton
  • Princeton Illinois 61356 United States
  • Southern Illinois University School of Medicine
  • Springfield Illinois 62702 United States
  • Springfield Clinic
  • Springfield Illinois 62702 United States
  • Memorial Medical Center
  • Springfield Illinois 62781 United States
  • Cancer Care Specialists of Illinois-Swansea
  • Swansea Illinois 62226 United States
  • Southwest Illinois Health Services LLP
  • Swansea Illinois 62226 United States
  • Carle Cancer Center
  • Urbana Illinois 61801 United States
  • The Carle Foundation Hospital
  • Urbana Illinois 61801 United States
  • Rush-Copley Healthcare Center
  • Yorkville Illinois 60560 United States
  • Mary Greeley Medical Center
  • Ames Iowa 50010 United States
  • McFarland Clinic PC - Ames
  • Ames Iowa 50010 United States
  • McFarland Clinic PC-Boone
  • Boone Iowa 50036 United States
  • Medical Oncology and Hematology Associates-West Des Moines
  • Clive Iowa 50325 United States
  • Mercy Cancer Center-West Lakes
  • Clive Iowa 50325 United States
  • Alegent Health Mercy Hospital
  • Council Bluffs Iowa 51503 United States
  • Iowa Methodist Medical Center
  • Des Moines Iowa 50309 United States
  • Medical Oncology and Hematology Associates-Des Moines
  • Des Moines Iowa 50309 United States
  • Broadlawns Medical Center
  • Des Moines Iowa 50314 United States
  • Medical Oncology and Hematology Associates-Laurel
  • Des Moines Iowa 50314 United States
  • Mercy Medical Center - Des Moines
  • Des Moines Iowa 50314 United States
  • Iowa Lutheran Hospital
  • Des Moines Iowa 50316 United States
  • McFarland Clinic PC-Trinity Cancer Center
  • Fort Dodge Iowa 50501 United States
  • Trinity Regional Medical Center
  • Fort Dodge Iowa 50501 United States
  • McFarland Clinic PC-Jefferson
  • Jefferson Iowa 50129 United States
  • McFarland Clinic PC-Marshalltown
  • Marshalltown Iowa 50158 United States
  • Methodist West Hospital
  • West Des Moines Iowa 50266-7700 United States
  • Mercy Medical Center-West Lakes
  • West Des Moines Iowa 50266 United States
  • Central Care Cancer Center - Garden City
  • Garden City Kansas 67846 United States
  • Central Care Cancer Center - Great Bend
  • Great Bend Kansas 67530 United States
  • Kansas Institute of Medicine Cancer and Blood Center
  • Lenexa Kansas 66219 United States
  • Minimally Invasive Surgery Hospital
  • Lenexa Kansas 66219 United States
  • Menorah Medical Center
  • Overland Park Kansas 66209 United States
  • Flaget Memorial Hospital
  • Bardstown Kentucky 40004 United States
  • Commonwealth Cancer Center-Corbin
  • Corbin Kentucky 40701 United States
  • Saint Joseph Radiation Oncology Resource Center
  • Lexington Kentucky 40504 United States
  • Saint Joseph Hospital East
  • Lexington Kentucky 40509 United States
  • Saint Joseph London
  • London Kentucky 40741 United States
  • Jewish Hospital
  • Louisville Kentucky 40202 United States
  • Saints Mary and Elizabeth Hospital
  • Louisville Kentucky 40215 United States
  • Jewish Hospital Medical Center Northeast
  • Louisville Kentucky 40245 United States
  • Jewish Hospital Medical Center South
  • Shepherdsville Kentucky 40165 United States
  • LSU Health Baton Rouge-North Clinic
  • Baton Rouge Louisiana 70805 United States
  • Louisiana Hematology Oncology Associates LLC
  • Baton Rouge Louisiana 70809 United States
  • Mary Bird Perkins Cancer Center
  • Baton Rouge Louisiana 70809 United States
  • Our Lady of the Lake Physicians Group - Medical Oncology
  • Baton Rouge Louisiana 70809 United States
  • Northshore Oncology Associates-Covington
  • Covington Louisiana 70433 United States
  • Oncology Center of The South Incorporated
  • Houma Louisiana 70360 United States
  • Hickman Cancer Center
  • Adrian Michigan 49221 United States
  • Green Bay Oncology - Escanaba
  • Escanaba Michigan 49829 United States
  • Toledo Clinic Cancer Centers-Monroe
  • Monroe Michigan 48162 United States
  • Huron Medical Center PC
  • Port Huron Michigan 48060 United States
  • Lake Huron Medical Center
  • Port Huron Michigan 48060 United States
  • Sanford Joe Lueken Cancer Center
  • Bemidji Minnesota 56601 United States
  • Essentia Health Saint Joseph's Medical Center
  • Brainerd Minnesota 56401 United States
  • Fairview Ridges Hospital
  • Burnsville Minnesota 55337 United States
  • Cambridge Medical Center
  • Cambridge Minnesota 55008 United States
  • Mercy Hospital
  • Coon Rapids Minnesota 55433 United States
  • Essentia Health - Deer River Clinic
  • Deer River Minnesota 56636 United States
  • Essentia Health Saint Mary's - Detroit Lakes Clinic
  • Detroit Lakes Minnesota 56501 United States
  • Essentia Health Cancer Center
  • Duluth Minnesota 55805 United States
  • Essentia Health Saint Mary's Medical Center
  • Duluth Minnesota 55805 United States
  • Miller-Dwan Hospital
  • Duluth Minnesota 55805 United States
  • Fairview-Southdale Hospital
  • Edina Minnesota 55435 United States
  • Lake Region Healthcare Corporation-Cancer Care
  • Fergus Falls Minnesota 56537 United States
  • Essentia Health - Fosston
  • Fosston Minnesota 56542 United States
  • Unity Hospital
  • Fridley Minnesota 55432 United States
  • Essentia Health Hibbing Clinic
  • Hibbing Minnesota 55746 United States
  • Fairview Maple Grove Medical Center
  • Maple Grove Minnesota 55369 United States
  • Minnesota Oncology Hematology PA-Maplewood
  • Maplewood Minnesota 55109 United States
  • Saint John's Hospital - Healtheast
  • Maplewood Minnesota 55109 United States
  • Abbott-Northwestern Hospital
  • Minneapolis Minnesota 55407 United States
  • Hennepin County Medical Center
  • Minneapolis Minnesota 55415 United States
  • Health Partners Inc
  • Minneapolis Minnesota 55454 United States
  • Monticello Cancer Center
  • Monticello Minnesota 55362 United States
  • New Ulm Medical Center
  • New Ulm Minnesota 56073 United States
  • Essentia Health - Park Rapids
  • Park Rapids Minnesota 56470 United States
  • Fairview Northland Medical Center
  • Princeton Minnesota 55371 United States
  • North Memorial Medical Health Center
  • Robbinsdale Minnesota 55422 United States
  • Coborn Cancer Center at Saint Cloud Hospital
  • Saint Cloud Minnesota 56303 United States
  • Park Nicollet Clinic - Saint Louis Park
  • Saint Louis Park Minnesota 55416 United States
  • Regions Hospital
  • Saint Paul Minnesota 55101 United States
  • United Hospital
  • Saint Paul Minnesota 55102 United States
  • Essentia Health Sandstone
  • Sandstone Minnesota 55072 United States
  • Saint Francis Regional Medical Center
  • Shakopee Minnesota 55379 United States
  • Lakeview Hospital
  • Stillwater Minnesota 55082 United States
  • Sanford Thief River Falls Medical Center
  • Thief River Falls Minnesota 56701 United States
  • Essentia Health Virginia Clinic
  • Virginia Minnesota 55792 United States
  • Ridgeview Medical Center
  • Waconia Minnesota 55387 United States
  • Rice Memorial Hospital
  • Willmar Minnesota 56201 United States
  • Minnesota Oncology Hematology PA-Woodbury
  • Woodbury Minnesota 55125 United States
  • Sanford Cancer Center Worthington
  • Worthington Minnesota 56187 United States
  • Fairview Lakes Medical Center
  • Wyoming Minnesota 55092 United States
  • University of Mississippi Medical Center
  • Jackson Mississippi 39216 United States
  • Saint Louis Cancer and Breast Institute-Ballwin
  • Ballwin Missouri 63011 United States
  • Central Care Cancer Center - Bolivar
  • Bolivar Missouri 65613 United States
  • Parkland Health Center-Bonne Terre
  • Bonne Terre Missouri 63628 United States
  • Cox Cancer Center Branson
  • Branson Missouri 65616 United States
  • Saint Francis Medical Center
  • Cape Girardeau Missouri 63703 United States
  • Southeast Cancer Center
  • Cape Girardeau Missouri 63703 United States
  • Centerpoint Medical Center LLC
  • Independence Missouri 64057 United States
  • Capital Region Southwest Campus
  • Jefferson City Missouri 65109 United States
  • Freeman Health System
  • Joplin Missouri 64804 United States
  • Mercy Hospital Joplin
  • Joplin Missouri 64804 United States
  • Research Medical Center
  • Kansas City Missouri 64132 United States
  • Delbert Day Cancer Institute at PCRMC
  • Rolla Missouri 65401 United States
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Rolla Missouri 65401 United States
  • Heartland Regional Medical Center
  • Saint Joseph Missouri 64507 United States
  • Saint Louis Cancer and Breast Institute-South City
  • Saint Louis Missouri 63109 United States
  • Mercy Hospital South
  • Saint Louis Missouri 63128 United States
  • Missouri Baptist Medical Center
  • Saint Louis Missouri 63131 United States
  • Mercy Hospital Saint Louis
  • Saint Louis Missouri 63141 United States
  • Sainte Genevieve County Memorial Hospital
  • Sainte Genevieve Missouri 63670 United States
  • Mercy Hospital Springfield
  • Springfield Missouri 65804 United States
  • CoxHealth South Hospital
  • Springfield Missouri 65807 United States
  • Missouri Baptist Sullivan Hospital
  • Sullivan Missouri 63080 United States
  • Missouri Baptist Outpatient Center-Sunset Hills
  • Sunset Hills Missouri 63127 United States
  • Mercy Hospital Washington
  • Washington Missouri 63090 United States
  • Community Hospital of Anaconda
  • Anaconda Montana 59711 United States
  • Billings Clinic Cancer Center
  • Billings Montana 59101 United States
  • Saint Vincent Healthcare
  • Billings Montana 59101 United States
  • Saint Vincent Frontier Cancer Center
  • Billings Montana 59102 United States
  • Bozeman Deaconess Hospital
  • Bozeman Montana 59715 United States
  • Saint James Community Hospital and Cancer Treatment Center
  • Butte Montana 59701 United States
  • Benefis Healthcare- Sletten Cancer Institute
  • Great Falls Montana 59405 United States
  • Great Falls Clinic
  • Great Falls Montana 59405 United States
  • Saint Peter's Community Hospital
  • Helena Montana 59601 United States
  • Kalispell Regional Medical Center
  • Kalispell Montana 59901 United States
  • Saint Patrick Hospital - Community Hospital
  • Missoula Montana 59802 United States
  • Community Medical Hospital
  • Missoula Montana 59804 United States
  • CHI Health Saint Francis
  • Grand Island Nebraska 68803 United States
  • CHI Health Good Samaritan
  • Kearney Nebraska 68847 United States
  • Saint Elizabeth Regional Medical Center
  • Lincoln Nebraska 68510 United States
  • Nebraska Methodist Hospital
  • Omaha Nebraska 68114 United States
  • Alegent Health Immanuel Medical Center
  • Omaha Nebraska 68122 United States
  • Alegent Health Bergan Mercy Medical Center
  • Omaha Nebraska 68124 United States
  • Alegent Health Lakeside Hospital
  • Omaha Nebraska 68130 United States
  • Creighton University Medical Center
  • Omaha Nebraska 68131 United States
  • Midlands Community Hospital
  • Papillion Nebraska 68046 United States
  • Carson Tahoe Regional Medical Center
  • Carson City Nevada 89703 United States
  • Cancer and Blood Specialists-Henderson
  • Henderson Nevada 89052 United States
  • Comprehensive Cancer Centers of Nevada - Henderson
  • Henderson Nevada 89052 United States
  • Comprehensive Cancer Centers of Nevada-Horizon Ridge
  • Henderson Nevada 89052 United States
  • Las Vegas Cancer Center-Henderson
  • Henderson Nevada 89052 United States
  • OptumCare Cancer Care at Seven Hills
  • Henderson Nevada 89052 United States
  • 21st Century Oncology-Henderson
  • Henderson Nevada 89074 United States
  • Comprehensive Cancer Centers of Nevada-Southeast Henderson
  • Henderson Nevada 89074 United States
  • Las Vegas Urology - Pebble
  • Henderson Nevada 89074 United States
  • Las Vegas Urology - Pecos
  • Las Vegas Nevada 89074 United States
  • Desert West Surgery
  • Las Vegas Nevada 89102 United States
  • University Medical Center of Southern Nevada
  • Las Vegas Nevada 89102 United States
  • Hope Cancer Care of Nevada
  • Las Vegas Nevada 89103 United States
  • Cancer and Blood Specialists-Shadow
  • Las Vegas Nevada 89106 United States
  • OptumCare Cancer Care at Oakey
  • Las Vegas Nevada 89106 United States
  • Radiation Oncology Centers of Nevada Central
  • Las Vegas Nevada 89106 United States
  • 21st Century Oncology
  • Las Vegas Nevada 89109 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  • Las Vegas Nevada 89109 United States
  • Sunrise Hospital and Medical Center
  • Las Vegas Nevada 89109 United States
  • HealthCare Partners Medical Group Oncology/Hematology-San Martin
  • Las Vegas Nevada 89113 United States
  • Radiation Oncology Centers of Nevada Southeast
  • Las Vegas Nevada 89119 United States
  • 21st Century Oncology-Vegas Tenaya
  • Las Vegas Nevada 89128 United States
  • Ann M Wierman MD LTD
  • Las Vegas Nevada 89128 United States
  • Cancer and Blood Specialists-Tenaya
  • Las Vegas Nevada 89128 United States
  • Comprehensive Cancer Centers of Nevada - Northwest
  • Las Vegas Nevada 89128 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  • Las Vegas Nevada 89128 United States
  • Las Vegas Urology - Cathedral Rock
  • Las Vegas Nevada 89128 United States
  • Las Vegas Urology - Smoke Ranch
  • Las Vegas Nevada 89128 United States
  • OptumCare Cancer Care at MountainView
  • Las Vegas Nevada 89128 United States
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  • Las Vegas Nevada 89135 United States
  • Comprehensive Cancer Centers of Nevada - Town Center
  • Las Vegas Nevada 89144 United States
  • Comprehensive Cancer Centers of Nevada-Summerlin
  • Las Vegas Nevada 89144 United States
  • Summerlin Hospital Medical Center
  • Las Vegas Nevada 89144 United States
  • Las Vegas Cancer Center-Medical Center
  • Las Vegas Nevada 89148-2405 United States
  • 21st Century Oncology-Fort Apache
  • Las Vegas Nevada 89148 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89148 United States
  • OptumCare Cancer Care at Fort Apache
  • Las Vegas Nevada 89148 United States
  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  • Las Vegas Nevada 89149 United States
  • Comprehensive Cancer Centers of Nevada - Central Valley
  • Las Vegas Nevada 89169 United States
  • University Cancer Center
  • Las Vegas Nevada 89169 United States
  • Hope Cancer Care of Nevada-Pahrump
  • Pahrump Nevada 89048 United States
  • Renown Regional Medical Center
  • Reno Nevada 89502 United States
  • Saint Mary's Regional Medical Center
  • Reno Nevada 89503 United States
  • Radiation Oncology Associates
  • Reno Nevada 89509 United States
  • New Hampshire Oncology Hematology PA-Concord
  • Concord New Hampshire 03301 United States
  • New Hampshire Oncology Hematology PA-Hooksett
  • Hooksett New Hampshire 03106 United States
  • Hematology Oncology Associates of Central New York-Auburn
  • Auburn New York 13021 United States
  • Mary Imogene Bassett Hospital
  • Cooperstown New York 13326 United States
  • Hematology Oncology Associates of Central New York-East Syracuse
  • East Syracuse New York 13057 United States
  • Hematology Oncology Associates of Central New York-Onondaga Hill
  • Syracuse New York 13215 United States
  • Duke University Medical Center
  • Durham North Carolina 27710 United States
  • Margaret R Pardee Memorial Hospital
  • Hendersonville North Carolina 28791 United States
  • Sanford Bismarck Medical Center
  • Bismarck North Dakota 58501 United States
  • Essentia Health Cancer Center-South University Clinic
  • Fargo North Dakota 58103 United States
  • Sanford South University Medical Center
  • Fargo North Dakota 58103 United States
  • Southpointe-Sanford Medical Center Fargo
  • Fargo North Dakota 58103 United States
  • Sanford Medical Center Fargo
  • Fargo North Dakota 58104 United States
  • Sanford Broadway Medical Center
  • Fargo North Dakota 58122 United States
  • Sanford Roger Maris Cancer Center
  • Fargo North Dakota 58122 United States
  • Essentia Health - Jamestown Clinic
  • Jamestown North Dakota 58401 United States
  • Strecker Cancer Center-Belpre
  • Belpre Ohio 45714 United States
  • Adena Regional Medical Center
  • Chillicothe Ohio 45601 United States
  • Good Samaritan Hospital - Cincinnati
  • Cincinnati Ohio 45220 United States
  • Bethesda North Hospital
  • Cincinnati Ohio 45242 United States
  • TriHealth Cancer Institute-Westside
  • Cincinnati Ohio 45247 United States
  • TriHealth Cancer Institute-Anderson
  • Cincinnati Ohio 45255 United States
  • Mount Carmel East Hospital
  • Columbus Ohio 43213 United States
  • Columbus Oncology and Hematology Associates Inc
  • Columbus Ohio 43214 United States
  • Riverside Methodist Hospital
  • Columbus Ohio 43214 United States
  • Grant Medical Center
  • Columbus Ohio 43215 United States
  • The Mark H Zangmeister Center
  • Columbus Ohio 43219 United States
  • Mount Carmel Health Center West
  • Columbus Ohio 43222 United States
  • Doctors Hospital
  • Columbus Ohio 43228 United States
  • Delaware Health Center-Grady Cancer Center
  • Delaware Ohio 43015 United States
  • Grady Memorial Hospital
  • Delaware Ohio 43015 United States
  • Dublin Methodist Hospital
  • Dublin Ohio 43016 United States
  • Central Ohio Breast and Endocrine Surgery
  • Gahanna Ohio 43230 United States
  • Fairfield Medical Center
  • Lancaster Ohio 43130 United States
  • OhioHealth Mansfield Hospital
  • Mansfield Ohio 44903 United States
  • Marietta Memorial Hospital
  • Marietta Ohio 45750 United States
  • OhioHealth Marion General Hospital
  • Marion Ohio 43302 United States
  • Knox Community Hospital
  • Mount Vernon Ohio 43050 United States
  • Licking Memorial Hospital
  • Newark Ohio 43055 United States
  • Newark Radiation Oncology
  • Newark Ohio 43055 United States
  • Mercy Health Perrysburg Cancer Center
  • Perrysburg Ohio 43551 United States
  • Southern Ohio Medical Center
  • Portsmouth Ohio 45662 United States
  • Mercy Saint Anne Hospital
  • Toledo Ohio 43623 United States
  • Toledo Clinic Cancer Centers-Toledo
  • Toledo Ohio 43623 United States
  • Saint Ann's Hospital
  • Westerville Ohio 43081 United States
  • Genesis Healthcare System Cancer Care Center
  • Zanesville Ohio 43701 United States
  • Cancer Centers of Southwest Oklahoma Research
  • Lawton Oklahoma 73505 United States
  • University of Oklahoma Health Sciences Center
  • Oklahoma City Oklahoma 73104 United States
  • Mercy Hospital Oklahoma City
  • Oklahoma City Oklahoma 73120 United States
  • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • Tulsa Oklahoma 74146 United States
  • Saint Alphonsus Medical Center-Baker City
  • Baker City Oregon 97814 United States
  • Saint Charles Health System
  • Bend Oregon 97701 United States
  • Clackamas Radiation Oncology Center
  • Clackamas Oregon 97015 United States
  • Providence Oncology and Hematology Care Southeast
  • Clackamas Oregon 97015 United States
  • Bay Area Hospital
  • Coos Bay Oregon 97420 United States
  • Providence Newberg Medical Center
  • Newberg Oregon 97132 United States
  • Saint Alphonsus Medical Center-Ontario
  • Ontario Oregon 97914 United States
  • Providence Portland Medical Center
  • Portland Oregon 97213 United States
  • Providence Saint Vincent Medical Center
  • Portland Oregon 97225 United States
  • Oregon Health and Science University
  • Portland Oregon 97239 United States
  • Saint Charles Health System-Redmond
  • Redmond Oregon 97756 United States
  • Guthrie Medical Group PC-Robert Packer Hospital
  • Sayre Pennsylvania 18840 United States
  • Greenville Health System Cancer Institute-Easley
  • Easley South Carolina 29640 United States
  • Saint Francis Hospital
  • Greenville South Carolina 29601 United States
  • Greenville Health System Cancer Institute-Butternut
  • Greenville South Carolina 29605 United States
  • Greenville Health System Cancer Institute-Faris
  • Greenville South Carolina 29605 United States
  • Greenville Memorial Hospital
  • Greenville South Carolina 29605 United States
  • Saint Francis Cancer Center
  • Greenville South Carolina 29607 United States
  • Greenville Health System Cancer Institute-Eastside
  • Greenville South Carolina 29615 United States
  • Greenville Health System Cancer Institute-Greer
  • Greer South Carolina 29650 United States
  • Greenville Health System Cancer Institute-Seneca
  • Seneca South Carolina 29672 United States
  • Greenville Health System Cancer Institute-Spartanburg
  • Spartanburg South Carolina 29307 United States
  • Sanford Cancer Center Oncology Clinic
  • Sioux Falls South Dakota 57104 United States
  • Sanford USD Medical Center - Sioux Falls
  • Sioux Falls South Dakota 57117-5134 United States
  • Wellmont Bristol Regional Medical Center
  • Bristol Tennessee 37620 United States
  • Regional Cancer Center at Indian Path Community Hospital
  • Kingsport Tennessee 37660 United States
  • Wellmont Holston Valley Hospital and Medical Center
  • Kingsport Tennessee 37660 United States
  • Saint Joseph Regional Cancer Center
  • Bryan Texas 77802 United States
  • Wellmont Medical Associates-Bristol
  • Bristol Virginia 24201 United States
  • Bon Secours Memorial Regional Medical Center
  • Mechanicsville Virginia 23116 United States
  • Bon Secours Saint Francis Medical Center
  • Midlothian Virginia 23114 United States
  • Bon Secours DePaul Medical Center
  • Norfolk Virginia 23505 United States
  • Southwest VA Regional Cancer Center
  • Norton Virginia 24273 United States
  • Bon Secours Maryview Medical Center
  • Portsmouth Virginia 23707 United States
  • Bon Secours Saint Mary's Hospital
  • Richmond Virginia 23226 United States
  • Bon Secours Health Center at Harbour View
  • Suffolk Virginia 23435 United States
  • Providence Regional Cancer System-Aberdeen
  • Aberdeen Washington 98520 United States
  • PeaceHealth Saint Joseph Medical Center
  • Bellingham Washington 98225 United States
  • Harrison HealthPartners Hematology and Oncology-Bremerton
  • Bremerton Washington 98310 United States
  • Harrison Medical Center
  • Bremerton Washington 98310 United States
  • Highline Medical Center-Main Campus
  • Burien Washington 98166 United States
  • Providence Regional Cancer System-Centralia
  • Centralia Washington 98531 United States
  • Swedish Cancer Institute-Edmonds
  • Edmonds Washington 98026 United States
  • Saint Elizabeth Hospital
  • Enumclaw Washington 98022 United States
  • Providence Regional Cancer Partnership
  • Everett Washington 98201 United States
  • Saint Francis Hospital
  • Federal Way Washington 98003 United States
  • Swedish Cancer Institute-Issaquah
  • Issaquah Washington 98029 United States
  • Kadlec Clinic Hematology and Oncology
  • Kennewick Washington 99336 United States
  • Providence Regional Cancer System-Lacey
  • Lacey Washington 98503 United States
  • Saint Clare Hospital
  • Lakewood Washington 98499 United States
  • PeaceHealth Saint John Medical Center
  • Longview Washington 98632 United States
  • Harrison HealthPartners Hematology and Oncology-Poulsbo
  • Poulsbo Washington 98370 United States
  • Pacific Gynecology Specialists
  • Seattle Washington 98104 United States
  • Swedish Medical Center-Ballard Campus
  • Seattle Washington 98107 United States
  • Swedish Medical Center-First Hill
  • Seattle Washington 98122-4307 United States
  • Swedish Medical Center-Cherry Hill
  • Seattle Washington 98122-5711 United States
  • PeaceHealth United General Medical Center
  • Sedro-Woolley Washington 98284 United States
  • Providence Regional Cancer System-Shelton
  • Shelton Washington 98584 United States
  • Franciscan Research Center-Northwest Medical Plaza
  • Tacoma Washington 98405 United States
  • PeaceHealth Southwest Medical Center
  • Vancouver Washington 98664 United States
  • Providence Saint Mary Regional Cancer Center
  • Walla Walla Washington 99362 United States
  • Providence Regional Cancer System-Yelm
  • Yelm Washington 98597 United States
  • Duluth Clinic Ashland
  • Ashland Wisconsin 54806 United States
  • Northwest Wisconsin Cancer Center
  • Ashland Wisconsin 54806 United States
  • Saint Vincent Hospital Cancer Center Green Bay
  • Green Bay Wisconsin 54301 United States
  • Saint Vincent Hospital Cancer Center at Saint Mary's
  • Green Bay Wisconsin 54303 United States
  • Holy Family Memorial Hospital
  • Manitowoc Wisconsin 54221 United States
  • Saint Vincent Hospital Cancer Center at Marinette
  • Marinette Wisconsin 54143 United States
  • Cancer Center of Western Wisconsin
  • New Richmond Wisconsin 54017 United States
  • Saint Vincent Hospital Cancer Center at Oconto Falls
  • Oconto Falls Wisconsin 54154 United States
  • HSHS Saint Nicholas Hospital
  • Sheboygan Wisconsin 53081 United States
  • Saint Vincent Hospital Cancer Center at Sturgeon Bay
  • Sturgeon Bay Wisconsin 54235-1495 United States
  • Cheyenne Regional Medical Center-West
  • Cheyenne Wyoming 82001 United States
  • Billings Clinic-Cody
  • Cody Wyoming 82414 United States
  • Welch Cancer Center
  • Sheridan Wyoming 82801 United States

View trial on ClinicalTrials.gov


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