Kidney/Renal Cancer

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Phase II Study of Olaparib in Metastatic Renal Cell Carcinoma Patients Harboring a BAP-1 or Other DNA Repair Gene Mutations (ORCHID)


Condition: Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer, Renal Carcinoma, Kidney Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03786796

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 120 Years
  • Gender: All

Inclusion Criteria:

  • Willing and able to provide written informed consent. Provision of informed consent is required prior to any study procedures.
  • Patients aged 18 years of age or older.
  • Histological proof of renal cell carcinoma (both clear cell and non-clear cell allowed).
  • Metastatic (AJCC Stage IV) renal cell carcinoma.
  • Somatic or germline mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L as documented by a clinical CLIA-grade, tissue, saliva or blood-based genetic test.
  • At least one prior treatment with an anti-angiogenic agent or immune checkpoint inhibitor.
  • Any number of prior systemic therapies is allowed (cytokine, anti-angiogenic, mTOR, immune checkpoint blockage or clinical trial).
  • Must have measurable disease as defined by RECIST 1.1 criteria.
  • Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional ULN unless liver metastases are present in which case they must be ≤ 5 x ULN. Note: Patients with elevations in bilirubin, AST, or ALT should be thoroughly evaluated for the etiology of this abnormality prior to entry and patients with evidence of viral infection should be excluded.
  • Patients must have a creatinine clearance ≥ 40 mL/min calculated by Cockroft-Gault formula or 24 hour urine test.
  • ECOG PS ≤ 1.
  • Participants must have a life expectancy ≥ 16 weeks.
  • Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as:
  • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments.
  • Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50 years old.
  • Radiation-induced oophorectomy with last menses > 1 year ago.
  • Chemotherapy-induced menopause with > 1 year interval since last menses.
  • Surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.

Exclusion Criteria:

  • Other malignancy unless curatively treated with no evidence of disease for ≥ 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma. Patients with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy > 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease.
  • Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
  • Breast feeding women.
  • Use of any prohibited concomitant medications within the prior 2 weeks.
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • Participation in another clinical study with an investigational product during the last 2 weeks.
  • Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
  • Any previous treatment with PARP inhibitor, including olaparib.
  • Resting ECG with QTc > 500 ms and/or indication of uncontrolled cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, electrolyte disturbances, etc.), or patients with congenital and/or family history of long QT syndrome.
  • Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. During the study, if co-administration of a strong or moderate inhibitor is required because there is no suitable alternative medication, exception to this criterion may be allowed with a suitable dose reduction of olaparib.
  • Concomitant use of known strong CYP3A inducers (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital or enzalutamide and 3 weeks for other agents.
  • Persistent toxicities (> Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
  • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
  • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
  • Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
  • Unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • Known hypersensitivity to olaparib or any of the excipients of the product.
  • Known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
  • No packed red blood cells and/or platelet transfusions within the last 28 days prior to study entry.

View trial on ClinicalTrials.gov


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Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)


Condition: Renal Cell Carcinoma, Urothelial Carcinoma

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT03374267

Sponsor: iOMEDICO AG

Phase:

Eligibility:

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

Inclusion Criteria:

  • Female and male patients with aRCC or aUBC (locally advanced, inoperable or metastatic)
  • Patients at start of their first-line systemic treatment for aRCC or aUBC
  • Written informed consent
  • Patients participating in the PRO module: signing of in-formed consent form and completion of baseline questionnaire before start of initial systemic treatment
  • Patients not participating in the PRO module: within twelve weeks after start of systemic first-line for aRCC or aUBC
  • Age ≥ 18 years

Exclusion Criteria:

  • Patients with prior systemic therapy for aRCC or aUBC
  • No systemic treatment for aRCC or aUBC

View trial on ClinicalTrials.gov


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Phase I/II Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03172754

Sponsor: Fox Chase Cancer Center

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced RCC with predominantly clear cell subtype.
  • Archival tumor biospecimen (when available) must be procured for correlative evaluation. If tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study.
  • Formalin fixed, paraffin embedded [FFPE] tissue block(s) or at least 12 unbaked, unstained slides are required. Tissue samples taken from a metastatic lesion prior to the start of screening are acceptable.
  • At least one measurable lesion as defined by RECIST version 1.1.
  • Age > 18 years.
  • ECOG performance status 0 or 1
  • Adequate bone marrow, kidney, and liver function as defined by: WBC ≥ 2000/μL. Neutrophils ≥ 1500/μL. Platelets ≥ 100 x103/μL. Hemoglobin > 9.0 g/dL. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula): Female CrCl = (140
  • age in years) x (weight in kg x 0.85)/(72 x serum creatinine in mg/dL). Male CrCl = (140
  • age in years) x (weight in kg x 1.00)/(72 x serum creatinine in mg/dL). AST/ALT ≤ 3 x ULN. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).
  • No evidence of pre-existing uncontrolled hypertension as documented by 2 baseline blood pressure (BP) readings taken at least 1 hour apart. The baseline systolic BP readings must be ≤ 150 mm Hg, and the baseline diastolic BP readings must be ≤ 90 mm Hg
  • Patients enrolled to the prior treatment arm of the expansion cohort must have been exposed to a TKI for metastatic disease OR treated with the combination of ipilimumab and nivolumab in the 1st line setting for metastatic disease. Exposure to TKI as part of (neo)adjuvant treatment that completed within 1 year of study qualifies as prior exposure as well. Prior high dose interleukin-2 is allowed and patients who received this as their only prior line of treatment for metastatic disease may be included in the treatment naïve group.

Exclusion Criteria:

  • Prior therapy with axitinib
  • Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to the expansion cohort, treatment naïve arm. If prior (neo)adjuvant treatment given as part of a clinical trial, this would be allowed as long as last dose was > 1 year prior to start of treatment
  • Patients enrolled to the prior treatment arm of the dose escalation cohort must not have received anti-cancer therapy less than 14 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
  • Patients are excluded if they have active, symptomatic brain metastases or leptomeningeal metastases. Subjects with known brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for four weeks (after treatment is complete and within 28 days prior to study drug administration.
  • Second malignancy requiring active systemic treatment
  • Diagnosis of immunodeficiency
  • Active, known or suspected autoimmune disease. Subjects are permitted to enroll 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
  • Patients have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Major surgery <4 weeks or radiation therapy <2 weeks of study entry. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
  • Gastrointestinal abnormalities including: Inability to take oral medication; Requirement for intravenous alimentation; Prior surgical procedures affecting absorption including total gastric resection; Treatment for active peptic ulcer disease in the past 6 months; Active gastrointestinal bleeding as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; Malabsorption syndromes.
  • Evidence of inadequate wound healing.
  • Active bleeding disorder or other history of significant bleeding episodes within 30 days before study entry.
  • Known prior or suspected hypersensitivity to study drugs or any component in their formulations.
  • Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice. The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.
  • Current use or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort.
  • As there is potential for hepatic toxicity with nivolumab, drugs with a predisposition to hepatotoxicity should be used with caution in patients treated with nivolumab-containing regimen.
  • Known hepatitis B virus (HBV) or hepatitis C virus (HBV) infection.
  • Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • History of any of the following cardiovascular conditions within 12 months of screening: Myocardial infarction, Unstable angina pectoris, Cardiac angioplasty or stenting, Coronary/peripheral artery bypass graft, Class III or IV congestive heart failure per New York Heart Association, Cerebrovascular accident or transient ischemic attack
  • History of deep vein thrombosis or pulmonary embolism within 6 months of screening. Patients who are currently taking anticoagulation therapy for a prior history (> 6 months from screening) of thrombosis may still be eligible.
  • Pregnant or breast feeding.

View trial on ClinicalTrials.gov


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Genetic Evaluation of Renal Cell Carcinoma; Predicting Biomarkers for Renal Cell Carcinoma


Condition: Kidney Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03414827

Sponsor: Zealand University Hospital

Phase:

Eligibility:

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

Inclusion Criteria:

  • Patients who have been diagnosed with kidney cancer.

Exclusion Criteria:

  • Patients without signs of malignancy at final histology report.
  • Incapacitated patients.

View trial on ClinicalTrials.gov


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CABRAMET: A Phase 2 Study of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases


Condition: Metastatic Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03967522

Sponsor: Centre Leon Berard

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • I1. Age ≥ 18 years. I2. Histologically proven metastatic Renal Cell Carcinoma. I3. Brain metastases not requiring corticosteroids at dose > 40 mg/day. I4.At least 1 locally untreated brain lesion ≥8mm in longest diameter or >5mm if > 1 lesion. I5.Not previously treated by cabozantinib. I6.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1. I7.Life expectancy ≥ 3 months I8.Adequate organ function as defined by the following criteria:
  • Total serum bilirubin ≤ 2 x ULN (Gilbert's disease exempted)
  • Serum transaminases and alkaline phosphatases ≤ 2.5 x ULN, or in case of liver or bone metastasis ≤ 5.0 x ULN
  • Serum creatinine ≤ 2 x ULN OR creatinine clearance ≥ 50 ml/min
  • Absolute neutrophil count (ANC) ≥ 1 500/mm3
  • Platelets ≥ 100 000/mm3 (100 G/l)
  • Hemoglobin ≥ 9.0 g/dl. I9. Covered by a medical/health insurance. I10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. I11. Signed and dated IRB/ICE approved informed consent form. I12. Accepting to use effective contraception (barrier contraceptives) during study treatment and within at least 4 months after final dose of study therapy. Oral contraceptives are not acceptable.

Exclusion Criteria:

  1. E
  2. Any local previous treatment of current brain metastases. E
  3. Any anti-coagulation therapy (except preventive treatment at low dose). E
  4. Contra-indication of Magnetic Resonance Imaging (MRI) (i.e. : pace-maker). E
  5. Uncontrolled seizures. E
  6. Any symptoms of intracranial hypertension. E
  7. Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, ischemic or hemorrhagic stroke including transient ischemic attack. E
  8. Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical treatment. E
  9. Ongoing cardiac dysrhythmia of grade ≥ 2, atrial fibrillation of any grade, QTc interval > 0.
  10. E
  11. Pregnant or breast feeding woman (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential). E
  12. Any acute or chronic medical or psychiatric condition or laboratory abnormality that would make the patient unsuited to study participation. E
  13. Any second malignancy within the last 3 years with the exception of basal cell carcinoma, in situ cervical cancer and pT1/a bladder cancer with no evidence of recurrent disease for 12 months. E
  14. Patients receiving strong inhibitor or inducer of CYP3A4 especially some anti-epileptic drugs. E
  15. Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements. E
  16. Participation to another clinical trial that might interfere with the evaluation of the main criterion. E
  17. Known hypersensitivity to the active substance or to any of the excipients of cabozantinib. E
  18. Patient requiring tutorship or curatorship.

View trial on ClinicalTrials.gov


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Monitoring of Treatment Related Toxicities From Oral Targeted Agents and Immunotherapy Among Patients With Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study


Condition: Advanced Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03229083

Sponsor: University of Rochester

Eligibility:

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

Inclusion Criteria:

  • Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
  • Greater than 18 years of age
  • A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
  • Able to provide written informed consent
  • Proficient in the English language and self-reports as literate
  • Must have an active email address or access to a smart device on which text messages can be received

Exclusion Criteria:

  • Women cannot be breast-feeding
  • Does not have regular access to the internet
  • Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
  • Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change

View trial on ClinicalTrials.gov


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An Exploratory Study of 89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04006522

Sponsor: James Brugarolas

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patients with suspected renal cell carcinoma with planned surgery or patients with metastatic RCC and a tissue diagnosis. (In standard clinical practice, biopsy is not routinely performed in patients who will be having surgery).
  • Ability to understand and the willingness to sign a written informed consent.
  • Patient must be able to lie still for a 30 to 60 minute PET/CT scan.
  • One of the following: 1. Patients with locally advanced RCC planned for surgery determined to be a high risk of recurrence, defined by presence of at least clinical T2 or TxN1, OR patients with metastatic RCC for whom treatment with cytoreductive nephrectomy and/or metastasectomy is planned by the treating physician. 2. Patients with metastatic RCC for whom immuno-oncology (IO) therapy is planned.
  • Women of child-bearing potential must agree to undergo and have documented a negative pregnancy test on the day of 89Zr-DFO-Atezolizumab administration. A 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:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to atezolizumab or any other chimeric or humanized antibodies.
  • Uncontrolled severe and irreversible intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  • Significant autoimmune disease requiring treatment with either prednisone (or steroid equivalent) at a dose > 10 mg/day or other immunosuppressive agents. (Replacement steroid therapy is acceptable).
  • Any patient for whom ICI therapy would be contraindicated for other reasons. Patients with adverse reactions to ICI therapy may undergo second 89Zr-DFO-Atezolizumab injection and PET/CT at the discretion of the treating physician considering that the dose of antibody represents 1% of a single therapeutic dose and therefore unlikely to cause adverse events.
  • Subjects unable to provide informed consent.
  • Subjects who are claustrophobic or have other contraindications to PET/CT.
  • Subjects must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed. (>200 kg or 440 lbs).

View trial on ClinicalTrials.gov


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A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients With Localized Clear Cell Renal Cell Carcinoma (SPARC-1 Trial)


Condition: Carcinoma, Renal Cell

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04028245

Sponsor: Columbia University

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: All

Inclusion Criteria:

  • Radiographically consistent with or histologically confirmed clear cell RCC or predominantly clear cell RCC
  • Localized non-metastatic RCC T1b-T4NanyM0 or TanyN1M0)
  • Schedule to undergo either partial or radical nephrectomy as part of the treatment plan
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Age ≥ 18 years old at time of consent
  • HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes as defined by the following
  • Cluster of differentiation 4 (CD4+) T cell counts ≥ 350 cells/microliter OR undetectable HIV viral load
  • no history of AIDS-defining opportunistic infection in the last year
  • Normal organ and marrow function as defined below:
  • White blood cell count (WBC) > 3.0 K/mm3
  • Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
  • Platelets ≥ 100 K/mm3
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Serum total bilirubin: ≤ 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN
  • Serum creatinine ≤ 1.5 x ULN or serum creatinine > 1.5
  • 3 x ULN if calculated
  • creatinine clearance (CrCl) is ≥ 30 mL/min
  • For patients with known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • For patients with a history of hepatitis C virus (HCV) infection, the infection must be treated and cured
  • Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
  • Willingness to use barrier contraception from the time of first dose of canakinumab and spartalizumab until 120 days after surgical intervention

Exclusion Criteria:

  • Presence of distant metastases
  • Presence of active, known or suspected autoimmune disease.
  • No patients with documented, active infections, treated or untreated, may be included in this study
  • Use of any live vaccines against infectious disease within 4 weeks of initiation ot study treatment.
  • Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways
  • Prior treatment for RCC including surgery, radiation, thermoablation, or systemic therapy
  • Surgery within 28 days of starting study treatment
  • Prior treatment with any antibody or drug targeting T cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
  • Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed
  • Allogenic bone marrow or solid organ transplant
  • History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
  • History or current interstitial lung disease or non-infectious pneumonitis requiring the use of home oxygen
  • History of severe hypersensitivity reaction to other monoclonal antibodies
  • Current signs or symptoms of severe progressive or uncontrolled, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or cardiac disease other than directly related to RCC
  • Positive tests for hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
  • History of known or suspected autoimmune disease with the following exceptions:
  • Vitiligo
  • Resolved childhood atopic dermatitis
  • Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).
  • Patients with Grave's disease or Hashimoto's thyroiditis that are now euthyroid clinically and by laboratory testing.
  • History of malignancy within the last 2 years, with the exception of non-melanoma skin cancers and superficial bladder cancer
  • Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate

View trial on ClinicalTrials.gov


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A Prospective Study of Clinical Factors Affecting Disease Progression and Treatment Results of Patients With Tumors of the Prostate, Bladder and Kidney.


Condition: Kidney Cancer, Prostate Cancer, Bladder Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02186925

Sponsor: Meir Medical Center

Phase:

Eligibility:

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

Inclusion Criteria:

  • All patients with prostate, bladder or kidney cancer that are being treated at the Meir Medical Center and are over 18 years of age.

Exclusion Criteria:

  • Patients under the age of 18

View trial on ClinicalTrials.gov


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A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy


Condition: Renal Cell Carcinoma, Metastatic, Renal Cell Cancer, Recurrent

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03013946

Sponsor: AIO-Studien-gGmbH

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  2. Age ≥ 18 years at time of study entry
  3. Advanced or metastatic renal cell carcinoma, not amendable to surgery with curative intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment with sunitinib
  4. Intended first-line treatment with sunitinib
  5. Documented progressive disease within 6 months prior to study inclusion
  6. Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as well as non-measurable disease are eligible.
  7. Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects.
  8. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
  9. Subject is willing to receive additional concomitant coaching and able to comply with the QoL/PRO (patient-reported outcome) assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up.

Exclusion Criteria:

  1. Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative radiotherapy)
  2. Previous malignancy (other than mRCC) which either progresses or requires active treatment. Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor [Ta, Tis and T1].
  3. CNS metastases, unless local therapy has been completed for at least 3 month and patient does not require the use of steroids.
  4. Chronic liver disease with Child-Pugh B or C score
  5. Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year)
  6. Any condition that, in the opinion of the investigator, would interfere with evaluation of the concomitant coaching or QoL assessments or interpretation of patient safety or study results
  7. Participation in another clinical study with an investigational product during the last 30 days before inclusion
  8. Any previous treatment with a tyrosine kinase inhibitor for metastatic disease. Adjuvant or neoadjuvant therapy for localized disease is permitted, provided that relapse occurred at least 6 months after last exposure
  9. Previous enrollment or randomization in the present study (does not include screening failure).
  10. Involvement in the planning and/or conduct of the study (applies to both Pfizer staff and/or staff of sponsor and study site)
  11. Patient who might be affiliated or otherwise dependent on the sponsor, site or the investigator
  12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
  13. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

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Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors


Condition: Renal Tumor, Wilms Tumor

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03810651

Sponsor: Children's Hospital of Philadelphia

Phase: Early Phase 1

Eligibility:

  • Age: minimum 0 Years maximum 30 Years
  • Gender: All

Inclusion Criteria:

  • Less than 30 years of age
  • Diagnosis a. Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care including 1. Any patient with favorable histology (FH), stage III disease 2. Any patient with focal or diffuse anaplasia 3. Any patient with CCSK
  • The patient is a candidate for external beam radiotherapy based on standard of care for treatment of Wilms tumor or CCSK

Exclusion Criteria:

  • Prior radiotherapy to the region of the study cancer
  • Chemotherapy administered for diagnosis of Wilms tumor or CCSK
  • Pregnant or breastfeeding

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Evaluation of a Promising New Combination of Protein Kinase Inhibitors on Organotypic Cultures of Human Renal Tumors


Condition: Kidney Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03571438

Sponsor: University Hospital, Grenoble

Eligibility:

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

Inclusion Criteria:

  • major patient treated at the University Hospital of Grenoble for a renal tumor with suspected or confirmed malignancy.This includes non-metastatic patients undergoing renal lumpectomy, partial nephrectomy or total nephrectomy, as well as metastatic or locally advanced cancer patients undergoing cytoreductive surgery who are eligible for medical treatment at the same time

Exclusion Criteria:

  • Contaminated patients with HIV and /or HBV (hepatitis B virus) and / or HCV (hepatitis C virus) positive serology.
  • Absence or withdrawal of the informed consent of the patient.
  • Tumors smaller than 2 cm on preoperative imaging

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Neoadjuvant AXITINIB and AVELUMAB for Patients With Localized Clear-cell RCC and a Moderate to High Risk


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03341845

Sponsor: The Netherlands Cancer Institute

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Signed and written informed consent
  • Male or female patients age ≥ 18 years
  • Histologically confirmed diagnosis of non-metastatic clear-cell renal cell carcinoma of intermediate to high risk with completely resectable primary tumours.
  • World Health Organization performance status of 0-1.
  • Adequate coagulation function as defined in protocol
  • Adequate hematological function as defined in protocol
  • Adequate hepatic function as defined in protocol
  • Adequate renal function as defined in protocol
  • Negative serum pregnancy test at screening for women of childbearing potential.
  • Highly effective contraception for both male and female subjects if the risk of conception exists.

Exclusion Criteria:

  • Renal tumors of low risk or M1
  • Non-clear cell histology at biopsy
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
  • Corrected QT interval (QTc) > 480 msecs
  • History of any of the cardiovascular conditions defined in the protocol within the past 6 months
  • Poorly controlled hypertension
  • History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
  • Evidence of active bleeding or bleeding diathesis.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
  • Unable or unwilling to discontinue use of prohibited medications to be listed in protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
  • Treatment with any of the following anti-cancer therapies: chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of axitinib or avelumab
  • Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
  • Prior organ transplantation, including allogeneic stem cell transplantation
  • Significant acute or chronic infections as defined in protocol
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Known severe hypersensitivity reactions to monoclonal antibodies
  • Pregnancy or lactation
  • Known alcohol or drug abuse

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A Pilot Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Renal Cell Carcinoma


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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02542202

Sponsor: University of Chicago

Eligibility:

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

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed metastatic or recurrent RCC (any histologic subtype)
  • Patients must have between 1 to 5 new or recurrent lesions suspicious for metastatic RCC on diagnostic imaging
  • Each extracranial lesion must be =< 6 cm and amenable to SBRT or surgical excision
  • Patients must have 3 or fewer brain metastases, of size =< 4 cm
  • Brain metastases must be treated prior to enrollment in the study; the modality of treatment of brain metastases can include surgical resection, whole brain radiotherapy, stereotactic radiosurgery, or any combination of the above
  • Patients who have an intact unresected primary tumor should be considered for radical nephrectomy and primary resection prior to enrollment in the study; if the patient is not eligible for surgical resection, the primary tumor must be amenable to SBRT or request for applications (RFA); generally, this will be defined as a primary tumor < 10 cm in size or a primary lesion which can be treated to a dose of >= 8 Gy x 5 without excessive perceived risk of toxicity
  • Patients must have had at least a computed tomography (CT) of the chest, abdomen, and pelvis within 4 weeks of registration in the trial; CT or magnetic resonance imaging (MRI) of the brain is only required in the presence of neurologic symptoms
  • Patients must have had no radiotherapy, immunotherapy, chemotherapy or therapy with targeted agents within the last 1 month
  • Patients may not have had prior bevacizumab, based on case reports of tracheoesophageal fistula in patients treated with bevacizumab and radiotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status =<2
  • Age 18 years or older
  • Life expectancy of >= 3 months
  • Patients must have normal organ and marrow function within 30 days of registration, as defined below:
  • Absolute neutrophil count >= 500/mcL
  • Hemoglobin >= 8.0 g/dL
  • Platelets >= 50,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional upper limit of normal if liver metastases are present
  • Women of childbearing potential must have a negative pregnancy test within 14 days of registration
  • Patients must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy within 1 month of enrollment
  • Patients who have had any prior bevacizumab, due to case reports suggesting a possible risk of severe toxicity in combination with radiotherapy
  • Patients with radiographic or clinical findings of spinal cord compression or cauda equina syndrome with neurologic deficit thought to be due to malignancy
  • Patients may not be receiving any systemic anti-cancer agents or other investigational agents during radiation therapy
  • Patients may not have received prior radiation therapy to a site of recurrence which would require overlap of appreciable radiation dose
  • Known active invasive malignancy except for renal cell carcinoma and/or non-melanoma skin cancer
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration;
  • Transmural myocardial infarction within the last 6 months prior to registration;
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration;
  • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease if the liver is involved with metastatic disease;
  • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
  • Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment

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Renal Tumors Classification, Biology, and Banking Study


Condition: Adult Cystic Nephroma, Anaplastic Kidney Wilms Tumor, Angiolipoma, Cellular Congenital Mesoblastic Nephroma, Classic Congenital Mesoblastic Nephroma, Clear Cell Sarcoma of the Kidney, Congenital Mesoblastic Nephroma, Cystic Partially Differentiated Kidney Nephroblastoma, Diffuse Hyperplastic Perilobar Nephroblastomatosis, Extrarenal Rhabdoid Tumor, Kidney Medullary Carcinoma, Kidney Neoplasm, Kidney Oncocytoma, Kidney Wilms Tumor, Metanephric Adenofibroma, Metanephric Adenoma, Metanephric Stromal Tumor, Metanephric Tumor, Mixed Congenital Mesoblastic Nephroma, Ossifying Renal Tumor of Infancy, Papillary Renal Cell Carcinoma, Renal Cell Carcinoma, Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions, Rhabdoid Tumor of the Kidney, Wilms Tumor

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00898365

Sponsor: Children's Oncology Group

Phase:

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, forms, and copies of imaging studies must be available or will become available for submission and the institution must intend on submitting them as described in the protocol procedures
  • For ALL patients, (with exception of bilateral, bilaterally predisposed, multicentric, 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 (including from sampled lymph nodes, if patient had upfront nephrectomy)
  • * Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed favorable histology Wilms tumor [FHWT] patients discovered to have diffuse anaplastic Wilms tumor [DAWT] at delayed nephrectomy and plan to enroll at delayed nephrectomy)
  • Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor, if available.
  • Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed FHWT patients discovered to have DAWT at delayed nephrectomy and plan to enroll at delayed nephrectomy)
  • Institutional pathology report, Specimen Transmittal Form, and Pre-Treatment Pathology Checklist
  • Copies of images and institutional reports of CT and/or MRI abdomen and pelvis, and Pre Treatment Imaging Checklist
  • Copies of images and institutional report of chest CT for all malignant tumors
  • Institutional surgical report(s) and Pre-Treatment Surgical Checklist
  • CRFs: Staging Checklist and Metastatic Disease Form (if metastatic disease is noted on imaging)
  • Patients with bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy via imaging only
  • these patients will not have central review or have a risk assignment issued, but may contribute to specimen banking for future research. 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. The Specimen Transmittal Form and Pre Treatment Pathology Checklist are also needed.
  • Please note: if the above required items are not received within 120 days of study enrollment, the patient will be considered off study
  • 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

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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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03685448

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

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 Creatinine clearance (CrCl) ≥ 30mL/min (use Cockcroft-Gault Formula, refer to Appendix 2) 2. Urinalysis (dipstick) negative for protein, or for those with positive protein detected on urinalysis (≥2+), urine protein-to-creatinine ratio (UPCR) ≤ 1mg/mg (≤ 113.2mg/mmol)
  • 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, must agree to use a condom during intercourse and must agree to refrain from sperm donation 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). Note: If FFPE tumour tissue block is not obtainable, then unstained slides are also acceptable. If archival tissue is not available, patient must be willing to provide a fresh tumour biopsy.
  • 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.
  • 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.
  • Concurrent treatment with strong CYP3A4 inducers or inhibitors (such as ketoconazole and rifampicin), P-glycoprotein substrates (such as fexofenadine, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol and tolvaptan), MRP2 inhibitors (such as cyclosporine, efavirenz and emtricitabine), or direct oral anticoagulants such as thrombin inhibitors or factor Xa inhibitors. Use of low molecular weight heparin (LMWH) is permitted.
  • 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.
  • Other significant active infection, including hepatitis B, hepatitis C and HIV. Hepatitis and HIV testing is not mandatory unless clinically indicated.
  • Participants should be excluded if they have a history of allergy to study drug components or problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption
  • Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
  • Patient is pregnant or breastfeeding.

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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 the Bone, Metastatic Malignant Neoplasm in the Lymph Nodes, Metastatic Malignant Neoplasm in the Soft Tissues, Metastatic Malignant Neoplasm in the Viscera, Sarcomatoid Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03793166

Sponsor: National Cancer Institute (NCI)

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 or rhabdoid features
  • Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1.
  • Measurable disease as defined in the protocol.
  • Must be intermediate or poor risk patient per International Metastatic Renal Cell Carcinoma Database (IMDC) criteria (1 or more of the following): Karnofsky performance status [KPS] < 80, < 1 year from diagnosis [including initial nephrectomy] to systemic treatment for metastatic disease, 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. The only exception is for prior treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or post-operative trials, as long as > 1 year since completion of systemic therapy.
  • No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 [> 28 days] and prior adjuvant sunitinib > 180 days since completion and prior immunotherapy as above are allowed).
  • No systemic cancer therapy less than 28 days prior to registration; no radiation therapy 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.
  • Age >= 18 years
  • Absolute neutrophil count (ANC) >= 1,500/mm^3.
  • Platelet count >= 100,000/mm^3.
  • Hemoglobin >= 8 g/dL.
  • 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) (except for patients with known or likely Gilbert's syndrome, for whom total bilirubin up to 3 mg/dL is allowed with direct bilirubin =< 20% total bilirubin)
  • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 2.5 x upper limit of normal (ULN) or < 5 x ULN if hepatic metastases present.
  • 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 (this criteria does not include any adverse events [AEs] not attributable to treatment which are present due to disease), with prednisone-equivalent dosing at 10 mg daily or less. Exceptions for this criteria include patients receiving replacement hormone treatments (such as levothyroxine for treatment-related hypothyroidism or glucocorticoid replacement for adrenal insufficiency). Please contact study chair if further discussion is needed.
  • No more than 80 days from last dose of ipilimumab/nivolumab.

Exclusion Criteria:

  • 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.
  • Active hepatitis B/C, or active tuberculosis (PPD response without active TB is allowed)
  • Human immunodeficiency virus (HIV) -infected patients with detectable viral load within 6 months prior to registration. Patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible.
  • 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 (this does not include tumor thrombus extending into/through renal vein/inferior vena cava [IVC]). Patients with tumor thrombus extending into/through renal vein are considered eligible.
  • 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 (treated hypothyroidism on thyroid replacement therapy is allowed. Abnormal thyroid-stimulating hormone (TSH) is acceptable with normal T3/free T4 if treated on thyroid replacement therapy)
  • Evidence of pancreatitis, history of organ transplant, or history of congenital QT syndrome.
  • Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Allowed also in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
  • Significant cardiac ischemia events (ST elevation myocardial infarction [STEMI] or non-ST elevation myocardial infarction [NSTEMI]) within 6 months or active NY Heart Association class 3-4 heart failure symptoms

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Prospective Non-interventional Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment


Condition: Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03647878

Sponsor: Ipsen

Phase:

Eligibility:

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

Inclusion Criteria:

  • Males or females aged 18 years and older with capacity to consent.
  • Subjects receiving cabozantinib as monotherapy or in combination with nivolumab as a first line treatment for advanced or metastatic renal cell carcinoma
  • Subjects with the intention to be treated with cabozantinib tablets as monotherapy or in combination with nivolumab according to the current local Summary of Product Characteristics (SmPC); decision has to be taken before entry in the study.
  • Signed written informed consent

Exclusion Criteria:

  • Participation in an interventional study at the same time and/or within 3 months before baseline.
  • Previous participation in this study

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Preventive Effects of Low-dose Aspirin as Adjuvant Therapy After Radical Nephrectomy on Disease Recurrence/Metastasis and Survival in Patients With Locally Advanced Renal Cell Carcinoma: an Observational Prospective Cohort Study


Condition: Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03734614

Sponsor: RenJi Hospital

Phase:

Eligibility:

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

Inclusion Criteria:

  • Patients must complete radical surgery more than 4 weeks and less than 12 weeks prior to study entry
  • Patients must have histologically or cytologically confirmed renal cell carcinoma. Using 2017 (American Joint Committee on Cancer [AJCC] 8th edition) TNM Staging, patients must be one of the following:
  • pT2aG3 or G4N0M0
  • pT2bG(any)N0M0
  • pT3G(any)N0M0
  • pT4G(any)N0M0
  • pT(any)G(any)N1M0
  • Patients must have no clinical or imaging evidence of visible residual lesions or distant metastases (M0) after nephrectomy
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Patients must be able to swallow pills

Exclusion Criteria:

  • Patients with haemorrhagic diathesis (i.e. haemophilia).
  • Patients with prior malignant tumors except for kidney cancers in the past 5 years.
  • Patients with documented or suspected metastases.
  • Patients with serious, nonhealing wound, ulcer, or bone fracture.
  • Patients with a history of stroke, coronary arterial disease, angina, or vascular disease.
  • Patients who are pregnant, lactating, or not using adequate contraception.
  • Patients who have known allergy to NSAID or Aspirin.
  • Patients receiving other antiplatelet agents (i.e. clopidogrel, ticlopidine) or anticoagulants (i.e. warfarin, low molecular weight heparins).
  • Patients receiving current long term treatment (≥1 month) with Aspirin or other NSAIDs.
  • Subject unwilling or unable to comply with study requirements.

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Famitinib Malate Plus Anti-PD1 Therapy (SHR-1210) in Advanced Renal Cell Carcinoma, Urothelial Carcinoma, Advanced Cervical Cancer, Relapse Ovarian Cancer, Endometrial Cancer: Multi-institutional, Open-label, Phase 2 Trial


Condition: Renal Cell Carcinoma, Urothelial Carcinoma, Cervical Cancer, Ovarian Cancer Recurrent, Endometrial Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03827837

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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 at least 18 years of age on day of signing informed consent, male or female. 3. Patients with one of the following tumors:
  • Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma (defined as more than 50% clear cell component) after failure of IL-2 and/or anti-VEGF TKI treatment. If patients didn't want to use anti-VEGF TKI medicine or couldn't stand anti-VEGF TKI medicine costs, they will also be considered.
  • Histologically or cytologically confirmed diagnosis of unresectable urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra (defined as more than 50% transitional cell component) after failure of no more than two prior platinum-based chemotherapeutic regimen.
  • Histologically or cytologically confirmed diagnosis of advanced squamous cell carcinoma of the cervix after failure of first-line system treatment.
  • Histologically confirmed diagnosis of recurrent or refractory epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer that are relapsed and resistant (recurred less than 6 months after chemotherapy) or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen.
  • Histologically confirmed diagnosis of recurrent or refractory endometrial cancer that are relapsed and resistant or refractory (progressed on chemotherapy) to prior platinum-based standard care systemic regimen. 4. At least one measurable lesion according to RECIST 1.1. 5. The patients can swallow pills. 6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. 7. Life expectancy of at least 12 weeks. 8. The results of patients' blood tests are as follows:-Neutrophils≥1.5E+9/L; - Plt≥90E+9/L; -Hb≥90g/L; -ALB≥30g/L ;-TSH≤1×ULN;-TBIL ≤ 1 ×ULN;-ALT and AST ≤ 3 ×ULN; AKP≤ 2.5×ULN; -Creatinine ≤ 1.5×ULN. 9. Male or Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.

Exclusion Criteria:

  1. Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
  2. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
  3. Known history of hypersensitivity to other antibody formulation.
  4. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 2 weeks prior to trial treatment.
  5. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥ 90 mmHg.
  6. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to(1)Congestive heart failure (New York heart association (NYHA) class > 2);(2)unstable or severe angina; (3)myocardial infarction within 12 months before enrollment;(4) ventricular arrhythmia which need medical intervention.(5)QTc>450ms(male)/QTc>470ms (female);
  7. Coagulation abnormalities (INR>2.0、PT>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
  8. Bleeding history, having bleeding event(≥3 Grade according CTCAE 4.0 )within 4 weeks before screening.
  9. Tumor invasion around major vessels shown by imaging, high risk of major vascular invasion leading to massive hemorrhage judged by investigators.
  10. Previous Arterial/venous thrombosis events within 6 months.
  11. Known hereditary or acquired bleeding and thrombosis tendency.
  12. Proteinuria ≥ (++) and 24 hours total urine protein > 1.0 g.
  13. Prior chemotherapy, radiotherapy, surgery therapy within 4 weeks or palliative radiotherapy within 2 weeks or target therapy within 5 half-life of the drug before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade
  14. Active infection or an unexplained fever > 38.5°C within 7 days before the study drug administration, or baseline WBC>15×E+9/L .
  15. Has known history of Interstitial lung disease, or using steroids evidence of active, non-infectious pneumonitis, or would interfere with the detection and handling of suspicious drug-related pulmonary toxicity.
  16. History of immunodeficiency or human immunodeficiency virus (HIV) infection.
  17. HBV DNA>500 IU/ml,HCV RNA>1000copies/ml,HBsAg+ and anti-HCV+;
  18. Has a known additional malignancy within the last 5 years, or that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or patients with recurrent ovarian cancer has a known additional breast cancer that has been radical mastectomy and doesn't relapse within 3 years.
  19. Patients with treatment history of SHR-1210 or any other PD-L1 or PD-1 antagonists or famitinib.
  20. Patients who may receive live vaccine during the study, or previous had vaccination within 4 weeks.
  21. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's safety and participate in the study or would interfere with the interpretation of the results or lead to the trial being terminated early.

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