Kidney/Renal Cancer

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A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma


Condition: Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma

Intervention:

  • Biological: NKTR-214
  • Drug: Sunitinib
  • Biological: Nivolumab
  • Drug: Cabozantinib

Purpose: The main purpose of this study is to compare the overall response rate (ORR) and overall survival (OS) of NKTR-214 combined with nivolumab to that of a tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in intermediate and poor-risk participants with previously untreated advanced renal cell carcinoma (RCC).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03729245

Sponsor: Nektar Therapeutics

Primary Outcome Measures:

  • Measure: Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)
  • Time Frame: Approximately 2 years
  • Safety Issue:
  • Measure: Overall survival (OS)
  • Time Frame: 27-48 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression-free survival (PFS) by BICR
  • Time Frame: 27-48 months
  • Safety Issue:
  • Measure: Incidence of treatment-related Adverse Events (AEs)
  • Time Frame: Up to 5 years
  • Safety Issue:
  • Measure: ORR using RECIST 1.1 by investigator and in biomarker population
  • Time Frame: 27-48 months
  • Safety Issue:
  • Measure: PFS by investigator and in biomarker population
  • Time Frame: 27-48 months
  • Safety Issue:
  • Measure: OS in biomarker population
  • Time Frame: 27-48 months
  • Safety Issue:
  • Measure: Changes in cancer-related symptoms and quality-of-life in patients using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (NCCN/FACT) Symptom Index for Kidney Cancer (FKSI-19)
  • Time Frame: 27-48 months
  • Safety Issue:

Estimated Enrollment: 600

Study Start Date: December 28, 2018

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Provide written, informed consent to participate in the study and follow the study procedures
  • Karnofsky Performance Status (KPS) of at least 70
  • Measurable disease per RECIST 1.1 criteria
  • Histological confirmation of advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with clear cell component including patients who may have sarcomatoid features
  • At least one International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic factors must be present to qualify as either intermediate or poor risk renal cell carcinoma
  • No prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for RCC
  • Patients with stable brain metastases may be enrolled if certain criteria are met
  • Archival tumor tissue available Exclusion Criteria:
  • Patients who have an active, known or suspected autoimmune disease
  • Patients who have a known additional malignancy that is progressing or requires active treatment
  • Any tumor invading the superior vena cava (SVC) or other major blood vessels
  • Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 30 days prior to randomization Other protocol defined inclusion/

Exclusion Criteria:

  • Patients who have an active, known or suspected autoimmune disease
  • Patients who have a known additional malignancy that is progressing or requires active treatment
  • Any tumor invading the superior vena cava (SVC) or other major blood vessels
  • Any tumor invading the gastrointestinal (GI) tract or any evidence of endotracheal or endobronchial tumor within 30 days prior to randomization Other protocol defined inclusion/exclusion criteria could apply

Contact:

  • Nektar Recruitment
  • 855-482-8676

Locations:

  • Investigator Site - Goodyear
  • Goodyear Arizona 85338 United States
  • Investigator Site - Whittier
  • Whittier California 90603 United States
  • Investigator Site - Kettering
  • Kettering Ohio 45429 United States
  • Investigator Site - Portland
  • Portland Oregon 97213 United States
  • Investigator Site - Houston
  • Houston Texas 77030 United States
  • Investigator Site - Fairfax
  • Fairfax Virginia 22031 United States
  • Investigator Site - Leesburg
  • Leesburg Virginia 20176 United States
  • Investigator Site - Rosario
  • Rosario Santa Fe S2000DSV Argentina
  • Investigator Site - Kurralta Park
  • Kurralta Park South Australia 5037 Australia
  • Investigator Site - Porto Alegre
  • Porto Alegre Rio Grande Do Sul 90610-000 Brazil
  • Investigator Site - Santiago
  • Santiago 7500921 Chile
  • Investigator Site - Beijing
  • Beijing 100142 China
  • Investigator Site - Bogotá
  • Bogotá 111321 Colombia
  • Investigator Site - Hong Kong
  • Hong Kong Hong Kong
  • Investigator Site - Monterrey
  • Monterrey 64000 Mexico
  • Investigator Site - Christchurch
  • Christchurch 8011 New Zealand
  • Investigator Site - Lima
  • Lima Lima 13 Peru
  • Investigator Site - Saint Petersburg
  • Saint Petersburg 199178 Russian Federation
  • Investigator Site - Singapore
  • Singapore 258499 Singapore

View trial on ClinicalTrials.gov


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Phase II Study of Optimized Management of NIVOlumab Based on REsponse in Patients With Advanced Renal Cell Carcinoma (OMNIVORE Study)


Condition: Renal Cancer

Intervention:

  • Drug: Ipilimumab
  • Drug: Nivolumab

Purpose: This research study is studying two drugs at different time points as a possible treatment for advanced renal cell cancer The drugs involved in this study are: Nivolumab Ipilimumab

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03203473

Sponsor: Dana-Farber Cancer Institute

Primary Outcome Measures:

  • Measure: Number of subjects with persistent Partial Response (PR) or Complete Response (CR) at 1 year since nivolumab discontinuation (Arm A)
  • Time Frame: 1 year after discontinuation with nivolumab
  • Safety Issue:
  • Measure: Number of subjects with Progressive Disease (PD) or Stable Disease (SD) that convert to PR or CR at 1 year upon the addition of ipilimumab to nivolumab (Arm B)
  • Time Frame: 1 year after addition of ipilimumab to nivolumab
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression Free Survival
  • Time Frame: Disease will be evaluated every 8 or 12 weeks (depending on treatment) from study entry until disease progression, up to 24 months.
  • Safety Issue:
  • Measure: Overall Survival
  • Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months.
  • Safety Issue:
  • Measure: Salvage therapy-free interval
  • Time Frame: On Arm A, the time from nivolumab discontinuation to the receipt of re-starting nivolumab, on average about 12 months.
  • Safety Issue:
  • Measure: Immune related objective response rate (irORR)
  • Time Frame: Disease will be evaluated every 8 or 12 weeks (depending on treatment) from study entry until disease progression per irORR criteria, up to 24 months.
  • Safety Issue:
  • Measure: Safety and tolerability according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.
  • Time Frame: Throughout the course of the study, approximately 24 months after study entry
  • Safety Issue:

Estimated Enrollment: 58

Study Start Date: September 26, 2017

Phase: Phase 2

Eligibility:

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

Exclusion Criteria:

  • Subjects meeting any of the criteria below may not participate in the study:
  • Prior use of systemic checkpoint inhibitors for the management of metastatic RCC is excluded. Prior IFN-α or IL-2 is allowed.
  • Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitors) within 2 weeks of enrollment or receipt of any anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy) within 4 weeks of enrollment.
  • Treatment with systemic immunosuppressive medications including but not limited to:
  • prednisone, dexamethasone, cyclosporin, azathioprine, methotrexate, thalidomide, anti- tumor necrosis factor (TNF) agents within 2 weeks of first study dose.
  • Subjects who have received acute, low-dose systemic immunosuppressant medications may be enrolled (such as steroids for acute nausea or cancer-related pain ≤ 10 mg prednisone) may be enrolled sooner than 2 weeks of first study dose.
  • Subjects with adrenal insufficiency on physiologic replacement doses of steroids may be enrolled (≤ 10 mg prednisone).
  • The use of inhaled, topical, ocular or intra-articular corticosteroids and mineralocorticoids are allowed.
  • Treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g. denosumab) within 2 weeks of first study dose.
  • Radiotherapy for RCC within 14 days of first study treatment with the exception of a single fraction of radiation administered for palliation of symptoms.
  • Known active metastases to the brain, spinal cord or leptomeninges unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks of first study treatment as documented by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging and having no ongoing requirement for steroids.
  • Malignancies other than RCC within 5 years of first study treatment with the exception of those with negligible risk of metastases or death and/or treated with expected curative outcome (carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, non-muscle invasive urothelial carcinoma).
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein.
  • Known hypersensitivity to any component of the nivolumab or ipilimumab product.
  • Any active or recent history (within 6 months of first study dose) of autoimmune disease or syndrome that requires systemic corticosteroids (>10 mg daily prednisone equivalent) or immunosuppressive medications including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegner's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Subjects with vitiligo, controlled type I diabetes mellitus, hypo- or hyperthyroid disease, or surgical adrenal insufficiency requiring hormone replacement therapy are permitted to enroll.
  • Any condition requiring treatment with corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of the first dose of study drug. Inhaled, topical, ocular or intra-articular steroids and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Uncontrolled adrenal insufficiency.
  • History of idiopathic pulmonary fibrosis, organized pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening imaging CT of the chest. History of radiation pneumonitis in the radiation field is permitted.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
  • Known active or chronic hepatitis B infection (defined as having a positive hepatitis B surface antigen (HBsAg) test at screening). Subject with past or resolved hepatitis B infection (defined as having a negative HBsAg test and positive antibody to hepatitis B core antigen test) are eligible. Hepatitis B viral DNA must be obtained in subjects with positive hepatitis B core antibody prior to first treatment start.
  • Active hepatitis C infection. Subjects positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA.
  • Severe infections within 4 weeks of first study treatment including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Receipt of therapeutic oral or IV antibiotics within 2 weeks of first study treatment. Subjects receiving routine antibiotic prophylaxis (for dental extractions/procedures) are eligible.
  • Significant cardiovascular disease such as New York Heart Association (NYHA) class III or greater, myocardial infarction within the previous 3 months, unstable arrhythmias, unstable angina. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 45% must be on a stable regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist when appropriate.
  • Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening EKG > 500 msec.
  • History of abdominal or tracheoesophageal fistula or GI perforation within 6 months of first study treatment.
  • Clinical signs or symptoms of GI obstruction or requirement of routine parenteral nutrition.
  • Evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
  • Serious, non-healing or dehiscing wound or active ulcer
  • Major surgical procedure within 4 weeks of first study treatment.
  • Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0) or baseline before administration of study drug.
  • Prior allogenic stem cell or solid organ transplant.
  • Administration of a live, attenuated vaccine within 4 weeks for first study treatment.

Contact:

  • Lauren C Harshman, MD
  • 617-632-4524

Locations:

  • University of California, San Diego Moores Cancer Center
  • La Jolla California 92093 United States
  • University of Chicago Medical Center
  • Chicago Illinois 60637 United States
  • Beth Israel Deaconess Medical Center
  • Boston Massachusetts 02115 United States
  • Dana Farber Cancer Institute
  • Boston Massachusetts 02115 United States
  • University of North Carolina at Chapel Hill
  • Chapel Hill North Carolina 27599 United States
  • Lifespan Comprehensve Cancer Center
  • Providence Rhode Island 02903 United States
  • University of Utah, Huntsman Cancer Center
  • Salt Lake City Utah 84112 United States
  • Unviersity of Wisconsin Carbone Cancer Center
  • Madison Wisconsin 53792 United States

View trial on ClinicalTrials.gov


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A Phase 2 Open-Label Study of Nivolumab Combined With Cabozantinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (CA209-9KU)


Condition: Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma

Intervention:

  • Drug: cabozantinib
  • Drug: nivolumab

Purpose: The purpose of this study is to compare any good and bad effects of using a combination of nivolumab (Opdivo®) and cabozantinib (Cabometyx®) in people with metastatic kidney cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03635892

Sponsor: Memorial Sloan Kettering Cancer Center

Primary Outcome Measures:

  • Measure: objective response rate
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 37

Study Start Date: August 13, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Signed and dated IRB-approved Informed Consent Form
  • Pathologic or histologically confirmed unresectable advanced or metastatic nccRCC
  • 0 or 1 prior systemic therapies, including treatment in the adjuvant setting
  • Availability of a representative formalin fixed, paraffin embedded tumor specimen or fresh frozen tissue specimen that enables the definitive diagnosis of RCC, accompanied by an associated pathology report. Specimens can be collected by surgical resection or biopsy of the primary tumor or biopsy or resection of a metastatic lesion.
  • Measurable disease, as defined by RECIST 1.1
  • Age ≥18 years
  • KPS ≥ 70
  • Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless adverse events (AE(s)) are clinically nonsignificant and/or stable on supportive therapy.
  • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
  • ANC ≥ 1500 cells/μL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
  • WBC counts ≥ 2500/μL and ≤ 15,000/μL without G-CSF
  • Lymphocyte count ≥ 500/μL
  • Platelet count ≥100,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
  • Hemoglobin ≥9.0 g/dL
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN). ALP ≤ 5 x ULN with documented bone metastases.
  • Serum bilirubin ≤ 1.5 x ULN
  • Serum albumin ≥ 2.8 g/dl
  • Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled.
  • INR and aPTT ≤ 1.5 x ULN • This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
  • Creatinine ≤ 2.0 x ULN or Calculated Creatinine clearance ≥ 30mL/min
  • For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception, including at least one method with a failure rate of ≥ 1% per year
  • Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol)
  • Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of study treatment for females and 7 months for males.
  • 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.
  • Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.

Exclusion Criteria:

  • Prior treatment with an immunotherapy agent including high dose IL-2, anti-CTLA-4, anti-PD1, and anti-PD-L1 agents
  • Prior treatment with cabozantinib for non-clear cell RCC
  • Receipt of any type of small molecule kinase inhibitor within 2 weeks of treatment.
  • Receipt of any type of anti-cancer antibody, cytotoxic anticancer therapy, or any other investigational agents within 4 weeks of treatment start
  • Known malignancies of the brain or spinal cord or leptomeningeal disease
  • Patients requiring pain medication must be on a stable regimen at study entry
  • Any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroids > 10 mg daily prednisone equivalents are allowed in the absence of autoimmune disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled hypercalcemia (≥ 1.5 mmol/L ionized calcium or Ca ≥ 12 mg/dL or corrected serum calcium ≥ ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy
  • Pregnant and lactating women History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • History of HIV infection
  • Patients with active or chronic hepatitis B or hepatitis C infection
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 6 months, unstable arrhythmias, unstable angina, or EF < 50%
  • Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment
  • Patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
  • Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (eg, simple excision, biopsy, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
  • History of stroke or transient ischemic attack within 6 months prior to Cycle 1, Day 1
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
  • Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
  • Patients with a history of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment
  • Other clinically significant disorders that would preclude safe study participation
  • Serious non-healing wound/ulcer/bone fracture
  • Uncompensated/symptomatic hypothyroidism
  • Moderate to severe hepatic impairment (Child-Pugh B or C)
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment Note: If a single ECG shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility
  • Inability to swallow tablets or capsules
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
  • The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 14 days of first dose of study treatment
  • Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following:
  • Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted
  • Low-dose low molecular weight heparins (LMWH) are permitted
  • Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
  • Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose
  • Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation
  • The subject has tumor invading or encasing any major blood vessels
  • The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
  • Uncontrolled hypertension (>150 mmHg systolic or > 100 mmHg diastolic despite optimal antihypertensive treatment)
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. Radiation for palliation is allowable on study.

Contact:

  • Chung-Han Lee, MD, PhD
  • 646-888-5418

Locations:

  • Memoral Sloan Kettering Basking Ridge
  • Basking Ridge New Jersey 07920 United States
  • Memoral Sloan Kettering Monmouth
  • Middletown New Jersey 07748 United States
  • Memorial Sloan Kettering Bergen
  • Montvale New Jersey 07645 United States
  • Memorial Sloan Kettering Commack
  • Commack New York 11725 United States
  • Memoral Sloan Kettering Westchester
  • Harrison New York 10604 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Memorial Sloan Kettering Rockville Centre
  • Rockville Centre New York 11570 United States
  • Memorial Sloan Kettering Nassau
  • Uniondale New York 11553 United States

View trial on ClinicalTrials.gov


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


Condition: Advanced or Metastatic Renal Cell Carcinoma

Purpose: The purpose of the protocol, is to describe the use of CabometyxTM (cabozantinib) tablets including the number of dose reductions, dose interruptions and terminations due to (serious) adverse events in subjects with advanced or metastatic renal cell carcinoma (mRCC) treated in real-life clinical setting in 1st line treatment.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03647878

Sponsor: Ipsen

Primary Outcome Measures:

  • Measure: The proportion of subjects with dose reduction due to Serious Adverse Events/Adverse Events (SAEs/AEs)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: The proportion of subjects with dose interruption due to SAEs/AEs
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: The proportion of subjects with termination of Cabozantinib due to SAEs/AEs
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression free survival (PFS)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Best overall response - Overall Response Rate (ORR)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Best overall response - Disease Control Rate (DCR)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Impact of the activity level at baseline on the occurrence of adverse events (AEs)
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: The proportion of subjects with termination due to SAEs/AEs in sub-group
  • Time Frame: 2 year
  • Safety Issue:
  • Measure: The proportion of subjects with dose interruption due to SAEs/AEs in sub-group
  • Time Frame: 2 year
  • Safety Issue:
  • Measure: The proportion of subjects with dose reduction due to SAEs/AEs in sub-group
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 105

Study Start Date: September 24, 2018

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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 a first line treatment for advanced or metastatic renal cell carcinoma
  • Subjects with the intention to be treated with cabozantinib tablets according to the current local Summary of Product Characteristics (SmPC) (Germany, Austria); 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

Contact:

  • Ipsen Recruitment Enquiries

Locations:

  • Landeskrankenhaus Hochsteiermark
  • Leoben Austria
  • St. Georg Klinikum
  • Eisenach Germany

View trial on ClinicalTrials.gov


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A Phase 2 Trial of PT2977 in Combination With Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma


Condition: RCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer, Renal Cancer, Renal Cell Carcinoma, Renal Cell Cancer Metastatic, Renal Cell Carcinoma Recurrent, Renal Cell Cancer, Recurrent, Kidney

Intervention:

  • Drug: PT2977 in combination with cabozantinib tablets

Purpose: An open-label Phase 2 study of PT2977 in combination with cabozantinib in patients with advanced ccRCC.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03634540

Sponsor: Peloton Therapeutics, Inc.

Primary Outcome Measures:

  • Measure: Overall Response Rate (ORR)
  • Time Frame: Approximately 2 Years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression Free Survival (PFS)
  • Time Frame: Approximately 2 Years
  • Safety Issue:
  • Measure: Duration of Response (DOR)
  • Time Frame: Approximately 2 Years
  • Safety Issue:
  • Measure: Time to Response (TTR)
  • Time Frame: Approximately 2 Years
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: Approximately 2 Years
  • Safety Issue:

Estimated Enrollment: 118

Study Start Date: September 21, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Has the ability to understand and willingness to sign a written informed consent form before the performance of any study-specific procedures
  • 18 years of age or older
  • Has locally advanced or metastatic RCC with predominantly clear cell subtype
  • Has at least one measurable lesion as defined by RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Has adequate organ function defined as follows:
  • Absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL and platelet count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening;
  • Serum creatinine level ≤ 2.0 × upper limit of normal (ULN)
  • Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease
  • Cohort 1: Patients must not have received prior systemic therapy for advanced or metastatic ccRCC
  • Cohort 2: Patients must have received prior immunotherapy and no more than two prior treatments for advanced or metastatic ccRCC

Exclusion Criteria:

  • Has received prior treatment with PT2977 or other HIF2α inhibitors
  • Has received prior treatment with cabozantinib
  • Has had radiation therapy for bone metastases within two weeks of starting study drug
  • Has a history of untreated brain metastases or history of leptomeningeal disease or spinal cord compression
  • Has failed to recover from the reversible effects of prior anticancer therapy
  • Has uncontrolled or poorly controlled hypertension
  • Is receiving anticoagulant therapy
  • Has had any major cardiovascular event within 6 months prior to study drug administration
  • Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
  • Has had major surgery within 3 months before first study drug administration
  • Has an active infection requiring systemic treatment
  • Is participating in another therapeutic clinical trial

Contact:

  • Richard Kelley
  • 972-629-4088

Locations:

  • Cedars-Sinai Medical Center
  • Los Angeles California 90048 United States
  • University of Miami - Sylvester Comprehensive Cancer Center
  • Miami Florida 33136 United States
  • Dana-Farber Cancer Institute
  • Boston Massachusetts 02215 United States
  • Barbara Ann Karmanos Cancer Institute
  • Detroit Michigan 48201 United States
  • Tennessee Oncology - Chattanooga
  • Chattanooga Tennessee 37404 United States
  • Tennessee Oncology
  • Nashville Tennessee 37203 United States
  • Swedish Cancer Institute
  • Seattle Washington 98104 United States
  • University of Washington
  • Seattle Washington 98109 United States

View trial on ClinicalTrials.gov


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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

Intervention:

  • Drug: Low dose of aspirin

Purpose: The study evaluates the protective effect of low-dose aspirin use as adjuvant therapy on locally advanced renal cell carcinoma in users and non-users of aspirin in Renji Hospital, Shanghai, China.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03734614

Sponsor: RenJi Hospital

Primary Outcome Measures:

  • Measure: Disease-free Survival
  • Time Frame: 36 mouths
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival
  • Time Frame: 36 months
  • Safety Issue:
  • Measure: Cancer specific survival
  • Time Frame: 36 months
  • Safety Issue:
  • Measure: adverse event rate
  • Time Frame: 12 months
  • Safety Issue:

Estimated Enrollment: 260

Study Start Date: October 8, 2018

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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.

Contact:

  • jiwei huang, M.D.
  • 8613651682825

Location:

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
  • Shanghai Shanghai 200123 China

View trial on ClinicalTrials.gov


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A Study of Anti-PD-1( Pembrolizumab) Combinations of D-CIK (Cytokine-induced Killer Cells Are Stimulated Using Mature Dendritic Cells) Immunotherapy and Axitinib in Advanced Ranal Carcinoma


Condition: Renal Cancer Metastatic

Intervention:

  • Biological: Combinations treatment

Purpose: Phase II clinical trial to investigate the safety, clinical activity and toxicity of combinations of D-CIK and low dose anti-PD-1 antibody in patients with metastatic renal cell carcinoma treated with axitinib.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03736330

Sponsor: Sun Yat-sen University

Primary Outcome Measures:

  • Measure: Objective Response Rate(ORR)by irRC and RECIST 1.1
  • Time Frame: 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression-free Survival(PFS)by irRC and RECIST 1.1
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Overall Survival (OS) by irRC and RECIST 1.1
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Duration of Response (DOR) by irRC and RECIST 1.1
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: The quality of life by EQ-5D-5L and NCCN-FACT FKSI-19 v2.0.
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Severity of adverse events as assessed by CTCAE v4.0
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 24

Study Start Date: September 8, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • advanced renal clear cell carcinoma confirmed by pathology: high-volume disease without systemic treatment(including primary lesion unable to surgery, multiple lymph node metastases or distant metastases), or achieved disease progression after treatment by the anti-angiogenesis therapy (TKI or mTOR inhibitors) or by cytokines or combination therapy
  • Predicted survival >=3 months
  • At least 1 measurable lesion High-volume disease(meet one of the following criteria):1. More than 3 sites of lesions with or without primary lesions, and at least 1 lesion routine CT or spiral CT scan >=3cm; 2. Unresected primary lesions (> 10cm), accompanied by 2 metastatic lesions; 3. After nephrectomy, single metastasis, at least 3 metastases, and at least one lesion > 2cm; 4. After nephrectomy, multiple metastatic(>3 organs) and at least one lesion > 2cm.

Exclusion Criteria:

  • Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody and Axitinib
  • Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components
  • Severe cardiovascular and cerebrovascular diseases, uncontrollable severe hypertension and diabetes, severe renal insufficiency or uremia
  • Long-term use of immunosuppressive agents after organ transplantation
  • Immunosuppressive drugs are currently in use
  • People with a clear and serious infection
  • Predicted survival<3 months
  • Patients with T cell lymphoma, myeloma
  • Patients with autoimmune diseases
  • HIV positive, or other immunodeficiency diseases
  • Pregnant or nursing

Contact:

  • Fangjian Zhou, MD.PhD
  • 86-20-87343312

Location:

  • Cancer Center, Sun Yat-sen University
  • Guangzhou Guangdong 510060 China

View trial on ClinicalTrials.gov


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Ipilimumab & Nivolumab Combination Therapy: A Study of a Supervised or Semi-Supervised Exercise InterveNtion or Usual Care With Functional Capacity and Quality of Life Evaluations in Subjects With Advanced or MEtastatic Renal Cell Carcinoma


Condition: Metastatic Renal Cell Carcinoma

Intervention:

  • Behavioral: Exercise

Purpose: This study aims to report the effects of immediate or delayed exercise training on patients with advanced or metastatic renal cell carcinoma who are receiving nivolumab and ipilimumab.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03692338

Sponsor: Duke University

Primary Outcome Measures:

  • Measure: Change in Cardiopulmonary function,
  • Time Frame: Baseline, 13 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Patient-reported fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale
  • Time Frame: 13 weeks
  • Safety Issue:
  • Measure: Patient-reported activity as measured by the Godin Leisure Time Exercise Questionnaire
  • Time Frame: 13 weeks
  • Safety Issue:
  • Measure: Patient-reported symptoms as measured by the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19)
  • Time Frame: 13 weeks
  • Safety Issue:
  • Measure: Patient health outcome as measured by the EQ-5D health questionnaire
  • Time Frame: 13 weeks
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: November 19, 2018

Eligibility:

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

Inclusion Criteria:

  • Age ≥18 years.
  • Histologically confirmed renal cell carcinoma (RCC).
  • Locally advanced, unresectable or metastatic disease, in the opinion of the investigator.
  • Scheduled to receive ipilimumab and nivolumab per standard of care.
  • No prior checkpoint inhibitor therapy for RCC.
  • Subjects with brain metastases are allowed if they are asymptomatic, without edema, and not on systemic corticosteroids or receiving radiation therapy for at least 14 days prior to beginning protocol therapy.
  • Karnofsky Performance Status (KPS) of at least 70%
  • Able to walk on a treadmill, in the opinion of the treating physician.
  • Must be able to complete an acceptable cardiopulmonary exercise test (CPET) at baseline (see Section 5.5) defined as at least one of the following:
  • Achieving a plateau in oxygen consumption concurrent with an increase in power output, or
  • A respiratory exchange ratio ≥ 1.1 (RER), or
  • Volitional exhaustion with a rating of perceived exertion ≥17 (RPE).
  • To participate in the optional fitness tracker cohort, the patient must either have a Bluetooth-enabled smart phone that is compatible with the wireless fitness tracker or be willing and able to upload data weekly via an internet-connected computer.
  • Ability to understand English and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Major surgery (e.g. nephrectomy) less than 28 days prior to the first dose of study drug.
  • Palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
  • History of cerebrovascular accident including transient ischemic attack (TIA) within the past 6 months.
  • Osseous metastatic disease with unacceptable risk of impending fracture due to study assessments, in the opinion of the investigator. Note: This criterion must be met prior to CPET.
  • Absolute contraindications to cardiopulmonary exercise testing and/or aerobic training, as determined by the attending oncologist:
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
  • Recurrent syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Symptomatic severe aortic stenosis
  • Uncontrolled heart failure
  • Acute (within 3 months) pulmonary embolus or pulmonary infarction
  • Thrombosis of lower extremities
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • Room air desaturation at rest <85%
  • Respiratory failure
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
  • Mental impairment leading to inability to cooperate.
  • Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >150 mmHg or diastolic blood pressure (DBP) of >90 mmHg].

Contact:

  • Julia Hurrelbrink, RN, BSN
  • 919-681-7460

Location:

  • Duke University Medical Center
  • Durham North Carolina 27710 United States

View trial on ClinicalTrials.gov


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BIOREN (Predictive BIOmarkers in Metastatic RENal Cancer) - A Translational Study on Immunotherapy for Metastatic Renal Cancer


Condition: Renal Cancer Metastatic

Intervention:

  • Biological: Immunological and tumour characterization

Purpose: The BIOREN project aims are to characterize the genetic background of renal cell carcinomas and their immune environment, to try and identify biomarkers of response and to better understand the mechanisms of resistance to nivolumab in renal cancer.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03628859

Sponsor: Centre Leon Berard

Primary Outcome Measures:

  • Measure: Evaluation of Tregs function on peripheral blood/neoplastic tissue from mRCC patients undergoing nivolumab treatment
  • Time Frame: Evolution of percentage of CD4+CD25+ CD127low FOXP3+ cells between inclusion and up to 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Evaluation of NK function/cytotoxicity on peripheral blood/neoplastic tissue from mRCC patients undergoing nivolumab treatment
  • Time Frame: Evolution between inclusion and up to 24 months
  • Safety Issue:
  • Measure: Exploration of the biological rationale for coupling CXCR4 antagonist with anti-PD-1 in in vivo models of renal cancer (mice models).
  • Time Frame: Up to 24 months
  • Safety Issue:
  • Measure: Identification of response biomarkers
  • Time Frame: Up to 24 months
  • Safety Issue:
  • Measure: Identification of biomarkers of response
  • Time Frame: Evolution between inclusion and up to 24 months
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: December 21, 2018

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Eligibility:

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

Inclusion Criteria:

  • Age ≥ 18 years-old.
  • Histology proven locally advanced (unresectable) or metastatic clear cell renal cell carcinoma (mccRCC).
  • Starting 2nd or 3rd line of treatment with nivolumab, everolimus, axitinib or cabozantinib as per summaries of product characteristics (SmPC).
  • Signed informed consent.

Exclusion Criteria:

  • Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements.
  • Pregnant or breastfeeding woman

Contact:

  • BLANC Ellen
  • +33 4.78.78.29.67

Location:

  • Centre Leon Berard
  • Lyon 69008 France

View trial on ClinicalTrials.gov


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A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma in the United Kingdom (UK)


Condition: Advanced Renal Cell Carcinoma

Purpose: Clinical experience with cabozantinib is limited in the UK and Ireland and there is anecdotal evidence of there being variability between clinicians in terms of where cabozantinib is used in the treatment pathway. The present study aims to collate and report the experiences of a sample of National Health Service (NHS) Trusts that enrolled patients onto the managed access programme. The study will describe the positioning of cabozantinib in the treatment pathway, associated clinical outcomes and characteristics of patients with advanced RCC receiving cabozantinib in this early clinical experience setting. The results will provide valuable information for collective learning on how to prescribe and manage cabozantinib and its optimal positioning in the patient pathway. Overall, the findings will contribute to a better understanding of how best to manage patients with advanced RCC in routine practice.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03696407

Sponsor: Ipsen

Primary Outcome Measures:

  • Measure: Positioning of cabozantinib in the treatment pathway
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Distribution of cabozantinib starting dose.
  • Time Frame: Baseline
  • Safety Issue:
  • Measure: Daily dose during treatment
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Proportion of patients with dose modifications
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Median time to first dose modification
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Distribution of reasons for dose modifications.
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Proportion of patients permanently discontinuing cabozantinib.
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Distribution of reasons for discontinuation of treatment
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Median duration of cabozantinib treatment (months)
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Distribution of relevant concomitant treatments
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib.
  • Time Frame: 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Distribution of RCC stage and histological type at initial RCC diagnosis
  • Time Frame: baseline
  • Safety Issue:
  • Measure: Time (months) from advanced RCC diagnosis to cabozantinib initiation.
  • Time Frame: baseline
  • Safety Issue:
  • Measure: Distribution of RCC stage at cabozantinib initiation.
  • Time Frame: baseline
  • Safety Issue:
  • Measure: Distribution of metastatic sites.
  • Time Frame: baseline
  • Safety Issue:
  • Measure: Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group
  • Time Frame: baseline
  • Safety Issue:
  • Measure: Progression Free Survival (PFS)
  • Time Frame: 3, 6, 9, 12, 18 and 24 months and median PFS.
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: 6, 12, 18 and 24 months
  • Safety Issue:
  • Measure: Objective Response Rate (ORR)
  • Time Frame: 3, 6, 9 and 12 months
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: December 20, 2018

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Eligibility:

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

Inclusion Criteria:

  • A diagnosis of advanced RCC
  • Prescribed cabozantinib as part of the Managed Access Programme (MAP) (alive or deceased at study data collection)
  • Aged ≥18 years at start of cabozantinib treatment.

Exclusion Criteria:

  • Decline or lack the capacity to consent for researcher access to their medical records (if living)
  • Hospital medical records are unavailable for review

Contact:

  • Ipsen Recruitment Enquiries

Locations:

  • Royal Sussex County Hospital
  • Brighton BN2 5BE United Kingdom
  • Addenbrooke's Hospital
  • Cambridge CB2 0QQ United Kingdom
  • Beatson West of Scotland Cancer Centre
  • Glasgow G12 0YN United Kingdom
  • Royal Surrey County Hospital
  • Guildford GU27XX United Kingdom
  • St Bartholomew's Hospital
  • London EC1A 7BE United Kingdom
  • The Christie Hospital
  • Manchester M20 4BX United Kingdom

View trial on ClinicalTrials.gov


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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

Intervention:

  • Biological: SHR-1210
  • Drug: Famitinib

Purpose: Phase II multi-chort, adaptive two-stage, open label, nonrandomized study. The aim of our study is to evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210(Camrelizumab) in combination with a small-molecule multikinase inhibitor Famitinib in subjects with advanced RCC/UC/CC/EC and recurrent OC. chort1: Renal Cell Carcinoma (RCC) chort2: Urothelial Carcinoma(UC) chort3: Ovarian Cancer (OC) chort4: Cervical Cancer (CC) chort5: Endometrial Cancer (EC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03827837

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Primary Outcome Measures:

  • Measure: Overall response rate (ORR)
  • Time Frame: Up to 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Duration of Response (DoR)
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Disease Control Rate (DCR)
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Time to objective response(TTR)
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Progression-free survival(PFS)
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Overall survival(OS)
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: 12-month survival rate
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: number of participants who experience an adverse event (AE)
  • Time Frame: From the first assignment of informed consent form up to 90 days after the last dose
  • Safety Issue:
  • Measure: serum SHR-1210 concentrations
  • Time Frame: From the first dose up to 30 days after the last dose
  • Safety Issue:
  • Measure: Positive rate of ADA
  • Time Frame: From the first dose up to 30 days after the last dose
  • Safety Issue:
  • Measure: Maximum Observed Plasma Concentration (Cmax)
  • Time Frame: Day 1 of cycle 3 (each cycle is 21 days)
  • Safety Issue:
  • Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
  • Time Frame: Day 1 of cycle 3 (each cycle is 21 days)
  • Safety Issue:
  • Measure: Apparent Oral Clearance (CL/F)
  • Time Frame: Day 1 of cycle 3 (each cycle is 21 days)
  • Safety Issue:

Estimated Enrollment: 265

Study Start Date: January 23, 2019

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.

Contact:

  • Quanren Wang, MD
  • (+86) 021-50118402

Location:

  • Huadong Hospital Affiliated to Fudan University
  • Shanghai Shanghai 200136 China

View trial on ClinicalTrials.gov


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Patients Characteristics, Treatment Utilization, Costs and Outcomes in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) Who Received at Least One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy in Taiwan


Condition: Renal Cell Carcinoma Metastatic, Renal Cell Carcinoma

Purpose: This is a retrospective cohort study aiming to collect data on patients' characteristics, resource utilization, adverse events management and calculate costs attributed to current treatments of advance RCC patients who have received at least one prior VEGF-targeted therapy in Taiwan from National Health Insurance (NHI) perspective.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03699579

Sponsor: Ipsen

Primary Outcome Measures:

  • Measure: Medication usage
  • Time Frame: From start point for 2.5 months
  • Safety Issue:
  • Measure: Treatment's duration
  • Time Frame: From start point for 2.5 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Cost of medication used
  • Time Frame: From start point for 2.5 months
  • Safety Issue:
  • Measure: Costs of adverse event management
  • Time Frame: From start point for 2.5 months
  • Safety Issue:
  • Measure: Frequency of health resource usage
  • Time Frame: From start point for 2.5 months
  • Safety Issue:
  • Measure: Cost of health resource usage
  • Time Frame: From start point for 2.5 months
  • Safety Issue:

Estimated Enrollment: 66

Study Start Date: March 2019

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Eligibility:

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

Inclusion Criteria:

  • Patients with confirmed diagnosis of clear-cell renal cell carcinoma
  • Patients with evidence of metastatic disease
  • Patients who have received at least one previous VEGFR-targeted therapy, i.e sunitinib, pazopanib or sorafenib
  • Patients who received care at the selected medical centers, utilizing the National Health Insurance (NHI) reimbursed system at the time of the disease

Exclusion Criteria:

  • Patients enrolled in any clinical trial involving anti-cancer therapy
  • Pregnant woman

Contact:

  • Ipsen Recruitment Enquiries

Locations:

  • National Taiwan University Hospital
  • Taipei 100 Taiwan
  • Taipei Veterans General Hospital
  • Taipei 112 Taiwan

View trial on ClinicalTrials.gov


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Effects of a Neuroscience-based Technique on Post-traumatic Stress Disorder Symptoms, Inflammation, and Survival in Cancer Patients Announced of a Palliative Disease Progression and Their Partners


Condition: Colorectal Cancer, Bladder Cancer, Prostate Cancer, Kidney Cancer, Advanced Sarcoma

Intervention:

  • Other: Memory structuring intervention + Vagal breathing
  • Other: support and attention (usual care)

Purpose: The diagnosis and treatment trajectory of cancer can constitute a traumatic event because these can be perceived as sudden, catastrophic and life threatening. One common mental disorder following traumatic events is post-traumatic stress disorder (PTSD), described as reexperiencing of the event (e.g., having intrusive thoughts), having avoidance of trauma memories, emotional numbing, and experiencing hyperarousal symptoms. To date, and to the best of the investigator's knowledge, few studies have focused on PTSD in advanced cancer, but the existing data show that these patients are at risk for experiencing PTSD symptoms. Among the early interventions for preventing PTSD in people confronted by traumatic events is group debriefing, the retelling of the event, receiving empathy and compassion, and being encouraged to express feelings. However, four meta-analyses found debriefing to be ineffective. A neuroscience-based and evidence-based alternative may be the Memory Structuring Intervention (MSI) that tries to shift trauma processing from a limbic, emotional and somatic level to a frontal-cortical, cognitive and verbal level of processing. The MSI tries to achieve this shift by teaching people confronted with traumatic events to chronologically organize the segments of the event, to verbally label feelings or somatic sensations rather than re-experience them, and to provide causal links between the event's segments and causality to their feelings and sensations Since in males, sympathetic responses were more predictive of PTSD than in females , parasympathetic activation may be needed to be added to the MSI, for men. A main branch of the parasympathetic response is the vagus nerve, whose non-invasive index is Heart Rate Variability (HRV). One way to increase HRV, and thus parasympathetic activation, is through vagal breathing (i.e., deep, paced breathing). Therefore, adding to the MSI deep vagal breathing (VB) to reduce sympathetic hyperactivity, may increase connectivity between the amygdala and the frontal cortex. This may also increase the emotional regulation possibly yielded by the MSI, however in both genders. The effects of the MSI + vagal breathing on PTSD symptoms and on prognosis in advanced cancer patients receiving announcement of terminal cancer have never been investigated. Furthermore, whether reduced inflammation and increased emotional regulation may account for such effects needs to be investigated at the fundamental level. This project reflects the merging of neuroscience, psychooncology and psychoneuroimmunology for better understanding and treating cancer patients, as well as their partners.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03652298

Sponsor: Centre Oscar Lambret

Primary Outcome Measures:

  • Measure: PCL-5 score measurement at at 3 months (+/- 2 weeks) by the patient
  • Time Frame: 3 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Evolution of PCL-5 score in the first 3 months in the patient
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: The quality of life (QoL) score of the patient: EQ-5D
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: Quality-adjusted life years (QALY) of the patient
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: Inflammation level in the patients
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: Emotion regulation in the patients
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: Overall survival of the patients
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: PCL-5 score improvement in the partner
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: PCL-5 score evolution in the partner
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: Quality of life of the partner: EQ-5D scale
  • Time Frame: 3 months
  • Safety Issue:
  • Measure: Emotion regulation
  • Time Frame: 3 months
  • Safety Issue:

Estimated Enrollment: 84

Study Start Date: July 25, 2018

Phase: Phase 4

Eligibility:

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

Inclusion Criteria:

  • Men or women aged over 18 years old;
  • Who received in the last 7 days the diagnosis of metastatic incurable bladder, prostate, kidney, colorectal or sarcoma cancer (including recurrence) during the announcement visit;
  • Whose life expectancy is estimated ≥ 6 months by their treating oncologist;
  • Who have a WHO performance score < 3 (to be coherent with the life expectancy);
  • Who have an albumin level > 30g/liter (patients with an acceptable state of nutrition);
  • Who are engaged in a couple relationship for at least 1 year;
  • Who gave their signed consent to participate in the study;
  • Who are covered by a social insurance.

Exclusion Criteria:

  • Patients diagnosed with cerebral metastases;
  • Patients with locally advanced cancer without metastases;
  • Patients with an advanced or metastatic cancer amenable to curative intent treatment;
  • Patients suffering from a psychological vulnerability that might alter their reasoning or judgment capacities;
  • Patients with a psychological or physical incapacity to answer the questionnaires, attested by the medical staff;
  • Patients under custodial sentence or under tutelage or protection of vulnerable adults

Contact:

  • Yori GIDRON, PhD
  • 03 20 41 72 05

Location:

  • Centre Oscar Lambret
  • Lille France

View trial on ClinicalTrials.gov


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A Phase 1/2 Dose Escalation and Expansion Study of Combination APL-501 or Nivolumab With APL-101 in Locally Advanced or Metastatic Hepatocellular and Renal Cell Carcinoma


Condition: Hepatocellular Carcinoma, Renal Cell Carcinoma

Intervention:

  • Biological: APL-501
  • Drug: APL-101
  • Biological: Nivolumab

Purpose: Study Design and Investigational Plan: This is an open-label Phase 1/2 study to assess the safety and tolerability of combination PD-1 inhibitor (APL-501 or nivolumab) administered concomitantly with c-Met inhibitor (APL-101), to determine the recommended Phase 2 dose of the combination, and to obtain preliminary efficacy in HCC or RCC subjects with advanced or metastatic disease that have not been previously treated with a PD 1 inhibitor or a c-Met inhibitor. HCC subjects will receive the combination APL-501 plus APL-101 while RCC subjects will receive the combination nivolumab plus APL-101. In Phase 1, mandatory archival or fresh tumor biopsies will be collected. In Phase 2, a mandatory fresh tumor biopsy will be required for study entry and another fresh biopsy will be collected between Cycles 2 and 4. The frequency of administration of PD-1 inhibitors will be every 2 weeks starting in Cycle 1 on Day 8 and Day 22 of a 35-day cycle with all subsequent cycles on Day 1 and Day 15 of 28-day cycles. APL-101 will be administered orally every 12 hours continuously on an empty stomach.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03655613

Sponsor: Apollomics (Australia) Pty. Ltd.

Primary Outcome Measures:

  • Measure: Dose Limiting Toxicities (Phase 1)
  • Time Frame: Cycle 1 (up to 35 days)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Adverse events
  • Time Frame: First dose up to 90 days post last dose (up to approximately 2 years)
  • Safety Issue:
  • Measure: Drug discontinuation due to adverse events
  • Time Frame: First dose up to 90 days post last dose (up to approximately 2 years)
  • Safety Issue:
  • Measure: Overall Response Rate
  • Time Frame: Duration of study, performed at baseline, then every 8 weeks until objective disease progression (up to approximately 2 years)
  • Safety Issue:
  • Measure: Time to Response
  • Time Frame: Duration of study, first dose to first response (up to approximately 2 years)
  • Safety Issue:
  • Measure: Progression Free Survival
  • Time Frame: Duration of study, performed at baseline, then every 8 weeks until objective disease progression at 6, 12, 18 and 24 months (up to approximately 2 years)
  • Safety Issue:
  • Measure: Overall Survival
  • Time Frame: Duration of study, performed every 8 weeks from enrollment to death from any cause at 6, 12, 18, 24 months (up to approximately 2 years)
  • Safety Issue:

Estimated Enrollment: 119

Study Start Date: September 5, 2018

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent.
  2. Men and women 18 years of age or older.
  3. Histologically confirmed advanced or metastatic hepatocellular carcinoma that progressed while receiving at least one previous line of systemic therapy, including sorafenib, or who are intolerant of or refused sorafenib treatment following progression on standard therapy including surgical and/or local regional therapies, or standard therapy considered ineffective, intolerable, or inappropriate or for which no effective standard therapy is available.
  4. Histologically confirmed advanced or metastatic renal cell carcinoma with clear cell component who received one or two prior lines of antiangiogenic therapy in addition to no more than three previous regimens of systemic therapy including cytokines and cytotoxic chemotherapy agents.
  5. Disease according to irRECIST that can be reliably and consistently followed.
  6. Documented disease progression during or after the last treatment regimen and within 6 months before study enrollment.
  7. Tumor amenable to tumor biopsy and subject agreeable to tumor biopsy at study entry and during therapy with study treatment.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-
  9. Acceptable organ function.

Exclusion Criteria:

  1. History of severe hypersensitivity to mAbs, excipients of the APL-501, nivolumab, or APL-1
  2. History of receiving treatment with any c-Met signaling pathway inhibitor (marketed or investigational agents).
  3. Prior therapy with anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways).
  4. Unwilling to swallow orally administered medication whole.
  5. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
  6. Documented and/or known history of human immunodeficiency virus (HIV) for HCC and RCC subjects, or historical seropositive results consistent with active infection for hepatitis C virus (HCV) or hepatitis B virus (HBV) (RCC only).
  7. HCC subjects receiving active antiviral therapy for HCV.
  8. Active co-infection with HBV and HCV.
  9. Active co-infection with HBV and hepatitis D virus.

Contact:

  • Shelly Nigam, MS
  • 925.272.4090

Locations:

  • Crown Princess Mary Cancer Centre
  • Westmead New South Whales 2145 Australia
  • Ashford Cancer Center
  • Adelaide South Australia 5037 Australia
  • Royal Melbourne Hospital
  • Melbourne Victoria 3050 Australia
  • Sunshine Hospital
  • Saint Albans Victoria 3021 Australia
  • Fiona Stanley Hospital
  • Murdoch Western Australia 6150 Australia
  • Afffinity Clinical Research
  • Perth Western Australia 6018 Australia
  • Auckland City Hospital
  • Auckland 1023 New Zealand

View trial on ClinicalTrials.gov


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A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients Undergoing Nephrectomy for Locally-Advanced Clear Cell Renal Cell Carcinoma


Condition: Clear Cell Renal Cell Carcinoma

Intervention:

  • Drug: Sitravatinib
  • Drug: Nivolumab

Purpose: The study will evaluate the clinical activity of nivolumab in combination with the investigational agent sitravatinib in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the pre-surgical setting.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03680521

Sponsor: Mirati Therapeutics Inc.

Primary Outcome Measures:

  • Measure: Percentage of patients achieving a point in time objective response (either complete or partial response [CR or PR]) prior to surgery.
  • Time Frame: 6-8 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Number of patients experiencing adverse events (number and percent of patients reporting AEs)
  • Time Frame: 12 weeks
  • Safety Issue:

Estimated Enrollment: 25

Study Start Date: September 24, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Imaging results consistent with locally-advanced RCC
  2. Candidate for partial or complete nephrectomy as part of treatment plan.
  3. Measurable disease as per RECIST version 1.
  4. ECOG performance status 0 or
  5. Adequate bone marrow and organ function.

Exclusion Criteria:

  1. Prior systemic anti-tumor treatment for RCC.
  2. Patients who are receiving any other investigational agents.
  3. Clinical status indicating that immediate surgery (within 6 weeks) is warranted regardless of whether neoadjuvant therapy is to be administered, as assessed by the treating surgeon.
  4. Inability to undergo baseline tumor biopsy.
  5. Active or prior documented autoimmune or immunocompromising conditions.
  6. Uncontrolled hypertension.

Contact:

  • Mirati Therapeutics
  • 844-893-5530

Location:

  • MD Anderson Cancer Center
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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Development and Evaluation of High Risk Group Prediction Model in T1 Stage Renal Cell Cancer Using Molecular Biomarkers


Condition: Clear Renal Cell Cancer (< 7cm Size)

Intervention:

  • Procedure: Partial or radical nephrectomy

Purpose: For the appropriate individualized treatment of T1-stage renal cell carcinoma with heterogeneous biological features, the expression of PBRM1, SETD2, BAP1, KDM5C and the newly proposed FOXC2 and CLIP4, are compared with clinical features. The investigators evaluated the efficacy of FOXC2 and CLIP4 as prognostic biomarkers and developed a high risk prediction model based on these results. In a previous study, the investigators evaluated the efficacy of FOXC2 and CLIP4 as prognostic biomarkers and reported their association with synchronous metastasis in renal cell carcinomas less than 7 cm in size. The investigators analyzed the expression level of renal cell carcinoma according to the size and malignancy (Fuhrman grade) of renal cell carcinoma in T1-stage clear cell type renal cell carcinoma of tumor size less than 7cm. The aim of this study was to analyze the association of tumor recurrence or metastasis, cancer specific survival rate, overall survival rate, tumor size, malignancy and T stage in postoperative biopsy. For expression analysis, PCR amplification and bidirectional Sanger sequencing and mRNA expression analysis (qRT-PCR) were used. For statistical analysis, Fisher exact test, Wilcoxon exact 2-tailed test, Cox proportional hazard regression analysis and competing risk method were used. In this study, the investigators compared the expression of PBRM1, SETD2, BAP1, and KDM5 with newly proposed biomarkers, FOXC2 and CLIP4 and demonstrate the prognostic value of FOXC2 and CLIP4 as new prognostic biomarkers and compared the clinical outcomes with the clinical outcome. Based on these results, the investigators propose a high risk prediction model for individualized treatment of T1-stage renal cell carcinoma. This study is expected to establish a new prediction model and molecular biologic stage for risk stratification of T1-stage renal cell carcinoma patients and apply genetic test for selection of optimal tailored treatment for T1-stage renal cell carcinoma. In addition, it will be an important basic data of the molecular biologic mechanism of metastasis in early renal cell carcinoma and may be used as a basic data for the development and selection of customized therapeutic agents in patients with distant metastasis.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03694912

Sponsor: Yonsei University

Primary Outcome Measures:

  • Measure: Assessment of gene expression of biomarkers using reverse-transcription polymerase chain reaction (qRT-PCR) according to groups
  • Time Frame: 1 week after the procedure
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: association of tumor size
  • Time Frame: 1 week after the procedure
  • Safety Issue:
  • Measure: association of tumor malignancy
  • Time Frame: 1 week after the procedure
  • Safety Issue:

Estimated Enrollment: 426

Study Start Date: November 1, 2018

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Eligibility:

  • Age: minimum 20 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Patients diagnosed as clear cell renal cell caner T1 stage
  • Patients who have undergone partial or radical nephrectomy in Severance Hospital, Sinchon from 2018.11 and 2019.10
  • Those who agree to give permission to use their human source information
  • Those who agree with this study

Exclusion Criteria:

  • Vulnerable Participants
  • Those who don't agree with this study

Location:

  • Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
  • Seoul 03722 Korea, Republic of

View trial on ClinicalTrials.gov


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Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors


Condition: Renal Tumor

Intervention:

  • Radiation: Stereotactic Ablative Radiotherapy

Purpose: Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03747133

Sponsor: University Health Network, Toronto

Primary Outcome Measures:

  • Measure: To evaluate the radiation induced renal impairments in patients receiving SABR.
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Chronic Kidney Disease Stage Progression
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: 2-year Local recurrence rate
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Patient Reported Outcomes
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Incidence of acute and late toxicities
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: November 1, 2018

Eligibility:

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

Inclusion Criteria:

  • Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm
  • Histological or radiological diagnosis of renal tumor
  • Inoperable: High risk for surgery or declined surgery
  • ECOG performance status of 0-3

Exclusion Criteria:

  • ≥5 active metastases
  • Sysstemic therapy (except endocrine therapy) wthin 6 days prior to SABR
  • Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney
  • Patients with end stage renal failure > 4(KDOQI guidelines)
  • Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis

Contact:

  • Joelle Helou, MD
  • 416-946-4501 Ext. 4866

Locations:

  • Royal Victoria Regional Health Centre
  • Barrie Ontario L4M 6M2 Canada
  • University Health Network - Princess Margaret Cancer Centre
  • Toronto Ontario M5G 2M9 Canada

View trial on ClinicalTrials.gov


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Phase II Trial of AZD6738 Alone and in Combination With Olaparib in Patients With Selected Solid Tumor Malignancies


Condition: Clear Cell Renal Cell Carcinoma, Locally Advance Pancreatic Ductal Adenocarcinoma, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Metastatic Renal Cell Carcinoma, Metastatic Urothelial Carcinoma, Pancreatic Ductal Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

Intervention:

  • Drug: ATR Kinase Inhibitor AZD6738
  • Drug: Olaparib

Purpose: This phase II trial studies how well ATR kinase inhibitor AZD6738 works alone or in combination with olaparib in treating participants with renal cell carcinoma, urothelial carcinoma, pancreatic ductal adenocarcinoma, or other solid tumors that have spread to nearby tissue or lymph nodes or other parts of the body. ATR kinase inhibitor AZD6738 and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not known if giving ATR kinase inhibitor AZD6738 with or without olaparib may work better in treating participants with solid tumors.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03682289

Sponsor: University of California, San Francisco

Primary Outcome Measures:

  • Measure: Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Time Frame: Up to 2.5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Median duration of response (DOR)
  • Time Frame: Up to 2.5 years
  • Safety Issue:
  • Measure: Median progression-free survival (PFS)
  • Time Frame: At 6 months
  • Safety Issue:
  • Measure: Median PFS
  • Time Frame: At 12 months
  • Safety Issue:
  • Measure: PFS rate
  • Time Frame: At 6 months
  • Safety Issue:
  • Measure: PFS rate
  • Time Frame: At 12 months
  • Safety Issue:
  • Measure: Incidence of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  • Time Frame: Up to 30 days post treatment
  • Safety Issue:

Estimated Enrollment: 68

Study Start Date: January 17, 2019

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patients must provide written informed consent prior to performance of study-specific procedures or assessments.
  • Histologically confirmed locally advanced or metastatic solid tumor malignancy with by tumor type as specified below:
  • Renal cell carcinoma with clear cell component (Cohort A): Patients must have prior progression on or following, intolerance of, or patient refusal to receive VEGF-targeting tyrosine kinase inhibitor and immune checkpoint blockade.
  • Urothelial carcinoma (Cohort B). Patients must have prior progression on or following, intolerance of, or patient refusal to receive platinum chemotherapy and immune checkpoint blockade.
  • Pancreatic ductal adenocarcinoma (Cohort C). Patients must have prior progression on or following, intolerance of, or patient refusal to receive fluorouracil (5-FU), gemcitabine, and irinotecan-based chemotherapy.
  • Other solid tumors excluding clear cell ovarian cancer (Cohort D). Patients must have prior progression on or following, intolerance of, of patient refusal of at least one systemic therapy for locally advanced or metastatic disease and must not have any curative treatment options available.
  • Evidence of clinical or radiographic progression prior to study entry.
  • Formalin-fixed paraffin embedded tumor tissue evaluable for BAF250a expression by immunohistochemistry. Primary or metastatic tumor tissue is permissible. Patients without evaluable archival tissue may undergo optional tumor biopsy during Screening if other

Eligibility Criteria:

  • have been met.
  • Measurable disease by RECIST 1.1.
  • Resolution of all prior treatment-related toxicities to grade 1 severity or lower (except alopecia).
  • Patients must be at least 3 weeks or 5 half-lives (whichever is shorter) from last standard or experimental non-cytotoxic therapy prior to first dose of protocol therapy. Patients must be > 21 days from last dose of cytotoxic chemotherapy prior to C1D1. The minimum wash-out period for immunotherapy is 42 days prior to C1D1.
  • Radiation therapy must be completed > 7 days prior to course 1 day 1 (C1D1) or > 28 days prior to C1D1 for patients receiving radiation to more than 30% of bone marrow.
  • Hemoglobin (Hgb) >= 10.0 g/dL in the absence of transfusion within 14 days prior to screening laboratory assessment.
  • Platelets (Plt) count > 100,000 x 10^9/L.
  • Absolute neutrophil count > 1.5 x 10^9/L.
  • Estimated glomerular filtration rate (GFR) >= 51 ml/min based on Cockcroft-Gault equation or 24 hour urine collection.
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) (< 5x ULN in patients with known liver metastases).
  • Total bilirubin < 1.5 x ULN (direct bilirubin < 1.5 x ULN in patients with known Gilbert?s disease or UGT1A1 homozygote).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The effects of AZD6738 and olaparib on the developing human fetus are unknown. For this reason and because ATR and PARP inhibitors as well as other therapeutic drugs used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use 2 highly effective forms of contraception 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.
  • Male patients who are sexually active must be willing to use barrier contraception for the duration of the study and for 1 week after the last study drug administration, with all sexual partners. Male patients must use a condom during treatment and for 6 months after the last dose of study drug(s) 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 for 6 months after the last dose of study drug(s) if they are of childbearing potential. True abstinence for either sex is an acceptable form of contraception and must be documented as such.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to C1D1 treatment). Evidence of postmenopausal status or non-child bearing status must be documented. Postmenopausal is defined as:
  • Aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
  • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation, radiation-induced oophorectomy with last menses > 1 year ago, chemotherapy-induced menopause with > 1 year interval since last menses
  • Amenorrhoeic for 12 months and serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and plasma oestradiol levels in the postmenopausal range for the institution for women under 50.
  • Ability to understand a written informed consent document, and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.

Exclusion Criteria:

  • History of secondary malignancy requiring treatment within 1 year prior to screening, with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, low/intermediate risk localized prostate cancer (=< Gleason 7, =< T2N0M0, and prostate-specific antigen (PSA) =< 20 ng/mL at diagnosis), ductal carcinoma in situ, stage I uterine cancer, and non-muscle invasive urothelial carcinoma.
  • Patients receiving, or having received within 14 days of C1D1, corticosteroids at a dose > 10 mg/day of prednisone (or equivalent).
  • Patients with myelodysplastic syndrome or features suggestive of myelodysplastic syndrome.
  • Prior treatment with ATR or PARP inhibitor (e.g. olaparib, rucaparib, niraparib).
  • Major surgical procedures < 28 days prior to C1D1. Patients must have recovered to grade =< 1 for any adverse events related to the surgical procedure.
  • Untreated central nervous system (CNS) metastases. Patients with previously treated central nervous system (CNS) metastases are eligible if:
  • No requirement for corticosteroids at study entry
  • Radiographically and clinically stable for at least 4 weeks prior to study entry
  • No evidence of intra-tumoral hemorrhage
  • No evidence of current or prior leptomeningeal disease.
  • Clinically significant gastrointestinal abnormalities that may increase the risk of decreased absorption of medications, including:
  • Inability to swallow oral medications
  • Active peptic ulcer disease
  • Known intra-luminal metastatic lesions
  • History of abdominal fistula or bowel perforation
  • History of bowel obstruction within 6 months prior to study entry
  • Known malabsorption syndrome
  • Significant resection of the small bowel.
  • Fridericia's QT correction formula (QTcF) > 470 ms (females) or > 450 ms (males) on screening electrocardiography (ECG), or immediate family history of congenital long QT syndrome or sudden cardiac death at age less than 40.
  • History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Myocardial infarction
  • Unstable angina Transient ischemic attack or cerebrovascular accident
  • Uncontrolled arrhythmia. Rate controlled atrial fibrillation/flutter is not an exclusion for the study.
  • Class III or IV congestive heart failure or documented left ventricle (LV) ejection fraction of < 50% (screening not required).
  • Uncontrolled hypertension as defined by systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 100 mm Hg. Adjustment of anti-hypertensive regimen and re-screening is permitted.
  • Relative hypotension with resting blood pressure < 90/60 mm Hg or symptomatic orthostatic hypotension.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient?s safety or adherence to study procedures including uncontrolled infection requiring parenteral antibiotics.
  • Concomitant use of strong CYP3A4 inhibitors, strong CYP3A4 inducers, CYP3A4 substrates with narrow therapeutic index, or CYP2B6 substrates with narrow therapeutic index within 21 days or 5 half-lives, whichever is shorter, prior to C1D1 of study treatment
  • The use of herbal supplements or ?folk remedies? (and medications and foods that significantly modulate CYP3A activity) should be discouraged. If deemed necessary, such products may be administered with caution and the reason for use documented in the case report form (CRF).
  • A known hypersensitivity to olaparib, AZD6738 or any excipient of the product or any contraindication to the combination anti-cancer agent as per local prescribing information.
  • Known chronic active hepatitis B or C (defined by positive viral load; screening not required).
  • Immunocompromised patients, including those serologically positive for human immunodeficiency virus (HIV), those receiving chronic immunosuppression, or those with prior allogeneic or cord blood transplantation.

Contact:

  • Rahul Aggarwal
  • 877-837-3222

Location:

  • UCSF Medical Center-Mount Zion
  • San Francisco California 94115 United States

View trial on ClinicalTrials.gov


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A Phase I/II Open Label, Safety And Preliminary Efficacy Study of MRx0518 In Combination With Pembrolizumab In Patients With Advanced Malignancies Who Have Progressed On PD-1 Inhibitors


Condition: Oncology, Solid Tumor, Non Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma, Bladder Cancer

Intervention:

  • Drug: MRx0518
  • Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

Purpose: This is a single center, open label, safety and preliminary efficacy study of MRx0518 in combination with pembrolizumab in patients with solid tumours (non small cell lung cancer, renal cell carcinoma, bladder cancer or melanoma). Subjects will be treated with IV pembrolizumab every 3 weeks and 1 capsule twice daily of MRx0518. Treatment will continue as long as clinically relevant, until disease progression, unacceptable AEs or withdrawal of consent up to a maximum of 35 cycles (approx. 2 years).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03637803

Sponsor: 4D pharma plc

Primary Outcome Measures:

  • Measure: Part A: To assess the safety and tolerability of MRx0518 in combination with pembrolizumab through the collection of adverse events
  • Time Frame: Baseline to treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days)
  • Safety Issue:
  • Measure: Part B: To assess safety and tolerability of MRx0518 in combination with pembrolizumab through the collection of adverse events
  • Time Frame: Baseline to treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days)
  • Safety Issue:
  • Measure: Part B: To assess the clinical benefit of MRx0518 in combination with pembrolizumab
  • Time Frame: Baseline to treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Antitumour effect
  • Time Frame: Baseline and every 3 weeks until treatment discontinuation up to a maximum of 35 treatment cycles (one cycle = 21 days)
  • Safety Issue:

Estimated Enrollment: 132

Study Start Date: January 10, 2019

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • Willing and able to provide written informed consent/assent for the trial.
  • ≥18 years of age on day of signing informed consent.
  • Histological or cytological evidence of advanced and/or metastatic or recurrent NSCLC, renal cell carcinoma, bladder cancer or melanoma.
  • At least one measurable lesion per RECIST v 1.1 criteria.
  • Failure to respond or intolerance to standard therapy or for whom no appropriate therapies are known to provide clinical benefit (per the judgement of the Investigator).
  • Subjects must have progressed on treatment with a PD-1 inhibitor administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 inhibitor treatment progression is defined by meeting all of the following criteria: 1. Has received at least 2 doses of a PD-1 inhibitor. 2. Has demonstrated disease progression after PD-1 therapy as defined by RECIST v1.1, iRECIST or irRECIST. The initial evidence of disease progression (PD) is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression. 3. Progressive disease has been documented within 12 weeks from the last dose of a PD-1 inhibitor.
  • Have adequate organ function
  • Be willing to provide archival tissue
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥2 years.
  • 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 study medication
  • Male subjects with female partners of childbearing potential 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.

Exclusion Criteria:

  • Subjects who failed to show any response to initial treatment with PD-1 inhibitor (i.e. no Response or no Stable Disease).
  • Has active brain metastases or leptomeningeal disease. Subjects with asymptomatic CNS metastases which have been stable (defined as without evidence of progression by MRI for at least 28 days prior to initiation of therapy and any neurologic symptoms have returned to baseline) following treatment with surgery or radiation therapy are allowed.
  • Prior solid organ or hematologic transplant.
  • Treatment-related immune-mediated (or immune related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 agents, anti-CTLA4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were grade 3 or 4 in severity.
  • Subjects treated with chemotherapy, immunotherapy, biologic therapy, or other investigational agent within <5 times the half-life of the agent or <21 days (whichever is shorter) of starting study drug. Continuation of hormone replacement therapy is permitted. Stable regimens of hormonal therapy i.e. for prostate cancer (e.g. leuprolide, a GnRH agonist), ovarian, or breast cancer are not exclusionary.
  • Subjects treated with tyrosine kinase inhibitor therapy or completed palliative radiotherapy <14 days from initiation of therapy.
  • Comorbidity requiring corticosteroid therapy (>10mg prednisone/day or equivalent) within 7 days of starting experimental therapy. Physiologic replacement doses are allowed if they are ≤10mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.
  • Significant cardiac dysfunction

Contact:

  • Gayle Fyvie
  • +447741893670

Location:

  • MD Anderson Cancer Center
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Evaluating the Use of Perioperative Intravenous Lidocaine Infusion to Decrease Pain Scores and Opioid Consumption After Robotic-Assisted Prostatectomy and Robotic-Assisted Partial Nephrectomy


Condition: Kidney Cancer, Prostate Cancer

Intervention:

  • Drug: Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution
  • Drug: 0.9% Sodium Chloride Injection

Purpose: Controlling pain is fundamental during and after surgical procedures. This study examines pain associated with robotic assisted surgery on prostate cancer or a kidney mass. In recent years, the risk of opioids in the postoperative period has gained interest due to the growing epidemic of addiction, dependence, and overdose. In this study, the investigators expect a continuous infusion of intravenous lidocaine during the perioperative period to result in less pain and less opioid use.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03824808

Sponsor: University of Missouri-Columbia

Primary Outcome Measures:

  • Measure: Difference in post-operative pain scores measured by Visual Analog Scale
  • Time Frame: Through study completion, assessed up to 14 days (+/-) 7 days
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Opioid consumption
  • Time Frame: Through study completion, assessed up to 14 days (+/-) 7 days
  • Safety Issue:
  • Measure: Length of hospital stay
  • Time Frame: At participant discharge, assessed up to 14 days (+/-) 7 days
  • Safety Issue:
  • Measure: Duration of post-operative Ileus
  • Time Frame: During hospitalization, assessed up to 14 days (+/-) 7 days
  • Safety Issue:
  • Measure: Post-operative PACU time
  • Time Frame: During hospitalization, approximately 2 hours post-surgery
  • Safety Issue:
  • Measure: Return of flatus
  • Time Frame: During hospitalization, assessed up to 14 days (+/-) 7 days
  • Safety Issue:
  • Measure: Time to out of bed
  • Time Frame: During hospitalization, assessed up to 14 days (+/-) 7 days
  • Safety Issue:
  • Measure: First ambulation in the hallway
  • Time Frame: During hospitalization, assessed up to 14 days (+/-) 7 days
  • Safety Issue:

Estimated Enrollment: 40

Study Start Date: February 26, 2019

Phase: Phase 4

Eligibility:

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

Inclusion Criteria:

  • Undergoing robotic assisted prostatectomy or robotic assisted partial nephrectomy at University of Missouri Hospital for prostate cancer or kidney mass
  • Age ≥ 18 years
  • ASA I-III

Exclusion Criteria:

  • Inability to obtain written informed consent
  • Allergy to lidocaine or other amide local anesthetics
  • Atrioventricular conduction blocks
  • CV instability and concomitant use of alpha agonists or beta blockers
  • Recent myocardial infarction (≤ 6 months ago)
  • Cardiac arrhythmia disorders
  • Stokes-Adams syndrome
  • Wolff-Parkinson-White syndrome
  • Seizure disorders
  • Liver failure or hepatic dysfunction
  • Significant renal disease with a serum creatinine ≥ 2 mg/dl
  • A family history of malignant hyperthermia
  • Current use of opioids or documented history of opioid abuse
  • Typically, have less than 3 bowel movement per week
  • Combined surgical cases that include robotic prostatectomy or robotic partial nephrectomy

Contact:

  • Katie Murray, DO
  • 573-884-4057

Location:

  • University Hospital
  • Columbia Missouri 65212 United States

View trial on ClinicalTrials.gov


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