Kidney/Renal Cancer

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A Phase 1/1b Study of Sitravatinib in Combination With Nivolumab and Ipilimumab in Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies


Condition: Clear-Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04518046

Sponsor: Mirati Therapeutics Inc.

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Confirmed diagnosis of Clear-Cell Renal Cell Carcinoma (for initial cohorts under consideration)
  • No prior treatment with systemic therapy (for initial cohorts under consideration)
  • Adequate bone marrow and organ function

Exclusion Criteria:

  • Known or suspected presence of other cancer
  • Brain metastases (for initial cohorts under consideration)
  • Carcinomatous meningitis
  • Immunocompromising conditions
  • Impaired heart function
  • Active or prior documented autoimmune disease

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A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment


Condition: Carcinoma, Renal Cell

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04338269

Sponsor: Hoffmann-La Roche

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.
  • Radiographic disease progression during or following treatment with ICI for locally advanced or metastatic RCC either in first- or second-line treatment. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed.
  • Measurable disease per RECIST v1.1
  • Evaluable IMDC risk score
  • Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible. Both archival and fresh samples are preferred.
  • KPS score of >=70
  • Recovery to baseline or Grade
  • Adequate hematologic and end-organ function
  • Negative HIV test at screening
  • Negative hepatitis B testing at screening
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

  • Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment
  • Patients received cabozantinib at any time prior to screening
  • Patients who received more than one ICI treatment in the locally advanced or metastatic setting
  • Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting
  • Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting
  • Symptomatic, untreated, or actively progressing CNS metastases
  • History of leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1
  • Active tuberculosis
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety
  • Pharmacologically uncompensated, symptomatic hypothyroidism
  • Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment
  • Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
  • History of congenital QT syndrome
  • History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
  • Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)

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A Phase 2 Study of Neoadjuvant Cabozantinib in Patients With Locally Advanced Non-Metastatic Clear Cell Renal Cell Carcinoma


Condition: Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04022343

Sponsor: Emory University

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patients with renal mass consistent with a clinical stage ≥ T3Nx or TanyN+ or deemed unresectable by surgeon.
  • Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Patients must have adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:
  • Absolute neutrophil count (ANC) ≥ 1500/mm³ (≥ 1.5 GI/L) without granulocyte colony-stimulating factor support.
  • White blood cell count ≥ 2500/mm³ (≥ 2.5 GI/L).
  • Platelets ≥ 100,000/mm³ (≥ 100 GI/L) without transfusion.
  • Hemoglobin ≥ 9 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.
  • Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN).
  • Serum albumin ≥ 2.8 g/dl.
  • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 mL/min (≥ 0.67 mL/sec) using the Cockcroft-Gault equation:
  • Males: (140
  • age) x weight (kg)/(serum creatinine [mg/dL] × 72)
  • Females: [(140
  • age) x weight (kg)/(serum creatinine [mg/dL] × 72)] × 0.85
  • Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol).
  • No hormonal therapy, chemotherapy, immunotherapy, or any other systemic therapy for a malignancy, in the 5 years prior to current study enrollment.
  • 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 4 months after the last dose of study treatment.
  • 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:

  • Evidence of metastatic disease on pre-treatment imaging.
  • The subject has received of any type of cytotoxic, biologic or other systemic anticancer therapy for kidney cancer.
  • The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
  • Known brain metastases or cranial epidural disease.
  • 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.
  • The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test ≥ 1.3 × the laboratory ULN within 14 days before the first dose of study treatment.
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders:
  • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
  • Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment.
  • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before first dose.
  • Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
  • The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, active inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.
  • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose.
  • Clinically significant 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.
  • 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).
  • 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, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
  • Prolongation of the QT corrected for HR using Fridericia's method (QTcF) interval defined as > 500 msec 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.
  • Pregnant or lactating females.
  • Inability to swallow tablets.
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations.
  • 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. Patients with Gleason 6 (3+3) prostate cancer with previous treatment or on active surveillance may also be allowed on protocol.

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Talazoparib and Avelumab in Genomically Defined Metastatic Renal Cell Carcinoma


Condition: Metastatic Renal Cell Carcinoma, Fumarate Hydratase Deficient Renal Cell Carcinoma, Succinate Dehydrogenase Deficient Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04068831

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Biopsy proven, histological confirmed renal cell carcinoma (RCC) or renal medullary carcinoma (RMC).. Patients with surgery and biopsy at outside institutions will be eligible for this protocol once archival material is reviewed and the above diagnosis confirmed by genitourinary pathology review at Memorial Sloan Kettering Cancer Center (MSKCC). Cohort 1:
  • Presence of VHLalteration by next-generation sequencing (NGS) with a stateapproved assay
  • Patients must have radiographic evidence of disease progression after treatment with at least one prior PD-1 or PD-L1 agent, and one prior VEGF inhibitor
  • Maximum 3 prior lines of therapy Cohort 2:
  • For FH/SDH patients FH- or SDH- expression-loss by immunohistochemistry (IHC) or alteration (somatic or germline) in FH or SDH per NGS with a state-approved assay
  • For Renal Medullary Carcinoma (RMC) patients: histologic confirmation of RMC (no IHC/NGS criteria required)
  • At least one prior line of therapy:
  • For FH/SDH patients Patients must have radiographic evidence of disease progression after treatment with at least one prior line of therapy (one prior PD-1/PD-L1 and/or VEGF inhibitor).
  • For Renal Medullary Carcinoma (RMC) patients prior radiographic evidence of disease progression on/after at least one line of chemotherapy (e.g. carboplatin / paclitaxel, carboplatin / paclitaxel / bevacizumab, carboplatin / gemcitabine, and gemcitabine / doxorubicin).
  • No maximum lines of therapy Both Cohorts 1 & 2
  • Adequate Hematologic Function
  • Absolute Neutrophil Count ≥ 1.5 x 10^9 / L
  • Platelet Count ≥ 100 x 10^9 / L
  • Hemoglobin ≥ 9 g/dL
  • No transfusion of packed red blood cells or platelets within 21 days of Cycle 1 Day 1
  • Adequate Renal Function ≥ 30 ml/min according to the Cockcroft-Gault Equation
  • Patients with moderate renal impairment (creatinine clearance 30-59 by Cockcroft-Gault EquationI) will start with a reduced dose of talazoparib.
  • Adequate Hepatic Function including:
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST ≤ 3 x upper limit of normal (ULN) without liver metastasis
  • ALT ≤ 3 x upper limit of normal (ULN) without liver metastasis
  • AST or ALT ≤ 5 x upper limit of normal (ULN) for patients with liver metastasis
  • Patients with known Gilbert's syndrome may be included if total bilirubin ≤ x 3 ULN
  • Eastern Cooperative Group (ECOG) Performance Status 0-2.
  • Patients must have measurable disease by RECIST v1.1. At least one measurable lesion should not have been previously irradiated.
  • Women of childbearing potential must have negative serum pregnancy testing at screening. All women will be considered childbearing potential unless meeting criteria including:
  • Achieved post-menopausal status as defined by cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have follicular stimulation hormone showing postmenopausal state. Women who have been amenorrhoeic for ≥12 months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anorexia, low body weight, ovarian suppression, anti-estrogen therapy or other medically inducible reasons.
  • Documented hysterectomy or bilateral oophorectomy surgery
  • Medically confirmed ovarian failure
  • Sexually active participants and their partners must agree to use medically accepted methods of contraception (i.e. barrier methods including condoms, female condom, or diaphragm with spermicidal gel) during the study and for 7 months after the last dose of the study treatment for females, and 4 months for males.
  • Recovery of baseline CTCAE v5.0 grade ≤1 toxicities related to prior study treatments unless adverse events are clinically non-significant and/or stable on supportive therapy if needed.
  • Patients must be willing and able to comply with trial protocol. This includes adhering to the treatment plan, scheduled visits, laboratory and other study procedures.

Exclusion Criteria:

  • Patients < 18 years old
  • Patients who are pregnant or breast-feeding. Fertile patients who are unwilling or unable to use two methods of contraception (at least one of which considered highly effective) for duration of study and after 7 months after last dose of study treatment for female, and 4 months for males.
  • Patients who had prior immune checkpoint blockade therapy (either anti-PD-1, anti- PD-L1 and/or anti-CTLA-4) discontinued due to development of an immune related adverse event.
  • Prior diagnosis of myelodysplastic syndrome (MDS) or diagnosis of other malignancy that requires anti-cancer directed therapy within the last 24 months. Exclusions include those cancers that are considered cured by local therapy (i.e.Basal cell carcinoma, squamous cell carcinoma, ducal carcinoma in situ of breast, bladder of cervix) or other cancers that have low malignant potential and do not require systemic therapy (i.e. Gleason-grade <6 prostate adenocarcinoma, borderline ovarian malignancy / low malignant potential).
  • Prior treatment with talazoparib or other agents that target PARP
  • Treatment with anti-cancer therapies within 21 days or five half-lives, whichever shorter, of start date, including monoclonal antibody, cytotoxic therapy, or another investigational agent. There is no specific time window between last PD-1/PD-L1 therapy and start date of new therapy on protocol.
  • Significant vascular disease (i.e. aortic aneurysm requiring surgical repair, recent arterial thrombosis) within 6 months prior to first dose of therapy.
  • Evidence of bleeding diathesis or significant unexplained coagulopathy (i.e. absent of anticoagulation)
  • Clinical signs or symptoms of gastrointestinal obstruction requirement parenteral hydration, parenteral nutrition, or feeding tube.
  • Uncontrolled effusion management (pleural effusion, pericardial effusion, or ascites) which requires recurrent drainage procedures.
  • Patients treated with systemic immunosuppressants; except for 1. chronic physiologic replacement of ≤ 10mg prednisone (or equivalent) for treatment of adrenal insufficiency; Steroids required for pre-medication reactions 2. Local steroid use is permitted (e.g. intranasal, topical, inhaled, or local steroid injection, i.e. intra-articular)
  • Patients with autoimmune disease that may worsen during immune checkpoint blockade therapy are excluded. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requirement immunosuppressive treatment as above are eligible.
  • Prior organ transplantation including allogeneic stem cell transplant.
  • No active infection requiring parenteral antibiotic therapy.
  • Prior diagnosis of HIV/AIDS
  • History of either positive HCV RNA viral load or anti-HCV antibody screening detectable; HBV infection with HBV surface antigen detection and/or positive HBV DNA viral load.
  • Known hypersensitivity to talazoparib or avelumab, or any component in formulations. Patients with known hypersensitivity to monoclonal antibodies (Grade ≥3 by CTCAE v5.0)
  • Live vaccination within 4 weeks of first dose of therapy. All vaccines except inactivated are prohibited while on study.
  • Severe acute or chronic medical conditions which may significantly increase the risk of study participants, per treating investigator's discretion
  • Radiation therapy to any site (including bone) <2 weeks prior to the first dose of therapy. Patients with clinically relevant ongoing complications from prior radiation therapy, per investigators' assessment, are not eligible.
  • Symptomatic brain metastasis or leptomeningeal disease requiring steroid use. Patients are eligible if they neurologically stable for 4 weeks, and have completed radiation therapy or surgery, and recovered from side effects. Patients must have discontinued steroid therapy for at least 2 weeks prior to first dose of study treatment.
  • Current or anticipated use of potent P-gp inhibitors within 7 days prior to randomization or anticipated use during the study. Please see Appendix 5 for a list of potent P-gp inhibitors.
  • Inability to swallow capsules, known intolerance to talazoparib or its excipients, known malabsorption syndrome, or other conditions which impair intestinal absorption.
  • Investigator site staff members directly involved in study conduct, including but not limited to their family members, or patients who are Pfizer members, including their family members, who are directly involved in study conduct.

View trial on ClinicalTrials.gov


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Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study


Condition: Advanced Renal Cell Carcinoma (All Subtypes), Metastatic Renal Cell Carcinoma (All Subtypes)

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04147143

Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Phase:

Eligibility:

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

Inclusion Criteria:

  1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject
  2. Patients with advanced or metastatic renal cell carcinoma, including all subtypes
  3. Age ≥ 18 years
  4. Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment

Exclusion Criteria:

  1. Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial
  2. Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)

View trial on ClinicalTrials.gov


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REPLICA: Real Patient Life Treatment With Cabozantinib in Patients With Advanced or Metastatic RCC: A Descriptive and Prospective Non-Interventional Study


Condition: Advanced or Metastatic Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04106349

Sponsor: Ipsen

Phase:

Eligibility:

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

Inclusion Criteria:

  • Males or females aged 18 years and older
  • Patients scheduled to receive Cabometyx® for advanced or metastatic renal cell carcinoma
  • Decision to treat patients with Cabometyx® has to be taken prior to and independent from participation in the clinical study
  • Provision of written informed consent

Exclusion Criteria:

  • Participation in another clinical study at the same time
  • Previous participation in this clinical study

View trial on ClinicalTrials.gov


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A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients With Advanced Renal Cell Carcinoma With Bone Metastasis (RadiCal)


Condition: Advanced Renal Cell Carcinoma, Chromophobe Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Collecting Duct Carcinoma, Kidney Medullary Carcinoma, Metastatic Malignant Neoplasm in the Bone, Papillary Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Unclassified Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04071223

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Documented histologic or cytologic diagnosis of renal cell cancer (RCC). All subtypes of RCC are eligible including but not limited to clear cell, papillary, chromophobe, translocation, collecting duct carcinoma, medullary carcinoma, and unclassified categories. Enrollment of non-clear cell patients will be limited to 20% of the total sample size (~ 42 patients). Once this goal is met, accrual of non-clear cell patients will be discontinued (a notice will be sent out 2 weeks in advance). Sarcomatoid and rhabdoid differentiation are allowed
  • Presence of at least 2 metastatic bone lesions not treated with prior radiation is required
  • The presence of bone metastases can be detected by computed tomography (CT), magnetic resonance imaging (MRI), Tc-99m bone scan or positron emission tomography (PET) (fludeoxyglucose F-18 [FDG] or sodium fluoride [NaF]) imaging. Patients with non-measurable bone-only disease are allowed. Patients may have received prior radiation therapy for bone metastases or other external radiation >= 14 days prior to registration, as long as they still have at least 2 metastatic bone lesions that were not treated with radiation. Patients with visceral metastases are allowed, as long as they have at least two untreated bone metastases
  • No more than 2 prior lines of systemic therapy including but not limited to anti-angiogenic therapy, checkpoint inhibitors, mammalian target of rapamycin (mTOR) inhibitors, clinical trial compounds or cytokine-based therapy. Prior radiation therapy does not count as a prior systemic therapy
  • No prior treatment with cabozantinb
  • No treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitors) within 2 weeks or 5 half-lives (whichever is shorter) of registration or receipt of any anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy) within 3 weeks of registration
  • No prior hemibody external radiotherapy
  • No prior therapy with radium-223 dichloride or systemic radiotherapy (such as samarium, strontium)
  • No major surgery within 6 weeks of randomization. Procedures such as thoracentesis, paracentesis, percutaneous biopsy, Moh's or other topical skin surgery, Lasik eye surgery are not considered major surgery. Patients who have had a nephrectomy may be registered >= 3 weeks after surgery, providing there are no wound-healing complications. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
  • Recovery to baseline or =< grade 1 CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive therapy
  • The use of osteoclast targeted therapy including either bisphosphonates or denosumab is mandated on this study except in patients with contraindications as determined by the treating investigator, including:
  • Hypocalcemia
  • Hypophosphatemia
  • Renal impairment including those with a glomerular filtration rate (GFR) < 35 mL/min using the Cockcroft-Gault equation or acute renal impairment
  • Hypersensitivity to drug formulation
  • Dental condition or need for dental intervention that per the investigator would increase the risk of osteonecrosis of jaw (ONJ).
  • Use of osteoclast targeted therapy or reason against use needs to be recorded in the electronic case report form (eCRF). Additionally, reason for discontinuation of osteoclast targeted therapy need to be appropriately documented in the eCRF
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
  • Therefore, for women of childbearing potential only, a negative urine pregnancy test done =< 28 days prior to registration is required. A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Karnofsky performance status >= 60%
  • Symptomatic bone pain defined as either regular use of analgesic medication for cancer related bone pain (>= level 1; World Health Organization [WHO] ladder for cancer pain) or prior SSE defined as bone pain requiring radiation, bone pain secondary to a pathologic fracture related to a bone metastasis, symptomatic spinal cord compression related to a bone metastasis, surgery to bone secondary to symptomatic bone metastasis or radiographic progression of bone metastases as defined by the presence of bone metastases on radiographic imaging
  • No brain metastases or cranial epidural disease unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator
  • No imminent or established spinal cord compression based on clinical symptoms and/or imaging. In patients with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 2 weeks before registration
  • No imminent or impending pathologic fracture based on clinical symptoms and/or imaging. In patients with untreated imminent or impending pathologic fracture, treatment with standard of care as clinically indicated should be completed at least 2 weeks before registration
  • No significant, uncontrolled intercurrent or recent illness, including but not limited to the following conditions:
  • Cardiovascular disorders: Symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia; uncontrolled hypertension defined as sustained blood pressure > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment; stroke (including transient ischemic attack), myocardial infarction, or other ischemic event, within 6 months before randomization; thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 1 month before randomization; screening Fridericia's correction formula (QTcF) =< 500 msec
  • Gastrointestinal disorders: Disorders associated with a high risk of perforation or fistula formation: active inflammatory bowel disease, active diverticulitis, active cholecystitis, active symptomatic cholangitis or active appendicitis, active acute pancreatitis or active acute obstruction of the pancreatic or biliary duct, or active gastric outlet obstruction; abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 3 months before randomization. Note: Complete healing of an intra-abdominal abscess must be confirmed before randomization
  • No clinically significant hematuria, hematemesis, or hemoptysis, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before randomization
  • No lesions invading major pulmonary blood vessels
  • No other clinically significant disorders:
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy (with no medications prohibited by this protocol [e.g. drug-drug interactions]) with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy (with no medications prohibited by this protocol [e.g. drug-drug interactions]), if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load (with no medications prohibited by this protocol [e.g. drug-drug interactions])
  • No serious non-healing wound or ulcer
  • No malabsorption syndrome
  • No uncompensated/symptomatic hypothyroidism
  • No moderate to severe hepatic impairment (Child-Pugh B or C)
  • No requirements for hemodialysis or peritoneal dialysis
  • No history of solid organ transplantation
  • No chronic concomitant treatment with strong CYP3A4 inducers or inhibitors. Because the list of these agents is constantly changing, it is important to regularly consult a frequently updated medical reference. Patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration
  • No concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants include:
  • Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
  • Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 10 g/dl (transfusions allowed)
  • Calculated (calc.) creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation
  • Total bilirubin =< 1.5 x upper limit of normal (ULN), for patients with Gilberts disease =< 3.0 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
  • Urine protein to creatinine (UPC) ratio =< 1 mg/mg OR 24-hr urine protein < 1g

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A Phase 2, Single-arm Open-label Study of Combination Nivolumab and Ipilimumab Retreatment in Advanced Renal Cell Carcinoma Patients Progressing on Nivolumab Maintenance Therapy After Nivolumab and Ipilimumab Induction


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04088500

Sponsor: Bristol-Myers Squibb

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. -Participants and Target

Disease Characteristics:

  • Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab
  • Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be submitted for embedded tissue block or tumor tissue. Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection. WOCBP need to use contraception throughout the study and for 5 months post treatment.

Exclusion Criteria:

  • autoimmune disease statement
  • Active central nervous system metastases
  • Participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll.
  • Any major surgery 28 days before 1st treatment Concomitant Therapy
  • participants that have received a live vaccine within 30 days of treatment.
  • use of investigational agent or device with in 28 days before first dosage study treatment. Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and Reproduction

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Non - Interventional, Retrospective Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors


Condition: Locally Advanced or Metastatic Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04353765

Sponsor: Ipsen

Phase:

Eligibility:

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

Inclusion Criteria:

  • Evidence of metastatic Renal Cell Carcinoma (mRCC)
  • Receipt of Check Point Inhibitors as the latest treatment for mRCC administrated before index treatment: Tyrosine Kinase Inhibitors
  • Receipt of Tyrosine Kinase Inhibitors
  • Patients who received care at a US Oncology Network site

Exclusion Criteria:

  • Age below 18 years old
  • Patients enrolled in a clinical trial at any time during index treatment
  • Patients receiving treatment for another documented primary cancer diagnoses during the study

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TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) CAPTURE: COVID-19 Antiviral Response in a Pan-tumour Immune Study


Condition: Renal Cell Carcinoma, Cancer, Healthy Volunteers

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03226886

Sponsor: Royal Marsden NHS Foundation Trust

Phase:

Eligibility:

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

Inclusion Criteria:

  • Age 18- years or older
  • Patients with histopathologically confirmed renal cell carcinoma, or suspected renal cell carcinoma, proceeding to neoadjuvant therapy and/or nephrectomy/metastasectomy, or identified as having progressive disease
  • Or in patients undergoing nephrectomy for non-malignant disease
  • Medical and/or surgical management in accordance with national and/or local guidelines
  • Written informed consent Exclusion Criteria:
  • Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would prevent completion of treatment or follow-up
  • Lack of adequate tissue CAPTURE Inclusion criteria
  • Documented informed consent
  • Age 18 years or older
  • Confirmed cancer diagnosis (irrespective of cancer type, disease burden or treatment)
  • Group A: Suspected infection with SARS-CoV-2 or positive test for SARS-CoV-2
  • Group B: no clinical indication to test for SARS-CoV-2 (by current Trust guidelines*) or tested negative for SARS-CoV-2
  • Group C: Volunteers without cancer with SARS-CoV-2 (symptomatic and asymptomatic) and those without clinical indication (current national guidelines*) for SARS-CoV-2 testing or tested negative for SARS-CoV-2

Exclusion Criteria:

  • Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would prevent completion of treatment or follow-up
  • Lack of adequate tissue CAPTURE Inclusion criteria
  • Documented informed consent
  • Age 18 years or older
  • Confirmed cancer diagnosis (irrespective of cancer type, disease burden or treatment)
  • Group A: Suspected infection with SARS-CoV-2 or positive test for SARS-CoV-2
  • Group B: no clinical indication to test for SARS-CoV-2 (by current Trust guidelines*) or tested negative for SARS-CoV-2
  • Group C: Volunteers without cancer with SARS-CoV-2 (symptomatic and asymptomatic) and those without clinical indication (current national guidelines*) for SARS-CoV-2 testing or tested negative for SARS-CoV-2 Exclusion criteria • Medical or psychological condition that would preclude informed consent

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Study of the Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents Compared to Patients Not Treated With Antiangiogenic (Localized Kidney Cancer and Oligometastatic)


Condition: Kidney Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03185039

Sponsor: Institut Paoli-Calmettes

Eligibility:

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

Inclusion Criteria:

  • 1. Patient male or female, aged of more than 18 years 2. Patient with any of the following conditions:
  • Kidney cancer localized at diagnosis.
  • Metastatic kidney cancer when anti-angiogenic therapy is initiated by Sunitinib or Pazopanib
  • Oligometastatic kidney cancer without systemic treatment (local treatment) 3. ECOG = 0 to 2 4. Patient affiliated to, or beneficiary of, the national social security. 5. Patient having signed informed consent

Exclusion Criteria:

  1. Patient previously treated with anti-angiogenic agents.
  2. Person in an emergency situation, adult subject to a legal protection measure (a guardian, guardianship or safeguard of justice), or unable of expressing his / her consent.
  3. Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons
  4. History of malignant disease in the 5 years prior to inclusion (except basal cell carcinoma of the skin or epithelioma of the cervix in situ, or prostate cancer with a good prognosis (stage T <3 and Gleason <7)) accidentally discovered during the histological analysis of the tumor sample. 5- Pregnant or nursing women 6- Contraindications to the procedure of the study

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A Phase II Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03097328

Sponsor: Bradley A. McGregor

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Age ≥ 18 years.
  • Measurable disease according to RECIST 1.1 within 28 days prior to registration.
  • Documented pathologic diagnosis of RCC. All subtypes eligible including but not limited to clear cell, papillary, chromophobe, collecting duct carcinoma, medullary carcinoma, and unclassified categories. Sarcomatoid and rhabdoid differentiation are allowed.
  • Patients with clear cell histology must have demonstrated: 1) Progression on at least one prior anti -angiogenic agent unless intolerable; AND 2) progression on at least one agent that blocks the PD-1 pathway unless felt by the treating physician to be contraindicated (examples include but are not limited to: patients with autoimmune disease or patients requiring systemic steroids greater than 10 mg/day prednisone or its equivalent) or if they have been discontinued due to toxicity. Prior rapalogues are allowed.
  • Patients with non-clear cell histology must have received at least one prior anti-cancer therapy. Prior rapalogues are allowed.
  • Left ventricular ejection fraction (LVEF) ³ lower limit of normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Must have adequate organ and bone marrow function.
  • Hematological
  • Absolute Neutrophil Count (ANC) ≥ 1500 K/mm^3 (without use of G-CSF 4 weeks prior to enrollment)
  • Hemoglobin (Hgb) ≥ 9 g/dL (transfusions allowed)
  • Platelets (Plts) ≥ 100 k/mm^3
  • Renal
  • Calculated creatinine clearance (Cockcroft-Gault formula will be used to calculate creatinine clearance) ≥ 30 mL/min
  • Urinalysis: For patients with 2+ proteinuria on urinalysis, 24 hour urine collection should be obtained, 24 hour urine protein should be <2 grams.
  • Hepatic
  • Bilirubin ≤ 1.5 × upper limit of normal (ULN). For subjects with Gilbert's disease ≤ 3.0 mg/dL
  • Aspartate aminotransferase (AST) ≤ 2.5 × ULN; ≤ 5 x ULN if liver metastases are present
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN; ≤ 5 x ULN if liver metastases are present
  • Metabolic
  • Glycosylated hemoglobin (HbA1c) < 7.0%,
  • Fasting serum glucose ≤ 130 mg/dL
  • Fasting triglycerides ≤ 300 mg/dL
  • Recovery to baseline or ≤ grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 from toxicities related to any prior treatment, unless adverse events are clinically non-significant and/or stable on supportive therapy.
  • Capable of understanding and complying with the protocol requirements and has signed the informed consent document. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Submission of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens from the previous 18 months, if available. If not available, a fresh tumor biopsy prior to treatment initiation is MANDATORY unless determined medically unsafe or not feasible by the site investigator.
  • The archival specimen must contain adequate viable tumor tissue.
  • Specimens may consist of a tissue block (preferred and should contain the highest grade of tumor) or a recommended minimum of 20 unstained serial sections. Fine-needle aspiration, brushings, cell pellet from pleural effusion, bone marrow aspirate/biopsy are not acceptable.
  • Distant metastases specimens are preferred but if not available primary nephrectomy specimens are acceptable.
  • Subjects who experience a disease response per RECIST 1.1 criteria followed by subsequent progression will be required to have a post-treatment biopsy if feasible and safe.
  • Sexually active subjects and their partners must agree to use medically accepted methods of contraception.
  • For women:
  • Postmenopausal for at least 1 year before the screening visit, OR
  • Surgically sterile, OR
  • Agree to practice 1 effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [eg. USPI, SmPC, etc.] after the last dose of study drug, OR
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
  • For men:
  • Even if surgically sterilized (ie, status post-vasectomy), they must agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
  • Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug Exclusion Criteria:
  • Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months of study treatment initiation.
  • Receipt of any type of small molecular 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 3 weeks of enrollment.
  • Treatment with any investigational products within 3 weeks before the first dose of study drug.
  • Radiation therapy for bone metastases within 2 weeks, other external radiation therapy within 4 weeks of enrollment.
  • Received prior hemibody external radiotherapy.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to enrollment as documented by magnetic resonance imaging (MRI) or computed tomography (CT) imaging. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to enrollment as documented by MRI or CT imaging.
  • Imminent or established spinal cord compression based on clinical and/or imaging. In subjects with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 4 weeks before enrollment.
  • The subject has a history of any of the following within the last 6 months before administration of the first dose of the drug:
  • Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures
  • Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures
  • Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)
  • Placement of a pacemaker for control of rhythm
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Significant active cardiovascular or pulmonary disease including:
  • Uncontrolled hypertension defined as sustained BP >160 mm Hg systolic or > 95 mm Hg diastolic despite optimal antihypertensive treatment.
  • Pulmonary hypertension
  • Uncontrolled asthma or O2 saturation < 90% by arterial blood gas analysis or pulse oximetry on room air
  • Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement
  • History of arrhythmia requiring an implantable cardiac defibrillator
  • Medically significant (symptomatic) bradycardia
  • Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/

Exclusion Criteria:

  • Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months of study treatment initiation.
  • Receipt of any type of small molecular 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 3 weeks of enrollment.
  • Treatment with any investigational products within 3 weeks before the first dose of study drug.
  • Radiation therapy for bone metastases within 2 weeks, other external radiation therapy within 4 weeks of enrollment.
  • Received prior hemibody external radiotherapy.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to enrollment as documented by magnetic resonance imaging (MRI) or computed tomography (CT) imaging. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to enrollment as documented by MRI or CT imaging.
  • Imminent or established spinal cord compression based on clinical and/or imaging. In subjects with untreated imminent or established spinal cord compression, treatment with standard of care as clinically indicated should be completed at least 4 weeks before enrollment.
  • The subject has a history of any of the following within the last 6 months before administration of the first dose of the drug:
  • Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures
  • Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures
  • Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)
  • Placement of a pacemaker for control of rhythm
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Significant active cardiovascular or pulmonary disease including:
  • Uncontrolled hypertension defined as sustained BP >160 mm Hg systolic or > 95 mm Hg diastolic despite optimal antihypertensive treatment.
  • Pulmonary hypertension
  • Uncontrolled asthma or O2 saturation < 90% by arterial blood gas analysis or pulse oximetry on room air
  • Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement
  • History of arrhythmia requiring an implantable cardiac defibrillator
  • Medically significant (symptomatic) bradycardia
  • Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are met
  • Active gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation. Subjects with enteric stomata (such as ileostomy, colostomy) are also excluded:
  • Tumors invading the GI-tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction. --Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intraabdominal abscess within 12 weeks before enrollment. NOTE: Complete healing of an intra-abdominal abscess must be confirmed before enrollment.
  • Clinically significant hematemesis or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (such as pulmonary hemorrhage) within 4 weeks of enrollment.
  • Other clinically significant disorders such as:
  • Known active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, chronic hepatitis B or known or suspected active hepatitis C infection.
  • Serious non-healing wound or ulcer.
  • Malabsorption syndrome.
  • Symptomatic hypothyroidism.
  • Moderate to severe hepatic impairment (Child-Pugh B or C).
  • Requirement for hemodialysis or peritoneal dialysis.
  • History of solid organ transplantation.
  • Major surgery (such as GI surgery) within 6 weeks of enrollment. However, subjects who have had a nephrectomy may be enrolled 4 weeks after surgery, providing there are no wound-healing complications. Subjects with clinically relevant ongoing complications from prior surgery are not eligible. The following are not considered to be major procedures: Thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures.
  • QTcF (Fridericia formula for the QT interval correction for the heart rate) > 480 msec within 4 weeks of enrollment. If the initial QTcF is found to be > 480 msec, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤ 480 msec, the subject meets eligibility in this regard. Subjects with history of congenital long QT syndrome, or torsades de pointes, are not allowed.
  • Pregnant or lactating females.
  • Inability to swallow tablets or capsules.
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations.
  • Malignancies other than RCC within 5 years of first study treatment with the exception of those with negligible risk of metastases or death (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).
  • Any serious medical or psychiatric illness that could, in the site investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before receiving the first dose of study drug.

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UroCCR Database: French Research Network for Kidney Cancer (National Multidisciplinary Clinical and Biological Database on Kidney Cancer)


Condition: Kidney Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03293563

Sponsor: University Hospital, Bordeaux

Phase:

Eligibility:

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

Inclusion Criteria:

  • Adult patient with kidney cancer
  • Patient with no opposition to collection of its data for the study

Exclusion Criteria:

  1. none

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A Single-arm Phase II Trial of Intermittent Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy


Condition: Metastatic Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03126331

Sponsor: Case Comprehensive Cancer Center

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Cohort 1:
  • Must have received at least one but not more than two prior anti-angiogenic therapy regimens (including, but not limited to, sunitinib, sorafenib, pazopanib, axitinib, tivozanib, and bevacizumab) in the advanced or metastatic RCC setting. Prior cytokine therapy (eg, IL-2, IFN-a), vaccine therapy, or treatment with cytotoxics is also allowed.
  • No more than three total prior systemic treatment regimens in the advanced or metastatic RCC setting.
  • Cohort 2: --Achieved SD, PR, or CR after administration of front-line therapy with Ipi/Nivo (up to 4 doses) for advanced/metastatic RCC followed by 24 weeks (+/- 8 weeks; minimum 3 infusions) of Nivo maintenance. Patient enrollment will occur after completion of 24 weeks (+/- 8 weeks; minimum 3 infusions) of maintenance nivolumab.
  • Histological confirmation of renal cell carcinoma (RCC) (any histology)
  • Advanced or metastatic RCC.
  • Measurable disease as defined by RECIST 1.1 criteria
  • Must have received at least one but not more than two prior anti-angiogenic therapy regimens (including, but not limited to, sunitinib, sorafenib, pazopanib, axitinib, tivozanib, and bevacizumab) in the advanced or metastatic RCC setting. Prior cytokine therapy (for example, Interleukin (IL)-2, interferon (IFN)-α), vaccine therapy, or treatment with cytotoxics is also allowed.
  • Patients treated with neoadjuvant and/or adjuvant therapy prior to development of metastatic disease may also be included provided that at least 12 months have elapsed since last dose. These regimens do not count toward total number of prior therapies permitted for trial inclusion.
  • No more than three total prior systemic treatment regimens in the advanced or metastatic RCC setting, and must have evidence of progression on or after the last treatment regimen received and within 6 months prior to study enrollment.
  • Karnofsky Performance Score (KPS) ≥70%
  • Women of childbearing potential (WOCBP) must use effective method(s) of contraception have a negative serum or urine pregnancy test within 24 hours prior to the start of therapy, and must not be breastfeeding. Pregnant women are excluded from this study because animal studies have demonstrated that nivolumab can cause fetal harm when administered to pregnant women. Breastfeeding women are excluded from this study because nivolumab may be excreted in human milk and the potential for serious adverse reactions in nursing infants.
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year
  • Willing and able to provide informed consent.
  • Laboratory criteria for study entry must meet the following criteria:
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min (measured or calculated using the Cockcroft-Gault formula).
  • white blood cell count ≥ 2000/µL
  • Neutrophils ≥ 1500/µL
  • Platelets ≥ 100,000/µL
  • Hemaglobin ≥ 9.0g/dL
  • Aspartate Aminotransferase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN
  • Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)

Exclusion Criteria:

  • Cohort 1 only: --Prior treatment with an anti-programmed death (PD)-1, anti-programmed death ligand 1 (PD-L1), anti-programmed death ligand 2 (PD-L2), anti-Cluster of differentiation (CD137), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Anti-cancer therapy less than 14 days prior to the first dose of study drug (less than 28 days for bevacizumab) or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
  • History of severe hypersensitivity reaction to any monoclonal antibody.
  • Patients are excluded if they have active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no imaging evidence of progression for 28 days after treatment is complete and within 28 days prior to the first dose of nivolumab administration.
  • Major surgery (eg, nephrectomy) less than 28 days prior to the first dose of study drug.
  • Any active known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition or prior therapy requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
  • Any known active chronic liver disease.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
  • Known medical condition (for example, a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
  • Strong Cytochrome P450 3A4 (CYP3A4) inhibitors

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Nivolumab in Combination With Ipilimumab in Patients With Metastatic Renal Cell Carcinoma: A Multicenter Single-arm Phase lI Trial


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03297593

Sponsor: Swiss Group for Clinical Cancer Research

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Written informed consent according to Swiss law and ICH/GCP regulations before registration and prior to any trial specific procedures
  • Histologically or cytologically confirmed, locally advanced and/or metastatic clear cell RCC not amenable to surgery or definitive radiotherapy, and requiring systemic therapy
  • Patient able and willing to provide serial biopsies and blood drawings (initial, at 14 weeks (except for patient in the expansion cohort), and at progression).
  • Measurable disease
  • In case of second line patients, the previous therapy must be stopped at least 2 weeks prior to registration
  • Age ≥ 18 years
  • WHO performance status of 0-1
  • Bone marrow function: neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L
  • Hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), AST, ALT and AP ≤ 2.5 x ULN (≤ 5 x ULN if significant hepatic metastasis is suspected to be the cause for enzyme elevation)
  • Renal function: eGFR > 20 mL/min/1.732
  • Cardiac function: NYHA ≤ 2. In case of cardiac insufficiency NYHA 1 or 2, Left ventricular Ejection Fraction (LVEF) ≥ 35% as determined by echocardiography (ECHO) or multigated acquisition (MUGA) scan
  • Women with child-bearing potential are using effective contraception are not pregnant or lactating and agree not to become pregnant during trial treatment and during 5 months thereafter. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential.
  • Men agree not to father a child during trial treatment and during 5 months thereafter

Exclusion Criteria:

  • Uncontrolled CNS metastases. Patients with asymptomatic CNS metastases (at least 2 weeks after radiotherapy or surgery and steroids with prednisone equivalent of 10 mg or lower) are eligible
  • History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of pT1-2 prostate cancer Gleason score < 6, adequately treated cervical carcinoma in situ, or localized non-melanoma skin cancer.
  • More than one previous line of systemic therapy for mRCC
  • Prior immunotherapy.
  • Concurrent or recent (within 30 days of registration) treatment with any other experimental drug
  • Concomitant use of other anti-cancer drugs or radiotherapy except for local pain control (radiotherapy of target lesion not allowed)
  • Immunosuppressive medications (such as but not limited to: methotrexate, azathioprine, and TNF-α blockers) within 30 days before registration Exception:
  • systemic corticosteroids at doses not exceeding 10 mg/day of prednisone or equivalent
  • immunosuppressive medications for patients with contrast allergies
  • inhaled and intranasal corticosteroids
  • Live attenuated vaccination within 30 days prior to registration and for 30 days after last dose of any of the trial drugs. Inactivated viruses, such as those in the influenza vaccine, are permitted
  • History of or active auto-immune disease with the exception of diabetes mellitus type II
  • Human immunodeficiency virus (HIV) infection or active chronic Hepatitis C or Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment
  • Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

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Diagnostic Value of Multiparametric MR Imaging of Small Solid Renal Tumors (IRMK01)


Condition: Renal Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03470285

Sponsor: University Hospital, Bordeaux

Eligibility:

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

Inclusion Criteria:

  • Age ≥ 18;
  • Performance Index ≤ 2 (WHO);
  • Non hereditary solid renal tumors;
  • Indication of renal surgery or renal biopsy for suspicion of malignancy of the tumor
  • Size of renal mass between 1,5 and 4 cm;
  • Single Renal mass;
  • Discovered incidentally by US and / or CT-scan;
  • IRMK01 and UroCCR Informed consents signed.
  • Affiliated or beneficiary of French social security
  • All women of childbearing potential must have effective contraception from the time of screening until MRI. Acceptable methods of contraception include combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable) intrauterine device, intrauterine hormonereleasing system, bilateral tubal occlusion, vasectomized partner and sexual abstinence

Exclusion Criteria:

  • Patent signs of malignancy (metastasis, lymphadenopathy, thrombus ...);
  • Cystic lesions according to the Bosniak classification;
  • Lesions with macroscopic fat on ultrasound or CT-scan;
  • Multiple or bilateral renal tumors;
  • Histological evidence available initially;
  • History of renal neoplasia whatever the location or family context (Von Hippel Lindau, Bourneville sclerosis);
  • Moderate to terminal renal impairment documented (creatinine clearance <30 mL / min according MDRD or CKD-EPI);
  • Impossibility to perform MRI :
  • heart pacemakers (especially older types)
  • insulin pumps
  • implanted hearing aidsIRMK01 Version no.3.0 of 28/10/2020 Page 12 of 83
  • neurostimulators
  • intracranial metal clips
  • metallic bodies in the eye
  • Contraindication to gadolinium salt.
  • Patient's refusal of surgery, biopsy if necessary;
  • Minor
  • Person deprived of liberty
  • Person under trusteeship
  • Person under curatorship
  • Person under legal guardianship
  • Pregnant or nursing women.
  • Adults unable to express their consent
  • Females of child-bearing potential without a negative pregnancy test prior to MRI exam
  • Clinical follow-up not possible for psychological, family, social or geographic reasons.

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A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses


Condition: Clear Cell Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03849118

Sponsor: Telix International Pty Ltd

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  1. Written and voluntarily given Informed Consent
  2. Male or female ≥18 years of age
  3. Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC
  4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
  5. Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
  6. for patients included in France only, verification and confirmation of their affiliation with a social security
  7. Sufficient life expectancy to justify nephrectomy
  8. Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration

Exclusion Criteria:

  1. Bioptic procedure (rather than a partial or total nephrectomy) planned for histological species delineation of IRM
  2. Renal mass known to be a metastasis of another primary tumour
  3. Active non-renal malignancy requiring therapy during the time frame of the study participation
  4. Chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
  5. Planned antineoplastic therapies (for the period between administration of 89 Zr-TLX250 and imaging)
  6. Exposure to murine or chimeric antibodies within the last 5 years
  7. Previous administration of any radionuclide within 10 half-lives of the same
  8. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator
  9. Mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study
  10. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX250
  11. Women who are pregnant or breastfeeding
  12. Known hypersensitivity to Girentuximab or DFO (Desferrioxamine)
  13. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2
  14. Vulnerable patients (e.g being in detention)

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A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)


Condition: Advanced Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02996110

Sponsor: Bristol-Myers Squibb

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Advanced Renal Cell Carcinoma
  • Must have at least 1 lesion with measurable disease
  • Life expectancy of at least 3 months
  • Karnofsky Performance Status (KPS) must be =>70% Exclusion Criteria:
  • Patients/subjects with suspected or known central nervous system metastases unless adequately treated
  • Patients/subjects with autoimmune disease
  • Patients/subjects who need daily oxygen therapy Other protocol defined inclusion/

Exclusion Criteria:

  • Patients/subjects with suspected or known central nervous system metastases unless adequately treated
  • Patients/subjects with autoimmune disease
  • Patients/subjects who need daily oxygen therapy Other protocol defined inclusion/exclusion criteria could apply

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Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer


Condition: Metastatic Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04090710

Sponsor: Ontario Clinical Oncology Group (OCOG)

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Biopsy proven renal cell carcinoma of any histology.
  2. Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening.
  3. Intermediate/poor risk disease based on IMDC criteria (see Appendix II).
  4. Primary kidney lesion amenable to SBRT.
  5. Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph.

Exclusion Criteria:

  1. A maximum primary renal lesion size of 20 cm or greater.
  2. Candidate for cytoreductive nephrectomy, unless a patient has refused cytoreductive nephrectomy (in this case, a discussion of cytoreductive nephrectomy and patient refusal must be documented).
  3. Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma.
  4. Previous abdominal radiation precluding SBRT.
  5. Kanofsky Performance (KPS) score below 60 (see Appendix III).
  6. History of auto-immune disorder precluding treatment with ipilimumab or nivolumab.
  7. History of ataxia telangiectasia or other radiation sensitivity disorders.
  8. Chronic corticosteroid use or other chronic immune suppressive therapy. (Participants are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses of prednisone ≤ 10 mg daily are permitted).
  9. Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician.
  10. Inability to lie flat for at least 30 minutes without moving.
  11. Pregnant or lactating women.
  12. Geographic inaccessibility for follow-up.
  13. Inability to provide informed consent.

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Clinical Research Platform On Renal Cell Carcinoma Treatment And Outcome (Registry Platform Renal Cell Carcinoma; CARAT)


Condition: Renal Cell Carcinoma

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT03374267

Sponsor: iOMEDICO AG

Phase:

Eligibility:

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

Inclusion Criteria:

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

Exclusion Criteria:

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

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