Kidney/Renal Cancer

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A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03873402

Sponsor: Bristol-Myers Squibb

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
  • Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
  • Measurable disease by CT or MRI per RECIST 1.1 criteria.
  • No prior systemic therapy for RCC
  • Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC). Exclusion Criteria:
  • Any active central nervous system (CNS) metastases.
  • Active, known, or suspected autoimmune disease.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol defined inclusion/

Exclusion Criteria:

  • Any active central nervous system (CNS) metastases.
  • Active, known, or suspected autoimmune disease.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol defined inclusion/exclusion criteria could apply

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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, Advanced Retinal Disease Carcinoma, Renal Medullary 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.

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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)

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A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03937219

Sponsor: Exelixis

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.
  • Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria.
  • Measurable disease per RECIST 1.1 as determined by the Investigator.
  • Karnofsky Performance Status (KPS) ≥ 70%.
  • Adequate organ and marrow function.

Exclusion Criteria:

  • Prior systemic anticancer therapy for unresectable locally advanced or metastatic RCC including investigational agents.
  • Uncontrolled, significant intercurrent or recent illness including, but not limited to serious cardiovascular disorders (including uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment), GI disorders associated with high risk for perforation or fistula formation, tumors invading GI tract, bowel obstruction, intra-abdominal abscess, clinically significant bleeding events, cavitating pulmonary lesions, or lesions invading major pulmonary blood vessels.
  • Other clinically significant disorders such as: i. Autoimmune disease that has been symptomatic or required treatment within the past two years from the date of randomization. ii. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. iii. Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active myobacterial infection.
  • Major surgery (eg, nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. Minor surgeries within 10 days prior to randomization. Subjects must have complete wound healing from major or minor surgery before randomization.
  • Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.

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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

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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))


Condition: Renal Cell Carcinoma

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

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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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Assessment of Quality of Life and Outcomes in Patients Treated With Stereotactic Body Radiation Therapy (SBRT) for Primary Renal Cell Carcinoma (RCC) - AQuOS-RCC


Condition: Renal Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03108703

Sponsor: Sunnybrook Health Sciences Centre

Eligibility:

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

Inclusion Criteria:

  • Patients ≥18 years old
  • Medically inoperable or patient who refuses surgery
  • Histologic diagnosis of RCC where possible, or radiologic evidence of growth on surveillance
  • Lesion ≥2.5cm or recurrent lesion following local ablative therapy
  • Written informed consent
  • Participants must be able to understand the English-language or with the aid of a translator

Exclusion Criteria:

  • ECOG ≥3
  • Prior abdominal radiation

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Provider Referral Patterns Following Nephrectomy in High-Risk Locoregional Renal Cell Carcinoma


Condition: Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04309617

Sponsor: Pfizer

Phase:

Eligibility:

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

Inclusion Criteria:

  • Patients must meet all of the following inclusion criteria to be eligible for data abstraction:
  • Diagnosed with locoregional RCC (no distant metastasis at the time of diagnosis)
  • Underwent a nephrectomy at Duke between 01 April 2014, and 31 December 2019 (final dates determined based on results from part 2 data collection)
  • Aged 18 years or older at nephrectomy

Exclusion Criteria:

  • none

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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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TFE Renal Cell Carcinoma: A Prospective Registry and Translational Research Initiative


Condition: Renal Cell Carcinoma

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT03630536

Sponsor: Children's Hospital Medical Center, Cincinnati

Phase:

Eligibility:

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

Inclusion Criteria:

  • All patients of any age with a suspected diagnosis or confirmed diagnosis of a TFE Renal Cell Carcinoma.
  • Unless the patient is deceased, all patients and/or one parent or legal guardian must provide written informed consent as well as HIPAA/release of information consent.

Exclusion Criteria:

  • Any patient that has not been diagnosed with TFE Renal Cell Carcinoma

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Prospective, Post Marketing Surveillance to Observe Safety and Effectiveness of CABOMETYX™ Under the Real Practice Setting in Patients With Renal Cell Carcinoma in Korea.


Condition: Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03776123

Sponsor: Ipsen

Phase:

Eligibility:

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

Inclusion Criteria:

  • Patients who meet 'Indications' of Cabometyx™ label
  • Patients who are treated with Cabometyx™ for the first time according to Cabometyx™ label
  • Patients who are aged 18 years or older
  • Patients who are willing to provide written consent after being informed of this surveillance

Exclusion Criteria:

  • Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label

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BrUOG 354: A Phase II Randomized Trial of Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas


Condition: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Extra Renal Origin, Clear Cell Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03355976

Sponsor: Don Dizon

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patients must have a recurrent, advanced, or metastatic pure clear cell carcinoma of ovarian, fallopian tube, primary peritoneal, or extra-renal origin.
  • All patients must submit representative tissue from their malignancy.
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
  • Patients with a clear cell carcinoma of ovarian, fallopian or primary peritoneal origin must have progressed after at least one prior platinum and taxane based chemotherapy regimen. Patients with extra-renal clear cell cancer (including other GYN) cancers must have progressed after at least one prior regimen for advanced/metastatic disease. Radiation therapy (including the use of chemotherapy as a radiosensitizer) will not count as a prior systemic regimen.
  • No prior anti-PD-1, PD-L1 or CTLA-4 antibody.
  • Age ≥ 18
  • ECOG performance status 0 to 1
  • Participants must have normal organ and marrow function as defined below: leukocytes ≥3,000/mcL absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin within normal institutional limits EXCEPTIONS: conjugated hyperbilirubinemia; Gilbert's syndrome, both of which will allow a total bilirubin <3.0mg/dL <5xULN is liver metastases are present A value below the LLN is acceptable if confirmed appropriate by the treating MD AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal creatinine ≤ 1.5 X ULN (upper limit of normal) OR creatinine clearance ≥50 mL/min
  • Adequate thyroid function within 28 days prior to registration defined as serum TSH in normal range. Patients on thyroid hormone supplementation are allowed provided the serum TSH is within normal limits.
  • Subjects must have a resting baseline O2 saturation by pulse oximetry of ≥92% at rest. This should be documented within two weeks of registration.
  • Reproductive status:
  • Women of childbearing potential (WOCBP) must use method(s) of contraception. Given there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required as determined by the treating investigator. WOCBP must follow instructions for birth control. For all women who discontinue protocol treatment, contraception should be continued for five months following the last dose of therapy.
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to the start of registration.
  • Women who are not of childbearing potential (ie, who are postmenopausal (lack of menses > 24 months) or surgically sterile) and azospermic men do not require contraception.
  • Women must not be breastfeeding (document for all).
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1 % per year. The investigator shall review contraception methods and the time period that contraception must be followed.
  • Men that are sexually active with WOCBP must follow instructions for birth control when the half life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 7 months after discontinuation of treatment.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who have had prior therapy with nivolumab or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways.
  • Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients using endocrine therapy as treatment for their index cancer must be off of treatment for one week (7 days) prior to entering the study.
  • Participants who have not recovered from clinically significant adverse events to
  • Participants who are receiving any other investigational agents.
  • Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of severe hypersensitivity reaction to any monoclonal antibody.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the last three years. However, patients with a malignancy that is not-likely to require treatment in the next 2 years, such as a completely resected, early stage breast cancer, are eligible.
  • Patients who have received prior chemotherapy within the last three years for any other cancer other than for clear cell cancer.
  • In order for patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) to be eligible, they must be on a stable highly active antiretroviral therapy (HAART) regimen, have CD4 counts > 350, with no detectable viral load on quantitative PCR within 4 weeks of registration.
  • Patients with treated hepatitis virus infections (Hepatitis B or Hepatitis C) are eligible if they have been definitively treated for 6 months, have no detectable viral load on quantitative PCR, and LFTs meet eligibility requirements within 4 weeks of screening.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded.
  • Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of day 1 study drug administration.
  • Any other medical condition that will prevent the safe administration of study drugs in the opinion of the treating physician.
  • Planned concomitant, non-protocol directed anti-cancer therapy during the trial.
  • Grade ≥2 peripheral neuropathy

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Blood Drawing for Study of Peripheral Blood T-lymphocytes and Other Parameters in Patients With Metastatic Melanoma and Renal Cell Cancer With Spontaneous Regression


Condition: Melanoma; Renal Cell Carcinoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03728842

Sponsor: Indiana University

Phase:

Eligibility:

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

Inclusion Criteria:

  1. ≥ 18 years old at the time of informed consent
  2. Ability to provide written informed consent and HIPAA authorization
  3. Patients must have metastatic melanoma or renal cell cancer with spontaneous regression.
  4. Willingness to undergo phlebotomy for research blood samples

Exclusion Criteria:

  1. Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety
  2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

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A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With Metastatic Renal Cell Carcinoma in Latin America


Condition: Metastatic Renal Cell Carcinoma ( mRCC)

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04115189

Sponsor: Pfizer

Phase:

Eligibility:

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

Inclusion Criteria:

  1. Diagnosed with metastatic RCC with clear cell histology a. The patient may have been initially diagnosed with Stage IV or initially diagnosed at an earlier stage and progressed to having disease at distant sites (i.e., metastatic disease)
  2. Initiated first-line treatment for metastatic RCC with sunitinib on the 4/2 schedule (all countries) or initiated first-line treatment for metastatic RCC with sunitinib on the 2/1 schedule (Brazil only)
  3. Switched to the 2/1 schedule (all countries) or initiated the 2/1 schedule (Brazil only) during the first treatment line between January 1, 2014, and June 30, 2018 a. The final dates defining this selection period will be dependent on country-specific ethics and reporting requirements

Exclusion Criteria:

  1. Evidence of other malignant neoplasms (except nonmelanoma skin cancer or carcinoma in situ) within 5 years before switching to the sunitinib 2/1 schedule (all countries) or initiation of the 2/1 schedule (Brazil only)

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