Phase
Condition
Renal Cancer
Urologic Cancer
Carcinoma
Treatment
Cabozantinib
Belzutifan
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has locally advanced or metastatic RCC with predominantly clear cell subtype
Has at least one measurable lesion as defined by RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Has adequate organ function defined as follows:
Absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL and plateletcount ≥ 100,000/µL without transfusion or growth factor support within 2 weeksprior to obtaining the hematology values at screening;
Serum creatinine level ≤ 2.0 × upper limit of normal (ULN)
Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); totalbilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease *Cohort 1:Participants must not have received prior systemic therapy for advanced ormetastatic ccRCC
Cohort 2: Participants must have received prior immunotherapy and no more than twoprior treatments for advanced or metastatic ccRCC
Exclusion
Exclusion Criteria:
Has received prior treatment with belzutifan or other HIF2α inhibitors
Has received prior treatment with cabozantinib
Has had radiation therapy for bone metastases within two weeks of starting studydrug
Has a history of untreated brain metastases or history of leptomeningeal disease orspinal cord compression
Has failed to recover from the reversible effects of prior anticancer therapy
Has uncontrolled or poorly controlled hypertension
Is receiving anticoagulant therapy
Has had any major cardiovascular event within 6 months prior to study drugadministration
Has any other clinically significant cardiac, respiratory, or other medical orpsychiatric condition that might interfere with participation in the trial orinterfere with the interpretation of trial results
Has had major surgery within 3 months before first study drug administration
Has an active infection requiring systemic treatment
Is participating in another therapeutic clinical trial
Study Design
Connect with a study center
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0003)
Los Angeles, California 90048
United StatesSite Not Available
USC Norris Comprehensive Cancer Center ( Site 0060)
Los Angeles, California 90033
United StatesSite Not Available
Sylvester Comprehensive Cancer Center ( Site 0023)
Miami, Florida 33136
United StatesSite Not Available
Dana Farber Cancer Center ( Site 0006)
Boston, Massachusetts 02215
United StatesSite Not Available
Karmanos Cancer Institute ( Site 0033)
Detroit, Michigan 48201
United StatesSite Not Available
Tennessee Oncology, PLLC ( Site 0024)
Chattanooga, Tennessee 37404
United StatesSite Not Available
Tennessee Oncology, PLLC ( Site 0001)
Nashville, Tennessee 37203
United StatesSite Not Available
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0010)
Dallas, Texas 75246
United StatesSite Not Available
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035)
Seattle, Washington 98109
United StatesSite Not Available
Swedish Cancer Institute ( Site 0018)
Seattle, Washington 98104
United StatesSite Not Available

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