This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 platelet count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening;
* Serum creatinine level ≤ 2.0 × upper limit of normal (ULN)
* Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease \*Cohort 1: Participants must not have received prior systemic therapy for advanced or metastatic ccRCC
* Cohort 2: Participants must have received prior immunotherapy and no more than two prior treatments for advanced or metastatic ccRCC
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 study drug
* Has a history of untreated brain metastases or history of leptomeningeal disease or spinal cord compression
* Has failed to recover from the reversible effects of prior anticancer therapy
* Has uncontrolled or poorly controlled hypertension
* Is receiving anticoagulant therapy
* Has had any major cardiovascular event within 6 months prior to study drug administration
* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
* Has had major surgery within 3 months before first study drug administration
* Has an active infection requiring systemic treatment
* Is participating in another therapeutic clinical trial
Primary outcome measure(s)
Overall Response Rate (ORR) — Up to approximately 2 years ORR is defined as the percentage of participants with a best confirmed response of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Trial sites (10)
Facility
City
Region
Status
USC Norris Comprehensive Cancer Center ( Site 0060)
Los Angeles
California
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0003)
Los Angeles
California
Sylvester Comprehensive Cancer Center ( Site 0023)
Miami
Florida
Dana Farber Cancer Center ( Site 0006)
Boston
Massachusetts
Karmanos Cancer Institute ( Site 0033)
Detroit
Michigan
Tennessee Oncology, PLLC ( Site 0024)
Chattanooga
Tennessee
Tennessee Oncology, PLLC ( Site 0001)
Nashville
Tennessee
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0010)
Dallas
Texas
Swedish Cancer Institute ( Site 0018)
Seattle
Washington
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035)
Seattle
Washington
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.