Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Prostate, Bladder, and Kidney Cancers
Enrollment Eligibility
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