A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)

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