Overview

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

Status:
Recruiting
Trial end date:
2025-08-31
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peloton Therapeutics, Inc.
Criteria
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