A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
Running, not enrolling · Phase 2
Conditions studied: Renal Cell Carcinoma (RCC), Clear Cell Renal Cell Carcinoma (ccRCC), Kidney Cancer, Renal Cancer, Renal Cell Carcinoma, Renal Cell Cancer Metastatic, Renal Cell Carcinoma Recurrent, Renal Cell Cancer, Recurrent, Kidney
In brief
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.
Key facts
- Study ID
- NCT03634540
- Run by
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 118
- Starts
- 2018-09-27
- Expected to finish
- 2027-02-26
- Last updated by the study team
- 2024-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- USC Norris Comprehensive Cancer Center ( Site 0060) — Los Angeles, California, United States
- Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0003) — Los Angeles, California, United States
- Sylvester Comprehensive Cancer Center ( Site 0023) — Miami, Florida, United States
- Dana Farber Cancer Center ( Site 0006) — Boston, Massachusetts, United States
- Karmanos Cancer Institute ( Site 0033) — Detroit, Michigan, United States
- Tennessee Oncology, PLLC ( Site 0024) — Chattanooga, Tennessee, United States
- Tennessee Oncology, PLLC ( Site 0001) — Nashville, Tennessee, United States
- Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0010) — Dallas, Texas, United States
- Swedish Cancer Institute ( Site 0018) — Seattle, Washington, United States
- Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035) — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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