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

Phase 2Active Not RecruitingNCT03634540

Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)118 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

118

Conditions

Renal Cell Carcinoma (RCC)Clear Cell Renal Cell Carcinoma (ccRCC)Kidney Cancer Renal Cancer Renal Cell Carcinoma Renal Cell Cancer Metastatic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

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

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

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).