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Clinical Trials in the USA / NCT03634540
Active, not recruiting Phase 2

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

NCT03634540 · tracked via the Priya Life Science USA tracker
Sponsor
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase
Phase 2
Started
2018-09-27
Last updated
2024-12-20

Condition(s) studied

Renal Cell Carcinoma (RCC)Clear Cell Renal Cell Carcinoma (ccRCC)Kidney CancerRenal CancerRenal Cell CarcinomaRenal Cell Cancer MetastaticRenal Cell Carcinoma RecurrentRenal Cell Cancer, RecurrentKidney

Investigational drug(s) / intervention(s)

BelzutifanCabozantinib

Belzutifan: Belzutifan tablets administered orally.

Cabozantinib: Cabozantinib tablets administered orally.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
USC Norris Comprehensive Cancer Center ( Site 0060) Los Angeles California
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0003) Los Angeles California
Sylvester Comprehensive Cancer Center ( Site 0023) Miami Florida
Dana Farber Cancer Center ( Site 0006) Boston Massachusetts
Karmanos Cancer Institute ( Site 0033) Detroit Michigan
Tennessee Oncology, PLLC ( Site 0024) Chattanooga Tennessee
Tennessee Oncology, PLLC ( Site 0001) Nashville Tennessee
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0010) Dallas Texas
Swedish Cancer Institute ( Site 0018) Seattle Washington
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035) Seattle Washington
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03634540 on ClinicalTrials.gov ↗ ← All trials in the USA