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NCT03634540 · ClinicalTrials.gov registry record · 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)

A Phase 2 study of Renal Cell Carcinoma and Kidney Cancer, sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Active
Registry status
Phase 2
Development phase
118
Enrollment target
10
Study locations

NCT03634540: Active Phase 2 study of Renal Cell Carcinoma and Kidney Cancer, sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

NCT03634540 is a Phase 2 study of Renal Cell Carcinoma and Kidney Cancer that is active but no longer recruiting, run by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 118 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (51% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03634540, a Phase 2 study of Renal Cell Carcinoma and Kidney Cancer, is active but no longer recruiting, sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
118 participants
Enrollment target
10
Study locations

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.

Primary Outcome

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).

Conditions Studied

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

Interventions

  • DRUG Belzutifan
  • DRUG Cabozantinib

Study Locations (10)

California

  • USC Norris Comprehensive Cancer Center ( Site 0060) - Los Angeles
  • Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0003) - Los Angeles

Tennessee

  • Tennessee Oncology, PLLC ( Site 0024) - Chattanooga
  • Tennessee Oncology, PLLC ( Site 0001) - Nashville

Washington

  • Swedish Cancer Institute ( Site 0018) - Seattle
  • Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035) - Seattle

Florida

  • Sylvester Comprehensive Cancer Center ( Site 0023) - Miami

Massachusetts

  • Dana Farber Cancer Center ( Site 0006) - Boston

Michigan

  • Karmanos Cancer Institute ( Site 0033) - Detroit

Texas

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0010) - Dallas

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2018-09-27
Est. Completion 2027-02-26
Phase Phase 2
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

6 total trials

What the registry record for NCT03634540 still lists

NCT03634540 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (51% lower).

The record links to 9 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Belzutifan is the first listed.

NCT03634540 lists 10 locations in 7 states (California, Tennessee, Washington).

Frequently Asked Questions

What is clinical trial NCT03634540 about?

NCT03634540 is a clinical study titled "A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)". 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.

What is the current status of trial NCT03634540?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2018-09-27. Estimated completion is 2027-02-26.

What conditions does trial NCT03634540 study?

This clinical trial studies the following conditions: Renal Cell Carcinoma, Kidney Cancer, Renal Cancer, Renal Cell Carcinoma (RCC), Clear Cell Renal Cell Carcinoma (ccRCC).

What interventions are being tested in trial NCT03634540?

The interventions under investigation include: Belzutifan (DRUG), Cabozantinib (DRUG).

Who is sponsoring clinical trial NCT03634540?

This trial is sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03634540 being conducted?

This trial has 10 study locations across California, Florida, Massachusetts, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Renal Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03634540's enrollment target sits among peer trials

118 48th of 121 higher than 74 of 121 other Renal Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03634540, the US trial registry maintained by the National Library of Medicine. NCT03634540 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.