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NCT03401788 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004)
A Phase 2 study of VHL-Associated Clear Cell Renal Cell Carcinoma and VHL-Associated Renal Cell Carcinoma, sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 11
- Study locations
NCT03401788: Active Phase 2 study of VHL-Associated Clear Cell Renal Cell Carcinoma and VHL-Associated Renal Cell Carcinoma, sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT03401788 is a Phase 2 study of VHL-Associated Clear Cell Renal Cell Carcinoma and VHL-Associated Renal Cell Carcinoma 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 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03401788, a Phase 2 study of VHL-Associated Clear Cell Renal Cell Carcinoma and VHL-Associated Renal Cell Carcinoma, 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
- 50 participants
- Enrollment target
- 11
- Study locations
Study Summary
This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.
Primary Outcome
ORR is defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be assessed by independent review committee (ICR) for the primary analysis.
Conditions Studied
Interventions
- DRUG Belzutifan
Study Locations (11)
Other
- Aarhus University Hospital - Aarhus
- Hospital Georges Pompidou - Paris
- Cambridge University Hospital - Cambridge
Pennsylvania
- University of Pennsylvania Medical Center - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Maryland
- National Institutes of Health Clinical Center - Bethesda
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- University of Michigan - Ann Arbor
Tennessee
- Vanderbilt Medical Center - Nashville
Texas
- MD Anderson Cancer Center - Houston
Utah
- Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-05-02 |
| Est. Completion | 2026-03-29 |
| Phase | Phase 2 |
Sponsor
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)6 total trials
What the registry record for NCT03401788 still lists
NCT03401788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 6 conditions, with VHL-Associated Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Belzutifan is the first listed.
NCT03401788 lists 11 locations in 8 states (Other, Pennsylvania, Maryland).
Frequently Asked Questions
What is clinical trial NCT03401788 about?
NCT03401788 is a clinical study titled "A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004)". This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.
What is the current status of trial NCT03401788?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2018-05-02. Estimated completion is 2026-03-29.
What conditions does trial NCT03401788 study?
This clinical trial studies the following conditions: VHL-Associated Clear Cell Renal Cell Carcinoma, VHL-Associated Renal Cell Carcinoma, VHL - Von Hippel-Lindau Syndrome, VHL Gene Mutation, VHL Syndrome.
What interventions are being tested in trial NCT03401788?
The interventions under investigation include: Belzutifan (DRUG).
Who is sponsoring clinical trial NCT03401788?
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 NCT03401788 being conducted?
This trial has 11 study locations across Maryland, Massachusetts, Michigan, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for VHL-Associated Clear Cell 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 NCT03401788's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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