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NCT04489771 · ClinicalTrials.gov registry record · Phase 2
A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)
A Phase 2 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 20
- Study locations
NCT04489771: Active Phase 2 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.
NCT04489771 is a Phase 2 study of Carcinoma, Renal Cell that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 154 participants, below the 279-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04489771, a Phase 2 study of Carcinoma, Renal Cell, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR).
Primary Outcome
ORR was defined as the percentage of participants who had a 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 RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented.
Conditions Studied
Interventions
- DRUG Belzutifan
Study Locations (20)
Nebraska
- Cancer Partners of Nebraska ( Site 0003) - Lincoln
- Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0012) - Omaha
New York
- New York Oncology Hematology P.C ( Site 0028) - Albany
- Roswell Park Cancer Institute ( Site 0038) - Buffalo
Tennessee
- UT West Cancer Center ( Site 0032) - Germantown
- Urology Associates ( Site 0015) - Nashville
Texas
- University of Texas Southwestern Medical Center at Dallas ( Site 0004) - Dallas
- Baylor Scott & White Medical Center - Temple ( Site 0013) - Temple
Virginia
- Inova Schar Cancer Institute ( Site 0001) - Fairfax
- Blue Ridge Cancer Care - Roanoke ( Site 0017) - Roanoke
District of Columbia
- Georgetown University Medical Center ( Site 0002) - Washington D.C.
Florida
- Univ of Miami- Sylvester Comprehensive Cancer Center ( Site 0023) - Miami
Kentucky
- Norton Cancer Institute - St. Matthews ( Site 0025) - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2020-09-13 |
| Est. Completion | 2026-10-04 |
| Phase | Phase 2 |
What the registry record for NCT04489771 still lists
NCT04489771 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 279-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 1 intervention - of which Belzutifan is the first listed.
NCT04489771 names 20 study sites across 15 states, led by Nebraska, New York, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04489771 about?
NCT04489771 is a clinical study titled "A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)". This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective resp...
What is the current status of trial NCT04489771?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2020-09-13. Estimated completion is 2026-10-04.
What conditions does trial NCT04489771 study?
This clinical trial studies the following conditions: Carcinoma, Renal Cell.
What interventions are being tested in trial NCT04489771?
The interventions under investigation include: Belzutifan (DRUG).
Who is sponsoring clinical trial NCT04489771?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04489771 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Kentucky, Maryland, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04489771's enrollment target sits among peer trials
154 14th of 34 higher than 21 of 34 other Carcinoma, Renal Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Renal Cell 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.
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