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NCT05239728 · ClinicalTrials.gov registry record · Phase 3

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

A Phase 3 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 3
Development phase
1,800
Enrollment target
20
Study locations

NCT05239728: Active Phase 3 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.

NCT05239728 is a Phase 3 study of Carcinoma, Renal Cell that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 1,800 participants, above the 230-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (683% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05239728, a Phase 3 study of Carcinoma, Renal Cell, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,800 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).

Primary Outcome

DFS is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es) as assessed by investigator, or death due to any cause, whichever occurs first. The DFS for all participants will be presented.

Conditions Studied

Carcinoma, Renal Cell

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Placebo
  • DRUG Belzutifan

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center ( Site 3567) - Duarte
  • Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516) - La Jolla
  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 3520) - Los Angeles
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518) - Orange
  • Stanford Cancer Center ( Site 3523) - Palo Alto

Massachusetts

  • Massachusetts General Hospital ( Site 3571) - Boston
  • Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572) - Boston
  • Dana-Farber Cancer Institute-GU ( Site 3505) - Boston

Colorado

  • University of Colorado Anschutz Medical Campus ( Site 3514) - Aurora
  • Intermountain Health St. Mary's Regional Hospital ( Site 3562) - Grand Junction

Florida

  • University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 3517) - Miami
  • Moffitt Cancer Center ( Site 3540) - Tampa

Arizona

  • Mayo Clinic in Arizona - Phoenix ( Site 3554) - Phoenix

District of Columbia

  • Georgetown University Medical Center ( Site 3534) - Washington D.C.

Georgia

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515) - Marietta

Indiana

  • Parkview Research Center at Parkview Regional Medical Center ( Site 3526) - Fort Wayne

Trial Details

FieldValue
Enrollment Target 1,800 participants
Start Date 2022-03-15
Est. Completion 2029-09-28
Phase Phase 3
Merck Sharp & Dohme

558 total trials

What the registry record for NCT05239728 still lists

NCT05239728 is an interventional study that assigns participants to a tested intervention. Its 1,800 participants enrollment target places it among the larger protocols in the corpus, above the 230-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (683% higher).

The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT05239728 names 20 study sites across 12 states, led by California, Massachusetts, Colorado.

Frequently Asked Questions

What is clinical trial NCT05239728 about?

NCT05239728 is a clinical study titled "A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)". The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is th...

What is the current status of trial NCT05239728?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,800 participants. The study started on 2022-03-15. Estimated completion is 2029-09-28.

What conditions does trial NCT05239728 study?

This clinical trial studies the following conditions: Carcinoma, Renal Cell.

What interventions are being tested in trial NCT05239728?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Belzutifan (DRUG).

Who is sponsoring clinical trial NCT05239728?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05239728 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. 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 NCT05239728's enrollment target sits among peer trials

1,800 1st of 34 higher than 34 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.

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

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Related registry views

Source: ClinicalTrials.gov NCT05239728, the US trial registry maintained by the National Library of Medicine. NCT05239728 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.