Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,800 participants |
| Start Date | 2022-03-15 |
| Est. Completion | 2029-09-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05239728
The ClinicalTrials.gov registry entry for NCT05239728 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 230-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (683% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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
Similar trials for Carcinoma, Renal Cell
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.
-
Savolitinib vs. Sunitinib in MET-driven PRCC.
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)
ACTIVE NOT RECRUITING · Phase 3
-
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
COMPLETED · Phase 3
-
Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination with Sunitinib in Patients with TKIs-resistant RCC
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.