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NCT04736706 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 1,653
- Enrollment target
- 20
- Study locations
NCT04736706: Active Phase 3 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.
NCT04736706 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 1,653 participants, above the 235-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (603% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04736706, 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
- 1,653 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
Primary Outcome
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR based on RECIST 1.1 will be presented.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Belzutifan
- DRUG Lenvatinib
- BIOLOGICAL Pembrolizumab/Quavonlimab
Study Locations (20)
California
- UC San Diego ( Site 0050) - La Jolla
- Cedars Sinai Medical Center ( Site 0027) - Los Angeles
- University of California Irvine ( Site 0029) - Orange
- UCLA Hematology Oncology Santa Monica ( Site 0048) - Santa Monica
Massachusetts
- Massachusetts General Hospital ( Site 0094) - Boston
- Beth Israel Deaconess Medical Center ( Site 0089) - Boston
- Dana Farber Cancer Institute ( Site 0093) - Boston
- Lahey Hospital & Medical Center ( Site 0090) - Burlington
Georgia
- University Cancer & Blood Center, LLC ( Site 0057) - Athens
- Emory University Winship Cancer Institute ( Site 0012) - Atlanta
Michigan
- Henry Ford Hospital ( Site 0038) - Detroit
- Cancer & Hematology Centers of Western Michigan ( Site 0018) - Grand Rapids
Alabama
- The University of Alabama at Birmingham ( Site 0010) - Birmingham
Connecticut
- Hartford Hospital ( Site 0024) - Hartford
Florida
- Advent Health Hematology & Oncology ( Site 0003) - Orlando
Illinois
- Rush University Medical Center ( Site 0040) - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,653 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2026-10-29 |
| Phase | Phase 3 |
What the registry record for NCT04736706 still lists
NCT04736706 is an interventional study that assigns participants to a tested intervention. Its 1,653 participants enrollment target places it among the larger protocols in the corpus, above the 235-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (603% higher).
The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04736706 names 20 study sites across 12 states, led by California, Massachusetts, Georgia.
Frequently Asked Questions
What is clinical trial NCT04736706 about?
NCT04736706 is a clinical study titled "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)". The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary...
What is the current status of trial NCT04736706?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,653 participants. The study started on 2021-04-14. Estimated completion is 2026-10-29.
What conditions does trial NCT04736706 study?
This clinical trial studies the following conditions: Carcinoma, Renal Cell.
What interventions are being tested in trial NCT04736706?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Belzutifan (DRUG), Lenvatinib (DRUG), Pembrolizumab/Quavonlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04736706?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04736706 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04736706's enrollment target sits among peer trials
1,653 2nd of 34 the highest of 34 other Carcinoma, Renal Cell trials
participants (enrollment target), bucketed by value
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