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NCT04626518 · ClinicalTrials.gov registry record · Phase 1
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)
A Phase 1 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 1
- Development phase
- 370
- Enrollment target
- 20
- Study locations
NCT04626518: Active Phase 1 study of Carcinoma, Renal Cell, sponsored by Merck Sharp & Dohme.
NCT04626518 is a Phase 1 study of Carcinoma, Renal Cell that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 370 participants, above the 272-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (36% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04626518, a Phase 1 study of Carcinoma, Renal Cell, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 370 participants
- Enrollment target
- 20
- Study locations
Study Summary
Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC). This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.
Primary Outcome
DLTs are defined as one or more of the following toxicities: (1) grade (gr) 4 nonhematologic toxicity (2) gr 4 hematologic toxicity lasting \>7 days OR gr 4 platelet count decreased of any duration OR gr 3 platelet count decreased if associated with bleeding (3) gr 3 nonhematologic toxicity except gr 3 fatigue (lasting ≤3 days), diarrhea, nausea, vomiting or rash without standard of care (4) gr 3 or 4 nonhematologic abnormality if medical intervention is required or if it leads to hospitalizatio
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Belzutifan
- DRUG Lenvatinib
- BIOLOGICAL MK-4830
- BIOLOGICAL Pembrolizumab/Quavonlimab
Study Locations (20)
New York
- Laura and Isaac Perlmutter Cancer Center ( Site 3016) - New York
- Memorial Sloan Kettering Cancer Center ( Site 3002) - New York
New South Wales
- Blacktown Hospital ( Site 3601) - Blacktown
- St George Hospital ( Site 3602) - Kogarah
Region M. de Santiago
- FALP-UIDO ( Site 4100) - Santiago
- Bradfordhill-Clinical Area ( Site 4101) - Santiago
California
- University of California at San Francisco ( Site 3008) - San Francisco
Connecticut
- Yale-New Haven Hospital-Yale Cancer Center ( Site 3011) - New Haven
Illinois
- University of Chicago ( Site 3013) - Chicago
Iowa
- University of Iowa ( Site 3012) - Iowa City
Michigan
- Henry Ford Health System ( Site 3014) - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
What the registry record for NCT04626518 still lists
NCT04626518 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, above the 272-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (36% higher).
The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04626518 names 20 study sites across 17 states, led by New York, New South Wales, Region M. de Santiago.
Frequently Asked Questions
What is clinical trial NCT04626518 about?
NCT04626518 is a clinical study titled "Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)". Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participant...
What is the current status of trial NCT04626518?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 370 participants. The study started on 2020-12-17. Estimated completion is 2026-05-31.
What conditions does trial NCT04626518 study?
This clinical trial studies the following conditions: Carcinoma, Renal Cell.
What interventions are being tested in trial NCT04626518?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Belzutifan (DRUG), Lenvatinib (DRUG), MK-4830 (BIOLOGICAL), Pembrolizumab/Quavonlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04626518?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04626518 being conducted?
This trial has 20 study locations across California, Connecticut, Illinois, Iowa, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04626518's enrollment target sits among peer trials
370 8th of 34 higher than 27 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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