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)
Public ClinicalTrials.gov record NCT04626518. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B in Second-Line Metastatic Participants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04626518
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 370 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- MK-4830 Biological
- Belzutifan Drug
- Lenvatinib Drug
- Pembrolizumab/Quavonlimab Biological
- Favezelimab/Pembrolizumab Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 16, 2020
- Primary completion
- Aug 20, 2026
- Completion
- Aug 20, 2026
- Last update posted
- Jul 29, 2026
2020 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at San Francisco ( Site 3008) | San Francisco | California | 94158 | — |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 3011) | New Haven | Connecticut | 06510 | — |
| University of Chicago ( Site 3013) | Chicago | Illinois | 60637 | — |
| University of Iowa ( Site 3012) | Iowa City | Iowa | 52242 | — |
| Henry Ford Health System ( Site 3014) | Detroit | Michigan | 48202 | — |
| Laura and Isaac Perlmutter Cancer Center ( Site 3016) | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center ( Site 3002) | New York | New York | 10065 | — |
| Duke Cancer Institute ( Site 3015) | Durham | North Carolina | 27710 | — |
| UPMC Cancer Center/Hillman Cancer Center ( Site 3017) | Pittsburgh | Pennsylvania | 15232 | — |
| Vanderbilt University Medical Center ( Site 3004) | Nashville | Tennessee | 37232 | — |
| UTSW Medical Center ( Site 3003) | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04626518, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2026 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04626518 live on ClinicalTrials.gov.