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Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
NCT07049926 · View on ClinicalTrials.gov ↗
Study Summary
Substudy 03C 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 03C is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with clear cell renal cell carcinoma (ccRCC) who have recurrent disease during or after anti-programmed cell death 1/programmed cell death ligand 1 (PD-\[L\]1) adjuvant therapy. 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
Conditions Studied
Interventions
- DRUG Belzutifan
- DRUG Zanzalintinib
Study Locations (20)
Other
- Rambam Health Care Campus ( Site 5500) — Haifa
- Rabin Medical Center ( Site 5502) — Petah Tikva
- Sheba Medical Center ( Site 5501) — Ramat Gan
- Sourasky Medical Center ( Site 5503) — Tel Aviv
- Severance Hospital ( Site 5802) — Seoul
New York
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5026) — Mineola
- Laura and Isaac Perlmutter Cancer Center ( Site 5016) — New York
- Memorial Sloan Kettering Cancer Center ( Site 5002) — New York
Region M. de Santiago
- Centro de Estudios Clínicos SAGA ( Site 6110) — Santiago
- Bradfordhill ( Site 6101) — Santiago
California
- UCSF Medical Center at Mission Bay ( Site 5008) — San Francisco
North Carolina
- Duke Cancer Institute ( Site 5015) — Durham
Pennsylvania
- UPMC Cancer Center/Hillman Cancer Center ( Site 5017) — Pittsburgh
Bas-Rhin
- C.H.U. de Strasbourg Hopital de Hautepierre ( Site 5203) — Strasbourg
Haute-Garonne
- Institut Claudius Regaud ( Site 5200) — Toulouse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2025-07-20 |
| Est. Completion | 2031-10-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07049926
The ClinicalTrials.gov registry entry for NCT07049926 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Belzutifan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07049926 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, New York, Region M. de Santiago. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07049926 about?
NCT07049926 is a clinical study titled "Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)". Substudy 03C 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 03C is to evaluate the safety and efficacy of experimental combinations of investigational agents in participant...
What is the current status of trial NCT07049926?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2025-07-20. Estimated completion is 2031-10-26.
What conditions does trial NCT07049926 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07049926?
The interventions under investigation include: Belzutifan (DRUG), Zanzalintinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07049926?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07049926 being conducted?
This trial has 20 study locations across California, New York, North Carolina, Pennsylvania, Region M. de Santiago. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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