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NCT07049926 · ClinicalTrials.gov registry record · Phase 1

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)

A Phase 1 study of Renal Cell Carcinoma, sponsored by Merck Sharp & Dohme.

Recruiting
Registry status
Phase 1
Development phase
140
Enrollment target
20
Study locations

NCT07049926: Recruiting Phase 1 study of Renal Cell Carcinoma, sponsored by Merck Sharp & Dohme.

NCT07049926 is a Phase 1 study of Renal Cell Carcinoma that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 140 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07049926, a Phase 1 study of Renal Cell Carcinoma, is actively recruiting participants, sponsored by Merck Sharp & Dohme.

RECRUITING
Registry status
Phase 1
Development phase
140 participants
Enrollment target
20
Study locations

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

Primary Outcome

DLTs are defined as any of a pre-specified list of toxicities if assessed by the investigator to be possibly, probably, or definitely related to study treatment administration, excluding toxicities clearly not related to the drug, such as disease progression, environmental factors, unrelated trauma, etc.

Conditions Studied

Renal Cell Carcinoma

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

FieldValue
Enrollment Target 140 participants
Start Date 2025-07-20
Est. Completion 2031-10-26
Phase Phase 1
Merck Sharp & Dohme

558 total trials

What NCT07049926 shows while recruiting

NCT07049926 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (42% lower).

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.

NCT07049926 names 20 study sites across 13 states, led by Other, New York, Region M. de Santiago.

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.

What interventions are being tested in trial NCT07049926?

The interventions under investigation include: Belzutifan (DRUG), Zanzalintinib (DRUG).

Who is sponsoring clinical trial NCT07049926?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Renal Cell Carcinoma

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.

Where NCT07049926's enrollment target sits among peer trials

140 41st of 121 higher than 81 of 121 other Renal Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Renal Cell Carcinoma 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07049926

Source: ClinicalTrials.gov NCT07049926, the US trial registry maintained by the National Library of Medicine. NCT07049926 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.