🏛️ Verified NIH Record • Updated 2026-07-14

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)

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: UCSF Medical Center at Mission Bay ( Site 5008) — San Francisco, California

Age range: 18 Years to 120 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (30 Sites)

Showing the first 25 of 30 sites.

  • UCSF Medical Center at Mission Bay ( Site 5008) — San Francisco, California
  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5026) — Mineola, New York
  • Laura and Isaac Perlmutter Cancer Center ( Site 5016) — New York, New York
  • Memorial Sloan Kettering Cancer Center ( Site 5002) — New York, New York
  • Duke Cancer Institute ( Site 5015) — Durham, North Carolina
  • UPMC Cancer Center/Hillman Cancer Center ( Site 5017) — Pittsburgh, Pennsylvania
  • Vanderbilt University Medical Center ( Site 5004) — Nashville, Tennessee
  • Centro de Estudios Clínicos SAGA ( Site 6110) — Santiago, Region M. de Santiago
  • Bradfordhill ( Site 6101) — Santiago, Region M. de Santiago
  • C.H.U. de Strasbourg Hopital de Hautepierre ( Site 5203) — Strasbourg, Bas-Rhin
  • Institut Claudius Regaud ( Site 5200) — Toulouse, Haute-Garonne
  • Centre Eugene Marquis ( Site 5205) — Rennes, Ille-et-Vilaine
  • Institut De Cancerologie De Lorraine ( Site 5204) — Vandœuvre-lès-Nancy, Meurthe-et-Moselle
  • Gustave Roussy ( Site 5202) — Villejuif, Île-de-France Region
  • 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,
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 6201) — Bydgoszcz, Kuyavian-Pomeranian Voivodeship
  • Uniwersyteckie Centrum Kliniczne ( Site 6202) — Gdansk, Pomeranian Voivodeship
  • Severance Hospital ( Site 5802) — Seoul,
  • Asan Medical Center ( Site 5800) — Seoul,
  • Samsung Medical Center ( Site 5801) — Seoul,
  • Hospital Universitario Ramon y Cajal ( Site 5301) — Madrid, Madrid, Comunidad de
  • Hospital Universitari Vall d'Hebron ( Site 5300) — Barcelona,

📞 Contact the Study Coordinator

Phone: (888) 577-8839

Email: Trialsites@msd.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗