Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (NCT04626479)
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A in First Line Metastatic Participants
🩺 Plain-English Summary (8th-Grade Level)
Substudy 03A 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 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) 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.
Who can join: Review the eligibility criteria below.
Location: University of California at San Francisco ( Site 1008) — San Francisco, California
Age range: 18 Years to 120 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (55 Sites)
Showing the first 25 of 55 sites.
- University of California at San Francisco ( Site 1008) — San Francisco, California
- Yale-New Haven Hospital-Yale Cancer Center ( Site 1011) — New Haven, Connecticut
- University of Chicago ( Site 1013) — Chicago, Illinois
- University of Iowa ( Site 1012) — Iowa City, Iowa
- Henry Ford Health System ( Site 1014) — Detroit, Michigan
- Laura and Isaac Perlmutter Cancer Center ( Site 1016) — New York, New York
- Memorial Sloan Kettering Cancer Center ( Site 1002) — New York, New York
- Duke Cancer Institute ( Site 1015) — Durham, North Carolina
- UPMC Cancer Center/Hillman Cancer Center ( Site 1017) — Pittsburgh, Pennsylvania
- UTSW Medical Center ( Site 1003) — Dallas, Texas
- Blacktown Hospital ( Site 1601) — Blacktown, New South Wales
- St George Hospital ( Site 1602) — Kogarah, New South Wales
- Royal Brisbane and Women's Hospital ( Site 1603) — Herston, Queensland
- Austin Health ( Site 1600) — Heidelberg, Victoria
- Princess Margaret Cancer Centre ( Site 1101) — Toronto, Ontario
- Jewish General Hospital ( Site 1100) — Montreal, Quebec
- James Lind Centro de Investigacion del Cancer ( Site 2108) — Temuco, Araucania
- CIDO SpA-Oncology ( Site 2106) — Temuco, Araucania
- FALP-UIDO ( Site 2100) — Santiago, Region M. de Santiago
- Oncovida ( Site 2107) — Santiago, Region M. de Santiago
- Bradfordhill-Clinical Area ( Site 2101) — Santiago, Region M. de Santiago
- ONCOCENTRO APYS-ACEREY ( Site 2103) — Viña del Mar, Valparaiso
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1900) — Bogotá, Bogota D.C.
- Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1905) — Valledupar, Cesar Department
- Instituto Médico de Alta Tecnologia S.A.S ( Site 1904) — Montería, Departamento de Córdoba
💰 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.
More studies in Carcinoma, Renal Cell
- A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) — Chandler, Arizona
- 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) — San Francisco, California
- A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) — Birmingham, Alabama
- A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) — Phoenix, Arizona
- Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies (CTC Immune Based Biomarkers) — Durham, North Carolina
Explore by condition: All Carcinoma, Renal Cell clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.