A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A) (NCT05562830)
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A
🩺 Plain-English Summary (8th-Grade Level)
This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.
Who can join: Review the eligibility criteria below.
Location: University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045) — Orange, California
Age range: 18 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 (28 Sites)
Showing the first 25 of 28 sites.
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045) — Orange, California
- University of California San Francisco ( Site 1044) — San Francisco, California
- Anschutz Cancer Pavilion ( Site 1017) — Aurora, Colorado
- University of Chicago Medical Center ( Site 1037) — Chicago, Illinois
- Indiana University Melvin and Bren Simon Cancer Center ( Site 1011) — Indianapolis, Indiana
- Siteman Cancer Center ( Site 1038) — St Louis, Missouri
- Memorial Sloan Kettering Cancer Center ( Site 1031) — New York, New York
- Cleveland Clinic-Taussig Cancer Center ( Site 1036) — Cleveland, Ohio
- UPMC Hillman Cancer Center ( Site 1014) — Pittsburgh, Pennsylvania
- Huntsman Cancer Institute ( Site 1041) — Salt Lake City, Utah
- Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 1952) — Brisbane, Queensland
- Princess Margaret Cancer Centre ( Site 1106) — Toronto, Ontario
- FALP-UIDO ( Site 1151) — Santiago, Region M. de Santiago
- Bradford Hill ( Site 1155) — Santiago, Region M. de Santiago
- Rigshospitalet-Dept. of Oncology ( Site 1701) — Copenhagen, Capital Region
- Rambam Health Care Campus-Oncology ( Site 1501) — Haifa,
- Rabin Medical Center-Oncology ( Site 1504) — Petah Tikva,
- Sheba Medical Center-ONCOLOGY ( Site 1503) — Ramat Gan,
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1408) — Milan, Lombardy
- Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1406) — Naples,
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1302) — Amsterdam, North Holland
- Severance Hospital, Yonsei University Health System ( Site 1903) — Seoul,
- Asan Medical Center ( Site 1901) — Seoul,
- Samsung Medical Center ( Site 1902) — Seoul,
- Hospital Universitari Vall d'Hebron ( Site 1767) — Barcelona, Catalonia
📞 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.
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- Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma — Philadelphia, Pennsylvania
- A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma — Houston, Texas
- A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder — Bloomington, Indiana
- Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma — Oklahoma City, Oklahoma
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Explore by condition: All Urothelial Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.