Who is eligible for clinical trial NCT06483334?

Participants must meet protocol criteria for Metastatic Urothelial Carcinoma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06483334 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-02-16

A Study of Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Plus Enfortumab Vedotin (EV) With and Without Pembrolizumab in Advanced Urothelial Carcinoma (MK-3475-04C/KEYMAKER-U04) (NCT06483334)

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

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

This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the safety and preliminary efficacy of sacituzumab tirumotecan plus enfortumab vedotin (EV). Part 2 will be based on Part 1 results and will evaluate the efficacy, pharmacokinetics, and safety of sacituzumab tirumotecan plus EV in combination with pembrolizumab in participants with advanced urothelial carcinoma.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (19 items).

Location: University of California San Francisco HDFCCC ( Site 4044) — San Francisco, California

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

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

The main inclusion criteria include but are not limited to the following:
Must have histologically documented, locally advanced/metastatic urothelial carcinoma (la/mUC).
Must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation. A newly obtained biopsy is strongly preferred, but not required if archival tissue is evaluable.
Any AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Endocrine-related AEs adequately treated with hormone replacement are eligible.
PART 1 ONLY: Participants must have received platinum-based chemotherapy for treatment of la/mUC.
PART 1 ONLY: Participants must not have received \>2 lines of therapy for la/mUC. Platinum-based chemotherapy followed by avelumab maintenance is considered 2 lines of therapy.
PART 2 ONLY: Participants must not have received prior systemic therapy for la/mUC.

Usually NOT eligible if any of the following apply:

Exclusion Criteria: The main exclusion criteria include but are not limited to the following:
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Known active central nervous system metastases and/or carcinomatous meningitis.
Has Grade ≥2 peripheral neuropathy.
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease and/or serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
Has active keratitis or corneal ulcerations. Superficial punctate keratitis is allowed if the disorder is being adequately treated in the opinion of the investigator.
Has a history of uncontrolled diabetes.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
PART 2 ONLY: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (25 Sites)

University of California San Francisco HDFCCC ( Site 4044) — San Francisco, California
University of Chicago Medical Center ( Site 4037) — Chicago, Illinois
Indiana University Melvin and Bren Simon Cancer Center ( Site 4011) — Indianapolis, Indiana
Dana-Farber Cancer Institute ( Site 4047) — Boston, Massachusetts
Siteman Cancer Center ( Site 4038) — St Louis, Missouri
Icahn School of Medicine at Mount Sinai ( Site 4018) — New York, New York
Cleveland Clinic-Taussig Cancer Center ( Site 4036) — Cleveland, Ohio
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 4041) — Salt Lake City, Utah
The Ottawa Hospital - General Campus ( Site 4105) — Ottawa, Ontario
Princess Margaret Cancer Centre ( Site 4106) — Toronto, Ontario
Centre Hospitalier Lyon Sud ( Site 4606) — Pierre-Bénite, Auvergne-Rhône-Alpes
Rambam Health Care Campus ( Site 4501) — Haifa,
Rabin Medical Center-Oncology ( Site 4504) — Petah Tikva,
Sheba Medical Center-ONCOLOGY ( Site 4503) — Ramat Gan,
Ospedale San Raffaele-Oncologia Medica ( Site 4403) — Milan, Lombardy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 4405) — Milan,
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 4406) — Naples,
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 4302) — Amsterdam, North Holland
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4903) — Seoul,
Asan Medical Center-Department of Oncology ( Site 4901) — Seoul,
Samsung Medical Center ( Site 4902) — Seoul,
Hospital Universitari Vall d'Hebron-Oncology ( Site 4767) — Barcelona,
Hospital Clinico San Carlos ( Site 4765) — Madrid,
National Cheng Kung University Hospital-Clinical Trial Center ( Site 4803) — Tainan,
St Bartholomew s Hospital ( Site 4206) — London, London, City of

💰 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.

🏛️ View Official NIH Record ↗