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ACTIVE NOT RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • BIOLOGICAL Sacituzumab tirumotecan
  • BIOLOGICAL Pembrolizumab
  • DRUG Supportive care measures
  • BIOLOGICAL Enfortumab Vedotin

Study Locations (20)

Other

  • Rambam Health Care Campus ( Site 4501) — Haifa
  • Rabin Medical Center-Oncology ( Site 4504) — Petah Tikva
  • Sheba Medical Center-ONCOLOGY ( Site 4503) — Ramat Gan
  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 4405) — Milan
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 4406) — Naples
  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4903) — Seoul
  • Asan Medical Center-Department of Oncology ( Site 4901) — Seoul

Ontario

  • The Ottawa Hospital - General Campus ( Site 4105) — Ottawa
  • Princess Margaret Cancer Centre ( Site 4106) — Toronto

California

  • University of California San Francisco HDFCCC ( Site 4044) — San Francisco

Illinois

  • University of Chicago Medical Center ( Site 4037) — Chicago

Indiana

  • Indiana University Melvin and Bren Simon Cancer Center ( Site 4011) — Indianapolis

Massachusetts

  • Dana-Farber Cancer Institute ( Site 4047) — Boston

Missouri

  • Siteman Cancer Center ( Site 4038) — St Louis

New York

  • Icahn School of Medicine at Mount Sinai ( Site 4018) — New York

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2024-07-17
Est. Completion 2028-03-31
Phase Phase 1

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06483334

The ClinicalTrials.gov registry entry for NCT06483334 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 4 interventions — of which Sacituzumab tirumotecan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06483334 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Ontario, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06483334 about?

NCT06483334 is a clinical study titled "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)". 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...

What is the current status of trial NCT06483334?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2024-07-17. Estimated completion is 2028-03-31.

What conditions does trial NCT06483334 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06483334?

The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Pembrolizumab (BIOLOGICAL), Supportive care measures (DRUG), Enfortumab Vedotin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06483334?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06483334 being conducted?

This trial has 20 study locations across California, Illinois, Indiana, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial