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NCT06483334 · ClinicalTrials.gov registry record · 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)

A Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 1
Development phase
38
Enrollment target
20
Study locations

NCT06483334: Active Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by Merck Sharp & Dohme.

NCT06483334 is a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 38 participants, below the 129-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06483334, a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
38 participants
Enrollment target
20
Study locations

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.

Primary Outcome

A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0). The number of participants who experience a DLT in Part 1 will be reported.

Conditions Studied

Metastatic Urothelial Carcinoma Locally 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
Merck Sharp & Dohme

558 total trials

What the registry record for NCT06483334 still lists

NCT06483334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 129-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (71% lower).

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.

NCT06483334 names 20 study sites across 13 states, led by Other, Ontario, California.

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.

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).

Who is sponsoring clinical trial NCT06483334?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Metastatic Urothelial Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06483334's enrollment target sits among peer trials

38 19th of 30 higher than 11 of 30 other Metastatic Urothelial Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06483334, the US trial registry maintained by the National Library of Medicine. NCT06483334 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.