Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

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

Sponsor

Merck Sharp & Dohme

558 total trials

Interested in This Trial?

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, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (71% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Metastatic Urothelial Carcinoma

All registered trials for this condition

Locally Advanced Urothelial Carcinoma

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.