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NCT05562830

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)

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
Merck Sharp & Dohme LLC·Phase 1/2·ClinicalTrials.gov·biologicalRecruiting
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Study focus
Disease/Condition
Urothelial Carcinoma
Drug/Device/Intervention
Zilovertamab vedotin
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Location
Brisbane,Haifa,Petah Tikva,Ramat Gan,Seoul,Seoul,Seoul,Barcelona,Madrid, Australia,Israel,South Korea,Spain
Timeline & enrollment
Phase
Phase 1/2
Start date
Nov 16, 2022
End date
Oct 28, 2027
Enrollment
40 participants
Primary outcome

Percentage of Participants Who Experienced At Least One Adverse Event (AE),Percentage of Participants Who Discontinued Study Treatment Due to an AE,Objective Response Rate (ORR)

Summary

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.

ICD-10 classifications
Carcinoma in situ: Other and unspecified urinary organsMalignant neoplasm of ureterMalignant neoplasms of urinary tractMalignant neoplasm: Overlapping lesion of urinary organsMalignant neoplasm: Urethra
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05562830
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05562830 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Merck Sharp & Dohme LLC and is currently Recruiting. The study focuses on Urothelial Carcinoma. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.