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) - Trial NCT05562830
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.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme LLC
Timeline & Enrollment
Phase 1/2
Nov 16, 2022
Oct 28, 2027
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
Data Source
ClinicalTrials.gov
NCT05562830
Non-Device Trial