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NCT06305767Recruiting

A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)

A Phase 2, Randomized, Double-blind, Placebo- and Active-comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection
Merck Sharp & Dohme LLCPhase 2ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Bladder Cancer
Drug/Device/Intervention
Pembrolizumab
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Location
Orlando,Macquarie University,Nedlands,Montréal,Quebec City,Santiago,Viña del Mar,Paris,Munich,Bydgoszcz,Koszalin,Madrid,Pozuelo de Alarcon,Sevilla,Uppsala, Australia,Canada,Chile,France,Germany,Poland,Spain,Sweden,United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Mar 28, 2024
End date
Apr 08, 2031
Enrollment
200 participants
Primary outcome

Disease Free Survival (DFS)

Summary

The purpose of this study is to assess the safety and efficacy of V940 in combination with
 pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for
 participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after
 radical resection. The primary study hypothesis is that V940 in combination with
 pembrolizumab results in a superior disease-free survival (DFS) as assessed by the
 investigator compared to pembrolizumab alone in participants with high-risk MIUC after
 radical resection.

ICD-10 classifications
Malignant neoplasm of bladderMalignant neoplasm: Bladder, unspecifiedMalignant neoplasm: Dome of bladderMalignant neoplasm: Overlapping lesion of bladderMalignant neoplasm: Lateral wall of bladder
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06305767
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06305767 through Pure Global AI's free database. This Phase 2 trial is sponsored by Merck Sharp & Dohme LLC and is currently Recruiting. The study focuses on Bladder Cancer. Target enrollment is 200 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.