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A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005) - Trial NCT06305767

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.

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NCT06305767
Phase 2
Recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06305767
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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

Study Focus

Bladder Cancer

Pembrolizumab

Interventional

biological

Sponsor & Location

Merck Sharp & Dohme LLC

Orlando,Macquarie University,Nedlands,Montrรฉal,Quebec City,Santiago,Viรฑa 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 2

Mar 28, 2024

Apr 08, 2031

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 bladder
Malignant neoplasm: Bladder, unspecified
Malignant neoplasm: Dome of bladder
Malignant neoplasm: Overlapping lesion of bladder
Malignant neoplasm: Lateral wall of bladder

Data Source

ClinicalTrials.gov

NCT06305767

Non-Device Trial