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Brief Title: 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

INTRODUCTION

  • Org Study ID: V940-005
  • Secondary ID: N/A
  • NCT ID: NCT06305767
  • Sponsor: Merck Sharp & Dohme LLC

BRIEF 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.

  • Overall Status
    Recruiting
  • Start Date
    March 28, 2024
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
* Has muscle-invasive urothelial carcinoma (MIUC)

- * Has dominant histology of UC

- * Has high-risk pathologic disease after radical resection

- * Must provide formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS)

- * Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing

- * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
Exclusion Criteria:
* Has received prior systemic anticancer therapy

- * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

- * Has known additional malignancy that is progressing or has required active treatment <3 years prior to study randomization - * Has severe hypersensitivity to either V940 or pembrolizumab and/or any of their excipients - * Has current pneumonitis/interstitial lung disease - * Has active infection requiring systemic therapy - * Has active hepatitis B and hepatitis C virus infection

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: Toll Free Number

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102)
Orlando, Florida 32804
United States 		Status: Recruiting Contact: Contact
Study Coordinator
205-520-6512

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