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

April 24, 2024 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research ( Site 1807)
        • Contact:
          • Study Coordinator
          • Phone Number: +61862799466
  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal ( Site 0005)
        • Contact:
          • Study Coordinator
          • Phone Number: 5148908000
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Recruiting
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
        • Contact:
          • Study Coordinator
          • Phone Number: 4185254444
  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: 48501446778
  • Spain
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Recruiting
        • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914521987
  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 205-520-6512

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab + V940
Participants receive 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of every 6-week cycle for up to 9 cycles, plus 1 mg of V940 via intramuscular (IM) injection once available every 3 weeks up to a total of 9 doses. V940 doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.
Biological: Pembrolizumab
Administered via IV infusion at a dose of 400 mg on Day 1 of every 6-week cycle (Q6W) for up to 9 cycles.
Other Names:
  • MK-3475
  • Keytruda®
Biological: V940
Administered via IM injection at a dose of 1 mg every 3 weeks (Q3W) for up to 9 doses.
Active Comparator: Pembrolizumab + Placebo
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 6-week cycle for up to 9 cycles. Placebo will be administered every 3 weeks up to a total of 9 doses. The total duration of treatment is up to approximately 13 months.
Biological: Pembrolizumab
Administered via IV infusion at a dose of 400 mg on Day 1 of every 6-week cycle (Q6W) for up to 9 cycles.
Other Names:
  • MK-3475
  • Keytruda®
Other: Placebo
V940 diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS)
Time Frame: Up to approximately 28 months
DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (≥pT2) disease in the urothelial tract (upper tract or lower tract) or high grade T1 disease in the upper tract on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for each arm.
Up to approximately 28 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 28 months
Overall survival is defined as the time from randomization to death due to any cause. OS will be reported for each arm.
Up to approximately 28 months
Distant Metastasis-Free Survival (DMFS)
Time Frame: Up to approximately 28 months
DMFS is defined as the time from randomization until death from any cause, or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy, per investigator assessment. DMFS will be reported for each arm.
Up to approximately 28 months
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 16 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience AEs will be reported for each arm.
Up to approximately 16 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 13 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an adverse event will be presented. The number of participants who discontinue study treatment due to an AE will be reported for each arm.
Up to approximately 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

ModernaTX, Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2024

Primary Completion (Estimated)

October 8, 2026

Study Completion (Estimated)

April 8, 2031

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V940-005 (Other Identifier: Merck)
  • U1111-1292-1952 (Other Identifier: WHO)
  • 2023-505658-17 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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