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

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ClinicalTrials.gov Identifier: NCT06305767
Recruitment Status : Recruiting
First Posted : March 12, 2024
Last Update Posted : May 23, 2024
Sponsor:
Collaborator:
ModernaTX, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Biological: Pembrolizumab Biological: V940 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 28, 2024
Estimated Primary Completion Date : October 8, 2026
Estimated Study Completion Date : April 8, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab + V940
Participants receive 400 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 400 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06305767


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
ModernaTX, Inc.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
Additional Information:
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT06305767    
Other Study ID Numbers: V940-005
V940-005 ( Other Identifier: Merck )
U1111-1292-1952 ( Other Identifier: WHO )
2023-505658-17 ( Other Identifier: EU CT )
First Posted: March 12, 2024    Key Record Dates
Last Update Posted: May 23, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme LLC:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action