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A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling
Phase 3

Conditions

Melanoma

Treatments

Biological: Pembrolizumab
Biological: V940
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05933577
jRCT2041230169 (Registry Identifier)
2023-503652-27-00 (Other Identifier)
V940-001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

Enrollment

1,089 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
  • Has not received any prior systemic therapy for their melanoma beyond surgical resection
  • No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
  • Is disease free at the time of providing documented consent for the study
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has ocular or mucosal melanoma
  • Has cancer that has spread to other parts of the body and cannot be removed with surgery
  • Has heart failure within the past 6 months
  • Has received prior cancer therapy or another cancer vaccine
  • Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
  • Has severe reaction to study medications or any of their substance used to prepare a drug
  • Have not recovered from major surgery or have ongoing surgical complications

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,089 participants in 2 patient groups

V940 + Pembrolizumab
Experimental group
Description:
Participants receive up to 9 doses of V940 via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
Treatment:
Biological: Pembrolizumab
Biological: V940
Placebo + Pembrolizumab
Active Comparator group
Description:
Participants receive up to 9 doses of dose matched placebo to V940 via an IM injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
Treatment:
Other: Placebo
Biological: Pembrolizumab

Trial contacts and locations

158

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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