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

Purpose

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.

Condition

  • Melanoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Double blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
V940 + Pembrolizumab 		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.
  • Biological: V940
    IM injection
    Other names:
    • mRNA-4157
    • Individualized neoantigen therapy
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • Keytruda®
Active Comparator
Placebo + Pembrolizumab 		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.
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • Keytruda®
  • Other: Placebo
    IM injection
    Other names:
    • Normal saline
    • Dextrose

Recruiting Locations

Massachusetts General Hospital ( Site 1927)
Boston, Massachusetts 02114
Contact:
Study Coordinator
617-643-3614

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com