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Purpose

The purpose of this study is to learn if intismeran autogene 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 intismeran autogene with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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
Intismeran autogene + Pembrolizumab 		Participants receive up to 9 doses of intismeran autogene 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: Intismeran autogene
    IM injection
    Other names:
    • mRNA-4157
    • Individualized neoantigen therapy
    • V940
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • Keytruda®
Active Comparator
Placebo + Pembrolizumab 		Participants receive up to 9 doses of dose matched placebo to intismeran autogene 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

More Details

Status
Active, not recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.