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

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Melanoma

Treatments: Biological: Intismeran autogene; Biological: Pembrolizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05933577

jRCT2041230169 (Registry Identifier)

2023-503652-27 (Registry Identifier)

V940-001 (Other Identifier)

U1111-1287-6366 (Registry Identifier)

Details and patient eligibility

About

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.

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

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1,089 participants in 2 patient groups

Intismeran autogene + Pembrolizumab

Experimental group

Description:

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.

Treatment:

Biological: Pembrolizumab

Biological: Intismeran autogene

Placebo + Pembrolizumab

Active Comparator group

Description:

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.

Treatment:

Other: Placebo

Biological: Pembrolizumab