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

Conditions

• Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intismeran autogene — BIOLOGICAL
  IM injection
• Pembrolizumab — BIOLOGICAL
  IV infusion
• Placebo — OTHER
  IM injection

Study Details

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.

Key Dates

Start date

Jul 19, 2023

Status verified

Sep 2025

Primary completion

Oct 26, 2029

Completion

Sep 26, 2030

Study Design

Enrollment

1,089 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Recurrence-Free Survival (RFS) [ Time Frame: Up to approximately 74 months ]

Locations (34)

Find similar trials in Springdale, AR

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