An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
NCT03897881 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 267
Last updated 2025-12-03
Summary
The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.
Conditions
Interventions
- DRUG
-
Individualized Neoantigen Therapy
- BIOLOGICAL
-
Intravenous infusion
Sponsors & Collaborators
- collaborator INDUSTRY
-
ModernaTX, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-18
- Primary Completion
- 2032-11-30
- Completion
- 2032-11-30
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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