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ACTIVE NOT RECRUITING
NCT03897881
PHASE2

An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (KEYNOTE- 942)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

267

Start Date

2019-07-18

Completion Date

2032-11-30

Last Updated

2025-12-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

mRNA-4157

Individualized Neoantigen Therapy

BIOLOGICAL

Pembrolizumab

Intravenous infusion

Locations (23)

University of Arizona

Tucson, Arizona, United States

California Pacific Medical Center Research Institute -CPMCRI

San Francisco, California, United States

Angeles Clinic and Research Institute

Santa Monica, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Smilow Cancer Center at Yale New Haven Hospital

New Haven, Connecticut, United States

Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Orlando Health UF Health Cancer Center

Orlando, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

UPMC Hillman Cancer Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

NYU Langone Medical Center

New York, New York, United States

Providence Cancer Institute

Portland, Oregon, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Texas Oncology PA

Dallas, Texas, United States

Melanoma Institute Australia

North Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Affinity Clinical Research

Murdoch, Western Australia, Australia

One Clinical Research Perth

Murdoch, Western Australia, Australia

St John of God Hospital Subiaco

Subiaco, Western Australia, Australia