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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.
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
mRNA-4157
Individualized Neoantigen Therapy
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