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Brief Title: An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
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)
Study ID: NCT03897881
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, District of Columbia, United States
Orlando Health UF Health Cancer Center, Orlando, Florida, 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, Saint 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
St John of God Hospital Subiaco, Subiaco, Western Australia, Australia