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Brief Title: A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)
Official Title: A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma
Study ID: NCT06307431
Brief Summary: The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yale-New Haven Hospital-Yale Cancer Center ( Site 0102), New Haven, Connecticut, United States
Memorial Sloan Kettering Cancer Center ( Site 0100), New York, New York, United States
Fox Chase Cancer Center ( Site 0111), Philadelphia, Pennsylvania, United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 1502), Macquarie University, New South Wales, Australia
Westmead Hospital-Department of Medical Oncology ( Site 1501), Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si, Brisbane, Queensland, Australia
BC Cancer Vancouver ( Site 0005), Vancouver, British Columbia, Canada
CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 0008), Québec, Quebec, Canada
FALP-UIDO ( Site 1202), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 1205), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 1201), Santiago, Region M. De Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 1200), Viña del Mar, Valparaiso, Chile
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1701), Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
China Medical University Hospital-Department of Urology ( Site 1702), Taichung, , Taiwan
Taipei Veterans General Hospital ( Site 1703), Taipei, , Taiwan
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR