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Brief Title: A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected Pancreatic Ductal Adenocarcinoma
Official Title: A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma
Study ID: NCT05968326
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
USC Norris Cancer Center; USC Oncology Hematology Newport Beach, Newport Beach, California, United States
University of California, San Francisco (UCSF), San Francisco, California, United States
University of California Los Angeles, Santa Monica, California, United States
St. Francis Hospital and Medical Center, Hartford, Connecticut, United States
Smilow Cancer Center, New Haven, Connecticut, United States
Yale Cancer Center; CLINICAL RESEARCH SUPPORT LABORATORY (CRSL), New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Trumbull, Trumbull, Connecticut, United States
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center, Boston, Massachusetts, United States
Boston Medical Center (BMC) - Cancer Care Center, Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center; MSK Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Bergen, Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center - Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center at Westchester, Harrison, New York, United States
Northwell Health; Monter Cancer Center, Lake Success, New York, United States
NYU Langone Health, Mineola, New York, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center at Nassau, Uniondale, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Miriam Hospital, Providence, Rhode Island, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
St Michael Hospital; Hematology and Oncology, Toronto, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
University Hospitals Birmingham NHS Foundation Trust; QEHB Pharmacy Department, Birmingham, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR