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Brief Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702)
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1+ Synovial Sarcoma Participants Following First Line Systemic Anti-cancer Therapy (V943-003, IMDZ-04-1702)
Study ID: NCT03520959
Brief Summary: To assess if the CMB305 vaccine regimen may help the body's immune system to slow or stop the growth of synovial sarcoma tumor and improve survival.
Detailed Description: The Synovate Study is a global, randomized, double-blind, placebo-controlled, phase 3 study in patients with unresectable, locally-advanced or metastatic New York esophageal squamous cell carcinoma 1 (NY-ESO-1) positive synovial sarcoma following first-line systemic anti-cancer therapy.
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic- Scottsdale, Scottsdale, Arizona, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Stanford University, Palo Alto, California, United States
Sarcoma Oncology Center, Santa Monica, California, United States
University of Colorado Cancer Center, Boulder, Colorado, United States
Yale University School of Medicine- Cancer Center, New Haven, Connecticut, United States
University of Miami, Coral Gables, Florida, United States
Mayo Clinic- Jacksonville, Jacksonville, Florida, United States
Moffitt Cancer Center at USF, Tampa, Florida, United States
Northwestern, Chicago, Illinois, United States
Dana Farber Cancer Institute/Mass General Hospital, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Hackensack University Medical Center, Edison, New Jersey, United States
Cohen Children's Medical Center (Northwell), Astoria, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University, Durham, North Carolina, United States
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Alberta Hospital- Cross Cancer Institute, Edmonton, , Canada
McGill University, Montréal-Est, , Canada