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Brief Title: A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Official Title: GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM
Study ID: NCT03970447
Brief Summary: Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.
Detailed Description: Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. Its goals are to identify effective therapies for glioblastoma and match effective therapies with patient subtypes. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to Arms based on their performance. The primary endpoint is overall survival (OS). GBM AGILE is designed to efficiently evaluate therapies. The trial will be conducted under a single Master Investigational New Drug Application/Clinical Trial Application and Master Protocol, allowing multiple drugs and drug combinations from different pharmaceutical companies to be evaluated simultaneously. The plan is to add experimental therapies as new information about promising new drugs are identified and remove therapies as they complete their evaluation.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of California, San Diego, La Jolla, California, United States
Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
University of California, Los Angeles, Los Angeles, California, United States
St. Joseph Hospital, Orange, California, United States
University of California, San Francisco, San Francisco, California, United States
Stanford Cancer Center, Stanford, California, United States
University of Colorado Denver, Aurora, Colorado, United States
Yale Cancer Center / Smilow Cancer Hospital, New Haven, Connecticut, United States
Mayo Clinic Cancer Center, Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Piedmont Atlanta Hospital, Atlanta, Georgia, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
LSU Health Sciences Center - New Orleans, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Abbott Northwestern Hospital, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center - Rochester, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Perlmutter Cancer Center, NYU Langone Health, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, 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
Duke University Medical Center, Durham, North Carolina, United States
Comprehensive Cancer Center of Wake Forest, Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University Cancer Center, Columbus, Ohio, United States
University of Pennsylvania - Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina - Hollings Cancer Center, Charleston, South Carolina, United States
Texas Oncology - Austin, Austin, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Virginia Health, Charlottesville, Virginia, United States
University of Washington Medical Center, Seattle, Washington, United States
Froedtert Hospital/Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Northern Sydney Cancer Centre/Royal North Shore Hospital, St Leonards, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Austin Health, Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital, McGill University, Montréal, Quebec, Canada
Université de Sherbrooke, Sherbrooke, Quebec, Canada
Centre Hospitalier Lyon Sud / Hôpital Neurologique P. Wertheimer, Bron, , France
Hopital de la Timone, Marseille, , France
Hopital Piti-Salpetriere, Paris, , France
Uniklinik Koeln - Zentrum fuer Neurologie und Psychiatrie, Cologne, , Germany
Dr. Senckenbergisches Institut für Neuroonkologie, Frankfurt, , Germany
Universitätsklinik Heidelberg, Heidelberg, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne, Vaud, Switzerland
Universitätsspital Basel, Basel, , Switzerland
University Hospital Zurich, Zürich, , Switzerland
Name: Tim Cloughesy, MD
Affiliation: GCAR CMO and GBM AGILE Global PI
Role: PRINCIPAL_INVESTIGATOR