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Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Sponsor: Institut de Recherches Internationales Servier
Summary
Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
331
Start Date
2020-01-05
Completion Date
2028-05
Last Updated
2025-04-03
Healthy Volunteers
No
Interventions
Vorasidenib
Vorasidenib oral film-coated tablets
Matching Placebo
Matching Placebo oral tablets
Locations (84)
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
University of California San Diego
La Jolla, California, United States
UCLA Oncology Center
Los Angeles, California, United States
University of California Irvine - 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 Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Maine Medical Partners Neurology
Scarborough, Maine, United States
John Hopkins Cancer Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Metro Minnesota Community Oncology
Minneapolis, Minnesota, United States
Mayo Comprehensive Cancer
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, 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
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
The University of Utah, Huntsman Cancer Hospital
Salt Lake City, Utah, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
BC Cancer Agency
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Lille
Lille, France
Hôpital Pierre Wertheimer
Lyon, France
Hopitaux de La Timone
Marseille, France
Hospitalier Pitié Salpétrière
Paris, France
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Klinikum Mannheim Universitätsklinikum
Mannheim, Germany
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Ospedale Bellaria
Bologna, Italy
Istituto Oncologico Veneto - I.R.C.C.S.
Padua, Italy
Istituto Nazionale Tumori Regina Elena
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Hiroshima University Hospital
Minami-Ku, Hiroshima, Japan
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
Kumamoto University Hospital
Kumamoto, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan
Kyoto University Hospital
Kyoto, Japan
Okayama University Hospital
Okayama, Japan
Haaglanden MC, Antoniushove
Leidschendam, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Hospital Universitario Vall d'Hebrón
Barcelona, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hôpitaux Universitaire de Genève
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Western General Hospital Edinburgh - PPDS
Edinburgh, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom