Spots Global Cancer Trial Database for ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
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Trial Identification
Brief Title: ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Official Title: ENVASARC: A Pivotal Trial Of Envafolimab, And Envafolimab In Combination With Ipilimumab, In Patients With Advanced Or Metastatic Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma Who Have Progressed On Prior Chemotherapy
Study ID: NCT04480502
Study Description
Brief Summary: This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.
Detailed Description: This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic UPS/MFS who have progressed on one or two lines of chemotherapy. Patients were previously assigned at random into one of two cohorts: cohort A of 80 patients who received single agent envafolimab (300 mg every 3 weeks by subcutaneous (SC) injection) or cohort B of 80 patients who received envafolimab (300 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment #3, patients will be assigned at random into one of two cohorts: cohort C of 80 patients who will receive single agent envafolimab (600 mg every 3 weeks by subcutaneous (SC) injection) or cohort D of 80 patients who will receive envafolimab 600 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment #4, enrollment into cohort D was terminated and no further interim analyses will be conducted on this cohort.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona, Tucson, Arizona, United States
University of California, Los Angeles, Los Angeles, California, United States
Sarcoma Oncology Research Center, Santa Monica, California, United States
Stanford University, Stanford, California, United States
University of Colorado, Aurora, Colorado, United States
Mayo Clinic, Jacksonville, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Northwestern University, Evanston, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Columbia University, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University, Durham, North Carolina, United States
University Hospitals, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University (Sidney Kimmel Cancer Center), Philadelphia, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Medical College of Wisconsin, Wauwatosa, Wisconsin, United States
Royal Marsden, London, , United Kingdom
Contact Details
Name: Charles Theuer, MD, PhD
Affiliation: Tracon Pharmaceuticals Inc.
Role: STUDY_DIRECTOR
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