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ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Sponsor: Tracon Pharmaceuticals Inc.
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.
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
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
207
Start Date
2020-12-09
Completion Date
2024-10
Last Updated
2024-05-17
Healthy Volunteers
No
Interventions
Envafolimab
PD-L1 single domain antibody for subcutaneous injection.
Ipilimumab
CTLA-4 monoclonal antibody
Locations (30)
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
St 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