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Brief Title: Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma
Official Title: A Phase II, Open-label, Single Arm, Multicenter Study of Avelumab With Hypofractionated Radiation in Adult Subjects With Transformed IDH Mutant Glioblastoma
Study ID: NCT02968940
Brief Summary: The purpose of this study is to test how safe and effective treatment with the combination of Avelumab and radiation is for IDH mutant gliomas that have transformed to glioblastoma after chemotherapy.
Detailed Description: The active pharmaceutical ingredient in Avelumab (MSB0010718C) is a fully human antibody of the immunoglobulin gamma-1 (IgG1) isotype that specifically targets and blocks the Programmed death-ligand 1(PD-L1) for Programmed cell death protein 1 (PD-1). Avelumab binds PD-L1 and blocks the interaction between PD-L1 and PD-1. This removes the suppressive effects of PD-L1 on anti-tumor cluster of differentiation 8 (CD8)+ T cells, resulting in the restoration of cytotoxic T cell response.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California, Los Angeles (UCLA), Los Angeles, California, United States
UCSF Medical Center, San Francisco, California, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Laura & Isaac Perlmutter Cancer Center & NYU Langone Medical Center, New York, New York, United States
Name: Sylvia Kurz, MD
Affiliation: NYU Perlmutter Cancer Center
Role: PRINCIPAL_INVESTIGATOR