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Brief Title: Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma
Official Title: Phase I Study of PD-L1 Inhibition With Avelumab and Laser Interstitial Thermal Therapy in Patients With Recurrent Glioblastoma
Study ID: NCT03341806
Brief Summary: The purpose of the study is to characterize the safety and tolerability of avelumab in combination with Laser Interstitial Thermal Therapy (LITT) for blood barrier disruption in patients with recurrent glioblastoma.
Detailed Description: This is an open label, non-randomized Phase I study of intravenous avelumab every 2 weeks to be administered after real-time MRI-guided LITT therapy for patients with a first recurrence of a glioblastoma. The primary objective of the study is to characterize the tolerability and safety profile of avelumab in combination with MRI guided LITT administered to patients diagnosed with recurrent GBM. Part A, the initial cohort of patients will be treated with intravenous avelumab alone. Part B, patients will receive avelumab in combination with MRI-guided LITT to characterize the tolerability and safety of the combined treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Name: Adilia Hormigo, MD, PhD
Affiliation: Icahn School of Medicine at Mount Sinai
Role: PRINCIPAL_INVESTIGATOR