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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03341806
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase Phase 1
Start date June 13, 2018
Completion date October 13, 2021

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