NCT03341806

Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

Phase I Study of PD-L1 Inhibition With Avelumab and Laser Interstitial Thermal Therapy in Patients With Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma
• GBM

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab will be administered intravenously every 2 weeks at a dose of 10 mg/kg for 2 cycles
COMBINATION_PRODUCT	MRI-guided LITT therapy	(Part B) prior to receiving Avelumab 10 mg/kg every 2 weeks + LITT

Timeline

• Start date: 2018-06-13
• Primary completion: 2021-10-13
• Completion: 2021-10-13
• First posted: 2017-11-14
• Last updated: 2022-01-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study