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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Avelumab will be administered intravenously every 2 weeks at a dose of 10 mg/kg for 2 cycles
(Part B) prior to receiving Avelumab 10 mg/kg every 2 weeks + LITT
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Dose Limiting Toxicity level
Toxicity will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale.
Time frame: 4 weeks
Objective response rate (ORR)
Tumor response to treatment with avelumab in combination with MRI-guided LITT administered to patients with recurrent GBM by estimation of the objective response rate (ORR) -classified according to the RANO Response Criteria (Proportion of Complete Response, Partial Response, Stable Disease and Progressive Disease)
Time frame: 6 months
Progression-free survival
The % of progression free survival at 6 months
Time frame: 6 months
Overall response rate
Overall response rate (proportion of partial and complete responses) will be evaluated according to Rano criteria.
Time frame: 6 months
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