Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

Mount Sinai Health System

Status and phase

Completed

Phase 1

Conditions

Glioblastoma

GBM

Treatments

Combination Product: MRI-guided LITT therapy

Drug: Avelumab

Study type

Interventional

Funder types

Other

Identifiers

NCT03341806

GCO 17-1866

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have histologically proven GBM from the initial resection.
Patients must have a life expectancy > 16 weeks. Patients must have a Karnofsky performance status of ≥ 60 or ECOG 0 - 2
Patient's requirement for dexamethasone should be ≤ 4mg daily or a stable dose at enrollment.
Patients must have adequate bone marrow, hepatic and renal function and hemoglobin and the test musts be performed within 14 days prior to study Day 1.
Highly effective contraception for both male and female subjects if the risk of conception exists.

Exclusion criteria

Known history of autoimmune disorder except diabetes mellitus type 1, vitiligo or hypothyroidism only requiring hormone replacement
Patients who have received any other therapeutic investigational agent within 30 days of enrollment with the exception of the personalized MTA vaccine (NCT03223103) that can be continued throughout the study.
Patients who have received any other therapeutic investigational agent within 30 days of enrollment or prior
Prior placement of intracavitary BCNU-impregnated wafers (Gliadel).
Prior treatment with checkpoint inhibitors, CTL-4 antibody or other immunotherapy agents
Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment.
Prior organ transplantation, including allogeneic stem cell transplantation
Significant acute or chronic infections including, among others: HIV, AIDS, HBV
Pregnancy or lactation

Contact site for full inclusion/exclusion list.