Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

NCT ID: NCT03341806

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-13
• Study Completion Date: 2021-10-13

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.

Conditions

Glioblastoma; GBM

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Recurrent Glioblastoma

Part A - Avelumab Part B - Avelumab + MRI-guided LITT therapy

Group Type: EXPERIMENTAL

Avelumab

Intervention Type: DRUG

Avelumab will be administered intravenously every 2 weeks at a dose of 10 mg/kg for 2 cycles

MRI-guided LITT therapy

Intervention Type: COMBINATION_PRODUCT

(Part B) prior to receiving Avelumab 10 mg/kg every 2 weeks + LITT

Interventions

Avelumab

Avelumab will be administered intravenously every 2 weeks at a dose of 10 mg/kg for 2 cycles

Intervention Type: DRUG

MRI-guided LITT therapy

(Part B) prior to receiving Avelumab 10 mg/kg every 2 weeks + LITT

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Adilia Hormigo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adilia Hormigo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 17-1866

Identifier Type: -

Identifier Source: org_study_id