Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341806
• Other study ID #: GCO 17-1866
• Status: Completed
• Phase: Phase 1
• Start date: June 13, 2018
• Est. completion date: October 13, 2021

Study information

• Verified date: December 2021
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GBM
• Glioblastoma

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	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)	6 months
Secondary	Progression-free survival	The % of progression free survival at 6 months	6 months
Secondary	Overall response rate	Overall response rate (proportion of partial and complete responses) will be evaluated according to Rano criteria.	6 months