Clinical trial NCT03341806: Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma
Official title: Phase I Study of PD-L1 Inhibition With Avelumab and Laser Interstitial Thermal Therapy in Patients With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioblastoma
GBM
Keywords: GBM
LITT
Laser Interstitial Thermal Therapy
Bavencio
immunotherapy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dose Limiting Toxicity level
timeFrame: 4 weeks
measure: Objective response rate (ORR)
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 6 months
measure: Overall response rate
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Adilia Hormigo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: