Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

NCT03341806 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GCO 17-1866
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; GBM

Keywords

GBM; LITT; Laser Interstitial Thermal Therapy; Bavencio; immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Progression-free survival

  6 months

• Overall response rate

  6 months

Study Arms (1)

Patients with Recurrent Glioblastoma

EXPERIMENTAL

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

Drug: Avelumab; Combination Product: MRI-guided LITT therapy

Interventions

Avelumab DRUG

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

Patients with Recurrent Glioblastoma

MRI-guided LITT therapy COMBINATION_PRODUCT

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

Patients with Recurrent Glioblastoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

avelumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Adilia Hormigo, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 14, 2017
• Study Start: June 13, 2018
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)