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Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

Primary Purpose

Glioblastoma, GBM

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Avelumab
MRI-guided LITT therapy
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring GBM, LITT, Laser Interstitial Thermal Therapy, Bavencio, immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Recurrent Glioblastoma

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

Progression-free survival
The % of progression free survival at 6 months
Overall response rate
Overall response rate (proportion of partial and complete responses) will be evaluated according to Rano criteria.

Full Information

First Posted
November 9, 2017
Last Updated
December 31, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03341806
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
October 13, 2021 (Actual)
Study Completion Date
October 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, GBM
Keywords
GBM, LITT, Laser Interstitial Thermal Therapy, Bavencio, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Recurrent Glioblastoma
Arm Type
Experimental
Arm Description
Part A - Avelumab Part B - Avelumab + MRI-guided LITT therapy
Intervention Type
Drug
Intervention Name(s)
Avelumab
Intervention Description
Avelumab will be administered intravenously every 2 weeks at a dose of 10 mg/kg for 2 cycles
Intervention Type
Combination Product
Intervention Name(s)
MRI-guided LITT therapy
Intervention Description
(Part B) prior to receiving Avelumab 10 mg/kg every 2 weeks + LITT
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity level
Description
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.
Time Frame
4 weeks
Title
Objective response rate (ORR)
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
The % of progression free survival at 6 months
Time Frame
6 months
Title
Overall response rate
Description
Overall response rate (proportion of partial and complete responses) will be evaluated according to Rano criteria.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adilia Hormigo, MD, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

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