Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
GCO 17-1866
- NCT ID:
NCT03341806
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Avelumab | | Patients with Recurrent Glioblastoma |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Patients with Recurrent Glioblastoma | Experimental | Part A - Avelumab Part B - Avelumab + MRI-guided LITT therapy | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose Limiting Toxicity level |
Time Frame: | 4 weeks |
Safety Issue: | |
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. |
Secondary Outcome Measures
Measure: | Progression-free survival |
Time Frame: | 6 months |
Safety Issue: | |
Description: | The % of progression free survival at 6 months |
Measure: | Overall response rate |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Overall response rate (proportion of partial and complete responses) will be evaluated according to Rano criteria. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Icahn School of Medicine at Mount Sinai |
Trial Keywords
- GBM
- LITT
- Laser Interstitial Thermal Therapy
- Bavencio
- immunotherapy
Last Updated
September 2, 2020