Clinical Trials /

Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma

NCT03341806

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.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Glioblastoma
  • GBM

Interventions

DrugSynonymsArms
AvelumabPatients 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

NameTypeDescriptionInterventions
Patients with Recurrent GlioblastomaExperimentalPart A - Avelumab Part B - Avelumab + MRI-guided LITT therapy
  • Avelumab

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically proven GBM from the initial resection.

          -  Tumor volume ≤ 3 cm3

          -  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 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

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