Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03422094
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NeoVax — BIOLOGICAL
    At each vaccination time point, patients will receive up to 20 synthetic long peptides co-administered with 1.5 mg of poly-ICLC divided into a maximum of four injections (pools). Each pool (of vaccine + poly IC:LC) will be administered to one of the four limbs (right axilla, left axilla, right inguina, left inguina) by subcutaneous injection.
  • Nivolumab — BIOLOGICAL
    Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
  • Ipilimumab — BIOLOGICAL
    Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)
  • Research blood draw — PROCEDURE
    -Baseline, cycle 2 day 1, cycle 4 day 1, and time of progression or discontinuation of treatment
  • Leukapheresis for research — PROCEDURE
    -Baseline, cycle 4 day 1, and time of progression or discontinuation of treatment

Study Details

This is a single institution, open-label, multi-arm, pilot study assessing the safety, feasibility, and immunogenicity of a personalized neoantigen-based vaccine plus poly-ICLC (NeoVax) combined with immune checkpoint inhibitors in subjects with newly diagnosed, unmethylated glioblastoma.

Key Dates

Start date
Oct 31, 2018
Status verified
Oct 2021
Primary completion
Apr 26, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: NeoVax+Nivolumab (start at time of progression)
    * NeoVax given on Days 1, 8, 15, and 22 of Cycle 1 (priming phase), and then on Day 1 of each subsequent cycle (boosting phase) * Nivolumab 480 mg i.v. given on Day 1 of each cycle beginning at time of progression
  • Experimental: Cohort B: NeoVax+Nivolumab (start with Cycle 2)
    * NeoVax given on Days 1, 8, 15, and 22 of Cycle 1 (priming phase), and then on Day 1 of each subsequent cycle (boosting phase) * Nivolumab 480 mg i.v. given on Day 1 of each cycle beginning with Cycle 2 (start of boosting phase)
  • Experimental: Cohort C: NeoVax + Nivolumab (start with Cycle 1)
    * NeoVax given on Days 1, 8, 15, and 22 of Cycle 1 (priming phase), and then on Day 1 of each subsequent cycle (boosting phase) * Nivolumab 480 mg i.v. given on Day 1 of Cycle 1 (priming phase), and then on Day 1 of each subsequent cycle (boosting phase)
  • Experimental: Cohort D: NeoVax+Ipilimumab+Nivolumab (start with Cycle 3)
    * NeoVax given on Days 1, 8, 15, and 22 of Cycle 1 (priming phase), and then on Day 1 of each subsequent cycle (boosting phase) * Ipilimumab 1 mg/kg i.v. given on Days 1 and 22 of Cycle 1 (priming phase) * Nivolumab 480 mg i.v. given on Day 1 of Cycle 3 and then on Day 1 of each subsequent cycle
  • Experimental: Cohort E: NeoVax+Ipilimumab+Nivolumab (day 1&15 each cycle)
    * NeoVax given on Days 1, 8, 15, and 22 of Cycle 1 (priming phase), and then on Day 1 of each subsequent cycle (boosting phase) * Ipilimumab 1 mg/kg i.v. given every 6 weeks beginning on Day 1 of Cycle 1 (C1D1, C2D15, C4D1, C5D15, C7D1, C8D15 …) * Nivolumab 3 mg/kg i.v. given on Days 1 and 15 of each cycle (q2w) beginning on Day 1 of Cycle 1

Primary Outcome Measure

Safety and tolerability of regimen as measured by a <= 33% dose-limiting toxicity (DLT) rate for a given cohort [ Time Frame: Up to 90 days after start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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