Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT04201873
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Dendritic Cell Tumor Cell Lysate Vaccine — BIOLOGICAL
    Given ID
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Placebo Administration — OTHER
    Given IV
  • Poly ICLC — DRUG
    Given IM

Study Details

This phase I trial studies the side effects and how well of pembrolizumab and a vaccine therapy (ATL-DC vaccine) work in treating patients with glioblastoma that has come back (recurrent) and can be removed by surgery (surgically accessible). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Vaccines, such as ATL-DC vaccine, may help the body build an effective immune response to kill tumor cells. Giving pembrolizumab and ATL-DC vaccine may work better in treating patients with glioblastoma compared to ATL-DC alone.

Key Dates

First listed
Dec 17, 2019
Start date
Jan 8, 2020
Status verified
Aug 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (pembrolizumab, ATL-DC, poly ICLC)
    Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Group B (placebo, ATL-DC, poly ICLC)
    Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Cell cycle-related signature [ Time Frame: Up to 6 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
QuanLos AngelesCalifornia90095-

Find similar trials in Los Angeles, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Quan· Los Angeles, CA

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