Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
David Peereboom
Study ID
NCT04013672
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    200 mg IV every 3 weeks
  • SurVaxM — DRUG
    500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
  • Sargramostim — DRUG
    100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
  • Montanide ISA 51 — DRUG
    1 ml per dose dosed every two weeks for 4 doses and then every 3 months

Study Details

The main purpose of this study is to assess the clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma.

Key Dates

Start date
Mar 19, 2020
Status verified
Aug 2024
Primary completion
Aug 16, 2021
Completion
Feb 16, 2022

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Have not received immunotherapy
    Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
  • Experimental: Arm B - Have failed prior anti-PD1 therapy
    Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 6 months from start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterClevelandOhio44195-

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