Tremelimumab and Durvalumab in Combination or Alone in Treating Patients With Recurrent Malignant Glioma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT02794883
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative Studies
  • Surgical Procedure — PROCEDURE
    Undergo surgical tumor resection
  • Tremelimumab — BIOLOGICAL
    Given IV

Study Details

The main purpose of this trial is to investigate the effects of a new class of drugs that help the patient's immune system attack their tumor (glioblastoma multiforme - GBM). These drugs have already shown benefit in some other cancer types and are now being explored in GBM. Both tremelimumab and durvalumab (MEDI4736) are "investigational" drugs, which means that the drugs are not approved by the Food and Drug Administration (FDA). Both drugs are antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with glioblastoma.

Key Dates

Start date
Nov 1, 2016
Status verified
Mar 2022
Primary completion
May 9, 2018
Completion
Jun 17, 2020

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment (durvalumab)
    Patients receive durvalumab IV over 1 hour on days 1 and 15. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Treatment (tremelimumab and durvalumab)
    Patients receive tremelimumab IV over 1 hour on day 1 then durvalumab IV over 1 hour on days 1 and 15. Courses repeat every 4 weeks for up to 7 courses. Patients then receive both tremelimumab and durvalumab IV over 1 hour every 12 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Treatment (tremelimumab)
    Patients receive tremelimumab IV over 1 hour on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

T-cell (Immunologic) Changes in Blood [ Time Frame: From baseline up to end of treatment, where all patients received at least 1 dose pre-surgery, and range of cycles attempted post-surgery was 0-16 (1 Cycle = 4 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-

Find similar trials in Chicago, IL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Northwestern University· Chicago, IL

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