Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Washington University School of Medicine
Study ID
NCT03532295
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Epacadostat — DRUG
    -All BID doses will be taken in the morning and evening, approximately 12 hours apart
  • Bevacizumab — DRUG
    -The first infusion will be over the course of 90 minutes; if tolerated, the second infusion will be over the course of 60 minutes; if tolerated, all subsequent infusions will be over 30 minutes
  • Radiation therapy — RADIATION
    -The gross tumor maximum diameter (to be irradiated) to be \</= 6 cm in the first 6 patients. If more than 1 target is irradiated, then the sum of all the target maximum diameters should be \</= 6 cm. No more than 3 separate targets for RT is allowed.
  • Retifanlimab — DRUG
    -Will be supplied by Incyte

Study Details

In this study, the investigators propose to combine retifanlimab with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). The investigators hypothesize that this combination provides a powerful synergy between RT and immune modulators to produce more robust anti-tumor immune response, induce tumor regression and improve overall survival.

Key Dates

Start date
Apr 20, 2020
Status verified
Nov 2025
Primary completion
Jul 26, 2024
Completion
Oct 31, 2025

Study Design

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

Arms

  • Experimental: Regimen A: Retifanlimab+RT+bevacizumab
    * Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle. * Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle. * Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction * Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy * Treatment may continue for up to two years.
  • Experimental: Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
    * Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle. * Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle. * Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction * Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy * Epacadostat will be administered orally at 400 mg BID. * Treatment may continue for up to two years.

Primary Outcome Measure

Kaplan-Meier Estimate of Overall Survival (OS) at 9 Months [ Time Frame: At 9 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85259-
Mayo ClinicRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-

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