Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03661723
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
  • Bevacizumab — DRUG
    Bevacizumab (also known as "Avastin") is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
  • Re-irradiation — RADIATION
    Radiotherapy destroys cancer cells using radiation aimed at a cancer from a machine

Study Details

This research study is studying pembrolizumab and re-irradiation as possible treatments for glioblastoma. The drugs involved in this study are: * Pembrolizumab * Radiation * Bevacizumab, an FDA-approved drug for treating recurrent glioblastoma multiforme (GBM)

Key Dates

First listed
Sep 7, 2018
Start date
Sep 28, 2018
Status verified
Aug 2024
Primary completion
Dec 9, 2021
Completion
Aug 1, 2024

Study Design

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

Arms

  • Experimental: Pembrolizumab + Radiation (lead-in)
    * Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks. (De-escalation dosing frequencies = once every 4 weeks and once every 6 weeks.) * Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
  • Experimental: Pembrolizumab + Bevacizumab + Radiation (lead-in)
    * Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks. (De-escalation dosing frequencies = once every 4 weeks and once every 6 weeks.) * Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks * Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
  • Experimental: Pembrolizumab + Radiation
    * Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks * Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks
  • Experimental: Pembrolizumab + Bevacizumab + Radiation
    * Pembrolizumab (200 mg) will initially be administered intravenously (IV) once every 3 weeks * Bevacizumab (15 mg/kg) will be administered intravenously (IV) once every 3 weeks * Re-irradiation (35 Gy) will be administered to patients 5 days per week for 2 weeks

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02214-
Columbia University / Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Hospital of the University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104-

Find similar trials in Boston, MA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Beth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAColumbia University / Herbert Irving Comprehensive Cancer Center· New York, NYHospital of the University of Pennsylvania, Abramson Cancer Center· Philadelphia, PA

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