Pembrolizumab +/- Bevacizumab for Recurrent GBM

Part of paid clinical trials in Los Angeles, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT02337491
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

In this research study, the investigators are looking to determine the effectiveness of Pembrolizumab (MK-3475) when given with bevacizumab or when given alone for the treatment of recurrent glioblastoma multiforme (GBM). This study will also test the safety and tolerability of Pembrolizumab (MK-3475) when given alone or with bevacizumab.

Key Dates

First listed
Jan 13, 2015
Start date
Feb 9, 2015
Status verified
Nov 2020
Primary completion
Aug 28, 2016
Completion
Sep 14, 2020

Study Design

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

Arms

  • Experimental: Cohort A Safety Lead-In: Pembrolizumab (DL 0) + Bevacizumab
    Pembrolizumab (Dose Level 0): 200 mg administered intravenously on days 1 and 22 of each 42 day cycle Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle Participants were treated until disease progression or unacceptable toxicity up to 16 cycles.
  • Experimental: Cohort A: Pembrolizumab + Bevacizumab
    Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle Bevacizumab: 10 mg/kg administered Intravenously on days 1, 15 and 29 of each 42 day cycle Participants were treated until disease progression or unacceptable toxicity up to 16 cycles.
  • Experimental: Cohort B: Pembrolizumab
    Pembrolizumab: 200 mg administered intravenously on days 1 and 22 of each 42 day cycle Participants were treated until disease progression or unacceptable toxicity up to 16 cycles.

Primary Outcome Measure

Pembrolizumab Maximum Tolerated Dose (MTD) [Cohort A Safety Lead-In] [ Time Frame: one cycle/42 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94143-0372-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02113-
Memorial Sloan-Kettering CancerNew YorkNew York10021-
Duke University Medical CenterDurhamNorth Carolina27710-
UT, MD Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Los Angeles, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of California, Los Angeles· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAMemorial Sloan-Kettering Cancer· New York, NYDuke University Medical Center· Durham, NC

Related Studies