Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

November 12, 2018

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Glioblastoma
Interventions
RADIATION

Re-irradiation (RT)

Re-RT will start on day 28 +/- 5 days for 5 fractions of 600cGy every other day over a 2-week period.

DRUG

Bevacizumab

Bevacizumab if deemed beneficial by the investigator, will be started at the initiation of re-RT and continued for three doses in the medical arm. Patients in the surgical arm will omit the first bevacizumab dose to assure adequate wound healing after surgery and receive two doses. Bevacizumab will be dosed at 10mg/kg and given intravenously on day 28 (medical arm only), day 42 and day 56. Following day 56, further bevacizumab doses can be given every two weeks at the discretion of the treating physician.

DRUG

Nivolumab

"Nivolumab will be started at enrollment and each patient will receive two doses of nivolumab prior to radiation.~Nivolumab will be dosed at 3mg/kg given intravenously before re-RT (day 1 +/- 5 and 14 +/- 5) and when given with bevacizumab if deemed beneficial by the investigator, (day 28 +/- 5 (medical arm only), day 42 +/- 5, and day 56 +/-5). Nivolumab will be dosed based on body weight while combined with re-radiation and bevacizumab for safety considerations to reduce adverse events. Single agent nivolumab will be given at 240mg flat dose every 2 weeks thereafter until disease progression, withdrawal, adverse event, or death."

PROCEDURE

Re-resection

Re-resection will be performed in the surgical arm at day 14 (+/- 5 days).

Trial Locations (12)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

18103

Lehigh Valley Health Network (Data Collection Only), Allentown

33143

Miami Cancer Institute Baptist Health South Florida (Data Collection Only), Miami

46202

Indiana University (Data Collection Only), Indianapolis

06102

Hartford Healthcare (Data Collection), Hartford

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

05401

University of Vermont Medical Center (Data Collection Only), Burlington

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03743662 - Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma | Biotech Hunter | Biotech Hunter