A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

September 12, 2022

Study Completion Date

October 27, 2023

Conditions
Newly Diagnosed High Grade Glioma
Interventions
DRUG

Temozolomide

concomitant and 5-day adjuvant temozolomide

RADIATION

conformal brain radiation therapy

standard radiation therapy for newly diagnosed glioblastoma

DRUG

Nivolumab

nivolumab 240 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks

DRUG

Ipilimumab

ipilimumab 1 mg/kg IV every 6 weeks (or every 8 weeks when nivolumab is administered every 4 weeks) for a maximum of 4 doses

DRUG

Bevacizumab

bevacizumab 5 mg/kg IV every 2 weeks (up to 10 mg/kg at treating physician's discretion)

DRUG

5-day Temozolomide

150 mg/m\^2 oral, once daily on Days 1-5 of each 28-day cycle (stepwise titration every cycle up to 200 mg/m\^2 permitted)

DRUG

5-day Temozolomide

100 mg/m\^2 oral, once daily on Days 2-6 of each 6 week course (stepwise titration every cycle up to 200 mg/m\^2 permitted)

DRUG

Lomustine

100 mg/m\^2 oral, on Day 1 of each 6 week course

DRUG

Nivolumab monotherapy

nivolumab 300 mg IV every 2 weeks for the first 28-day cycle, then option to modify to 480 mg IV every 4 weeks

Trial Locations (1)

90404

Saint John's Cancer Institute, Santa Monica

All Listed Sponsors
lead

Saint John's Cancer Institute

OTHER

NCT03425292 - A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer | Biotech Hunter | Biotech Hunter