A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer

Summary

The purpose of this study is to test the safety and tolerability of the research study drugs nivolumab, ipilimumab, lomustine, bevacizumab, and temozolomide when used following surgery and before standard therapy with radiation and temozolomide in patients with newly diagnosed high grade glioma.

Additional aims of the study are to:

* Find out side effects (good and bad) of study drug combinations.
* Evaluate any preliminary evidence of anticancer activity of study drug combinations .
* Evaluate tumor characteristics by collecting brain tumor tissue samples.
* Measure the amount of nivolumab and ipilimumab in biospecimens.
* Look at biomarkers in biospecimens.

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

Sponsors & Collaborators

• Saint John's Cancer Institute

  lead OTHER

Principal Investigators

• Santosh Kesari, MD, PhD · Saint John's Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-01

Primary Completion

2022-09-12

Completion

2023-10-27

FDA Drug

Yes

Countries

• United States

Study Locations