NCT03576612 - GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 27, 2018

Primary Completion Date

June 30, 2023

Study Completion Date

June 30, 2023

Conditions

Glioma, Malignant

Interventions

BIOLOGICAL

AdV-tk

Given IT

DRUG

Valacyclovir

Given PO days 1-14; 1-3 days post surgery

RADIATION

Radiation

Undergo RT, 60Gy in 30 daily fractions M-F for 6weeks

DRUG

Temozolomide

Given PO during RT 75mg/m2 daily during RT Post RT cycle 1: 150mg/m2 days 1-5 150mg/m2 cycle 2-6: days 1-5 (150-200mg/m2)

BIOLOGICAL

Nivolumab

day 15 post surgery 240mg IV q2wks x 26 doses , up to 52 weeks

OTHER

Laboratory Biomarker Analysis

correlative studies

Trial Locations (5)

Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh

Abrams Cancer Center of the University of Pennsylvania, Philadelphia

Wake Forest University Comprehensive Cancer Center, Winston-Salem

Henry Ford Hospital, Detroit

Dana Farber Cancer Institute, Boston