Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

PHASE2Active, not recruitingINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

December 8, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2026

Conditions

GlioblastomaGliosarcomaMalignant Glioma

Interventions

DRUG

TMZ

150 mg/m2 on days 1-5 of cycles 1-6

DRUG

ipilimumab 3mg/kg

3 mg/kg q 4 weeks for cycles 1-4

DRUG

Nivolumab

1 mg/kg IV q2weeks for cycles 1-4, then 480 mg q 4 weeks for cycles 5-16

DRUG

ipilimumab 1mg/kg

1 mg/kg q 4 weeks for cycles 1-4

Trial Locations (1)

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors

lead

National Cancer Institute (NCI)

NIH