Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM

PHASE1RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2027

Conditions
Glioblastoma
Interventions
RADIATION

Radiation Therapy

Standard radiotherapy (approximately 60 Gy over 6 weeks)

BIOLOGICAL

Personalized NeoAntigen Peptides

NeoVax Vaccine (Personalized NeoAntigen Peptides + Poly-ICLC) will be administered on an individual basis using a dosing schedule that incorporates both priming and boost phases.

DRUG

Pembrolizumab

Pembrolizumab will be administered every 3 weeks at a flat dose of 200 mg intravenously. Pembrolizumab should be administered as a 30 minute IV infusion (Pembrolizumab treatment cycle intervals may be increased due to toxicity per protocol).

DRUG

Temozolomide

Concurrent Temozolomide (TMZ) = 75 mg/m2/day for 6 weeks, administered with XRT

DRUG

Temozolomide

Adjuvant Temozolomide (TMZ) = 150 mg/m2/day on days 1-5 of each 28-day cycle for up to 6 adjuvant cycles

BIOLOGICAL

Poly-ICLC

NeoVax Vaccine (Personalized NeoAntigen Peptides + Poly-ICLC) will be administered on an individual basis using a dosing schedule that incorporates both priming and boost phases.

Trial Locations (2)

02113

NOT_YET_RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Dana Farber Cancer Institute, Boston

All Listed Sponsors
collaborator

The Ben & Catherine Ivy Foundation

OTHER

collaborator

Accelerate Brain Cancer Cure

OTHER

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

National Institutes of Health (NIH)

NIH

lead

Dana-Farber Cancer Institute

OTHER