Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

October 31, 2018

Primary Completion Date

April 26, 2020

Study Completion Date

December 31, 2020

Conditions
Glioblastoma
Interventions
BIOLOGICAL

NeoVax

At each vaccination time point, patients will receive up to 20 synthetic long peptides co-administered with 1.5 mg of poly-ICLC divided into a maximum of four injections (pools). Each pool (of vaccine + poly IC:LC) will be administered to one of the four limbs (right axilla, left axilla, right inguina, left inguina) by subcutaneous injection.

BIOLOGICAL

Nivolumab

Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody

BIOLOGICAL

Ipilimumab

Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)

PROCEDURE

Research blood draw

-Baseline, cycle 2 day 1, cycle 4 day 1, and time of progression or discontinuation of treatment

PROCEDURE

Leukapheresis for research

-Baseline, cycle 4 day 1, and time of progression or discontinuation of treatment

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Washington University School of Medicine

OTHER