Nivolumab With DC Vaccines for Recurrent Brain Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

September 15, 2017

Study Completion Date

December 30, 2019

Conditions
Malignant GliomaAstrocytomaGlioblastoma
Interventions
DRUG

nivolumab

Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cluster of differentiation 279 cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes. Binding of PD-1 to its ligands, programmed death-ligands 1 and 2, results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T cell responses to both foreign antigens as well as self-antigens. Nivolumab is expressed in Chinese hamster ovary cells and is produced using standard mammalian cell cultivation and chromatographic purification technologies. The clinical study product is a sterile solution for parenteral administration.

BIOLOGICAL

DC

DCs are potent immunostimulatory cells that continuously sample the antigenic environment of the host and specifically activate cluster of differentiation 4 positive (CD4+) and cluster of differentiation 8 positive (CD8+) T-cells and B-cells. They are at the crossroads of many of the elegant networks of the immune system, and DCs represent the most promising contemporary biologic entity for realizing the promise of immunotherapy. Potent immune responses and encouraging clinical results have been seen in Phase I and II human clinical trials in systemic cancers. Numerous animal studies and the investigator's institution's humans studies have demonstrated potent antitumor responses using DC-based immunotherapy against MGs.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Duke Cancer Institute

OTHER

lead

Gary Archer Ph.D.

OTHER