Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

October 3, 2018

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Prostate CancerProstate Disease
Interventions
DRUG

Nivolumab

Treatment with nivolumab will begin four weeks prior to the first brachytherapy treatment. Nivolumab will be given through a vein every 2 weeks for 4 courses. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, resulting in decreased tumor growth.

RADIATION

Brachytherapy

High dose rate (HDR) Brachytherapy involves the delivery of a high dose of radiation, internally, directly to the prostate. This procedure is completed in one day as an outpatient procedure.

RADIATION

External Beam Radiation Therapy

External beam radiation therapy to the participant's prostate will be given once a day, five days a week (Monday-Friday), for a total of five weeks. External radiation therapy treatments are given as an outpatient procedure and take about 10-15 minutes each day.

DRUG

Androgen Deprivation Therapy

Standard of care.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER