Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy in the Management of Gleason Group 5 Prostate Cancer
NCT: NCT03543189 ·
Status: ACTIVE NOT RECRUITING ·
Phase: Phase 2
· Sponsor: H. Lee Moffitt Cancer Center and Research Institute
· Started: 2018-10-03
· Est. Completion: 2026-12
Official Summary
The purpose of this study is to test the safety, tolerability, and effectiveness of the investigational drug nivolumab (Opdivo™) in combination with high dose radiation. Investigators also want to see if these study drugs help to delay the progression of prostate cancer.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 44 participants
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.
Primary Outcomes
- Phase 1: Safety Run In - Rate of Dose Limiting Toxicity (CTCAE V5.0) (Up to 12 weeks after initiation of Nivolumab)
- Phase II: Relapse Free Survival Rate (Up to 2 years)
Secondary Outcomes
- Time to PSA Nadir (Up to 2 years)
Trial Locations
- H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.