Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03543189
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.
  • Brachytherapy — RADIATION
    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.
  • External Beam Radiation Therapy — RADIATION
    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.
  • Androgen Deprivation Therapy — DRUG
    Standard of care.

Study Details

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.

Key Dates

Start date
Oct 3, 2018
Status verified
Mar 2026
Primary completion
Jun 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy
    Post androgen deprivation therapy (ADT), participants will receive nivolumab, HDR brachytherapy and external beam radiation therapy, followed by a 2 year follow-up period.

Primary Outcome Measure

Phase 1: Safety Run In - Rate of Dose Limiting Toxicity (CTCAE V5.0) [ Time Frame: Up to 12 weeks after initiation of Nivolumab ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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