Pilot Study of SBRT and CDX-1127 in Prostate Cancer
- Conditions
- Prostatic NeoplasmsProstate Cancer
- Registration Number
- NCT02284971
- Lead Sponsor
- James Larner, MD
- Brief Summary
This study evaluates the combination of stereotactic body radiation therapy (SBRT) and CDX-1127 in subjects with castration resistant prostate cancer. Subjects will be randomized to one of three arms to receive SBRT prior to, after, or in conjunction with the first dose of CDX-1127.
- Detailed Description
This pilot study will be conducted in subjects with metastatic prostate cancer in order to define whether inclusion of immune regulation agents such as CDX-1127 augments immune responses to SBRT-treated primary tumors or metastases, and whether inclusion of CDX-1127 in the treatment regimen results in immune responses in untreated metastases.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 2
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Immunologic (CD8+ T cell and T regulatory cell (Treg) infiltration) Up to day 43 • Estimate the effect of SBRT, CDX-1127 and the combination of SBRT and CDX- 1127 on CD8+ T cell and T regulatory cell (Treg) infiltration in prostate tumors.
Number of adverse events Up to day 270
- Secondary Outcome Measures
Name Time Method Immunologic (lymphocyte composition of blood over time). Up to day 270 • Estimate the effect of SBRT, CDX-1127, and the combination of SBRT and CDX-1127 on the lymphocyte composition of blood over time.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Virginia🇺🇸Charlottesville, Virginia, United States