T-Cell Responses to Neoantigens Post Treatment With Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT02113657
- Phase
- EARLY_PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ipilimumab — DRUG3 mg/kg by vein once every 3 weeks for a total of 4 doses.
Study Details
The goal of this clinical research study is to study the impact of ipilimumab on the immune system of patients currently receiving hormone therapy. The safety of these drug combinations will also be studied. This is an investigational study. Ipilimumab is FDA approved and commercially available for the treatment of melanoma. Its use to treat prostate cancer is investigational. Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.
Key Dates
- Start date
- Aug 20, 2014
- Status verified
- May 2024
- Primary completion
- Nov 4, 2019
- Completion
- Nov 4, 2019
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: IpilimumabIpilimumab administered by vein at a dose of 3 mg/kg once every 3 weeks for a total of 4 doses.
Primary Outcome Measure
Impact of Ipilimumab on T Cell Responses to prostate cancer neoantigens in both primary tumor and metastatic sites in men with metastatic CRPC [ Time Frame: 10 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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