T-Cell Responses to Neoantigens Post Treatment With Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02113657|
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : January 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Ipilimumab||Early Phase 1|
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive ipilimumab by vein over about 90 minutes at Weeks 1, 4, 7, and 10. Your blood pressure will be measured every 30 minutes during the infusion, as well as an hour after you are finished receiving the study drug.
You will continue to receive your current hormone therapy as scheduled.
You will be given standard drugs (such as steroids) to help decrease severe side effects. You may ask the study staff for information about how the drugs are given and their risks.
You will have a study visit before each dose of ipilimumab, then every 4 weeks for a total of 3 visits after the last dose of ipilimumab. At each of these visits, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3 tablespoons) and urine will be collected for routine tests. This blood will also be used and to measure your protein, PSA levels.
- Blood (up to 7 tablespoons) and urine will be collected to test for biomarkers. (Weeks 7, 14, and 22 only)
- Blood (about 1½ teaspoons) will be drawn to check your testosterone level. (Week 10 only)
- Blood (up to 10 tablespoons) will be drawn to test your immune system. You will sign a separate consent form for this blood draw.
At Weeks 14 and 22, the following tests and procedures will be performed to check the status of the disease:
- You may have a chest x-ray.
- You will have CT scans or MRIs of the abdomen, pelvis. If the doctor thinks it is needed, you will also have a CT scan of the chest. If a CT scan of the chest is done, a chest x-ray is not required.
- You will have a bone scan.
If the study doctor thinks it is needed, you may have additional bone scans or CT scans or MRIs of the abdomen, pelvis, or chest to check the status of the disease.
Length of Study:
You may receive the study drug for up to 10 weeks. You will remain on study (receiving your standard hormone therapy) for up to a total of 22 weeks. You will be taken off study treatment if you have intolerable side effects, if the disease gets worse, or if you are unable to follow study directions. If you develop certain side effects or have certain side effects for a long period of time, you may be taken off study. The study doctor will let you know if you need to be taken off study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study To Determine T-cell Responses To Neoantigens Following Treatment With Ipilimumab In Men With Metastatic Castration-Resistant Prostate Carcinoma|
|Actual Study Start Date :||August 20, 2014|
|Actual Primary Completion Date :||November 4, 2019|
|Actual Study Completion Date :||November 4, 2019|
Ipilimumab administered by vein at a dose of 3 mg/kg once every 3 weeks for a total of 4 doses.
3 mg/kg by vein once every 3 weeks for a total of 4 doses.
- 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 ]T-cell response to neoantigens defined as: At least a 2-fold increase compared to the response seen against irrelevant control targets, and activating at least 0.1% of cells tested, or at least a 2-fold increase compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113657
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Padmanee Sharma, MD,PHD||M.D. Anderson Cancer Center|