Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

Study Overview
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Brief Summary
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This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer.

Official Title
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Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer

Conditions
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Prostate Cancer, Castrate Resistant Prostate Cancer

Intervention / Treatment
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* Drug: sipuleucel-T
* Drug: ipilimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with advanced prostate cancer who are eligible to receive sipuleucel-T in accordance with FDA approved labeling of sipuleucel-T Subjects must understand and sign an informed consent form Exclusion Criteria: Subjects who are not eligible to receive sipuleucel-T

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab. | Drug: sipuleucel-T<br> <br> * Other names: Provenge;Drug: ipilimumab<br> <br> * Other names: Yervoy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antigen-specific memory T cell response | To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination. | After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months | 
| Antigen-specific T cell proliferation to PA2024, PAP and PHA | To quantify Antigen-specific T cell proliferation to PA2024, PAP and PHA when sipuleucel-T and ipilimumab are given in combination. PA2024 is a recombinant protein PAP: Prostatic acid phosphatase PHA: Phytohaemagglutinin, an assay control | After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months | 
| Antibody responses against PA2024 and PAP | To quantify antibody responses against PA2024 and PAP. PA2024 is a recombinant protein PAP: Prostatic acid phosphatase | After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate-Specific Antigen (PSA) doubling time | To measure changes in PSA doubling time following treatment with sipuleucel-T and ipilimumab | Duration of the study, an expected average of 18 months | 
| Time to PSA progression | To quantify time to PSA progression after treatment with sipuleucel-T and ipilimumab | Duration of the study, an expected average of 18 months | 
| Time to salvage therapy | To quantify time to salvage therapy after treatment with sipuleucel-T and ipilimumab | Duration of the study, an expected average of 18 months | 
| Percentage PSA decline | To measure percentage PSA decline following treatment with sipuleucel-T and ipilimumab | Duration of the study, an expected average of 18 months |