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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sipuleucel-T | Drug |
|
| |
| ipilimumab |
| 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.
| 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.
| After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Scholz, MD | Prostate Oncology Specialists, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prostate Oncology Specialists, Inc. | Marina del Rey | California | 90292 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C511774 | sipuleucel-T |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
|
|
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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |