Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

Phase 1

Completed

• Conditions: Castrate Resistant Prostate Cancer; Prostate Cancer
• Interventions: Drug: sipuleucel-T; Drug: ipilimumab

• Registration Number: NCT01832870
• Lead Sponsor: Prostate Oncology Specialists, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-16
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-23
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	ipilimumab	Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.
Treatment	sipuleucel-T	Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.

Primary Outcome Measures

Name	Time	Method
Antigen-specific memory T cell response	After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months	To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination.
Antigen-specific T cell proliferation to PA2024, PAP and PHA	After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months	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
Antibody responses against PA2024 and PAP	After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months	To quantify antibody responses against PA2024 and PAP.; * PA2024 is a recombinant protein; * PAP: Prostatic acid phosphatase

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prostate Oncology Specialists, Inc.; 🇺🇸 Marina del Rey, California, United States