Overview

This trial is active, not recruiting.

Conditions prostate cancer, castrate resistant prostate cancer
Treatments sipuleucel-t, ipilimumab
Phase phase 1
Target CTLA-4
Sponsor Prostate Oncology Specialists, Inc.
Start date April 2013
End date February 2016
Trial size 9 participants
Trial identifier NCT01832870, SIPIPI 2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.
sipuleucel-t Provenge
ipilimumab Yervoy

Primary Outcomes

Measure
Antigen-specific memory T cell response
time frame: 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
time frame: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
Antibody responses against PA2024 and PAP
time frame: After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months

Secondary Outcomes

Measure
Prostate-Specific Antigen (PSA) doubling time
time frame: Duration of the study, an expected average of 18 months
Time to PSA progression
time frame: Duration of the study, an expected average of 18 months
Time to salvage therapy
time frame: Duration of the study, an expected average of 18 months
Percentage PSA decline
time frame: Duration of the study, an expected average of 18 months

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer
Principal investigator Mark Scholz, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Prostate Oncology Specialists, Inc..