Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

August 23, 2017 updated by: Prostate Oncology Specialists, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Marina del Rey, California, United States, 90292
        • Prostate Oncology Specialists, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.
Drug: ipilimumab
Other Names:
  • Yervoy
Drug: sipuleucel-T
Other Names:
  • Provenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 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
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

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
Time Frame: Duration of the study, an expected average of 18 months
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
Time Frame: Duration of the study, an expected average of 18 months
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
Time Frame: Duration of the study, an expected average of 18 months
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
Time Frame: Duration of the study, an expected average of 18 months
To measure percentage PSA decline following treatment with sipuleucel-T and ipilimumab
Duration of the study, an expected average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prostate Oncology Specialists, Inc.

Investigators

  • Principal Investigator: Mark Scholz, MD, Prostate Oncology Specialists, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIPIPI 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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