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Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

Primary Purpose

Prostate Cancer, Castrate Resistant Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sipuleucel-T
ipilimumab
Sponsored by
Prostate Oncology Specialists, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Prostate Oncology Specialists, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Antigen-specific memory T cell response
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
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
To quantify antibody responses against PA2024 and PAP. PA2024 is a recombinant protein PAP: Prostatic acid phosphatase

Secondary Outcome Measures

Prostate-Specific Antigen (PSA) doubling time
To measure changes in PSA doubling time following treatment with sipuleucel-T and ipilimumab
Time to PSA progression
To quantify time to PSA progression after treatment with sipuleucel-T and ipilimumab
Time to salvage therapy
To quantify time to salvage therapy after treatment with sipuleucel-T and ipilimumab
Percentage PSA decline
To measure percentage PSA decline following treatment with sipuleucel-T and ipilimumab

Full Information

First Posted
April 10, 2013
Last Updated
August 23, 2017
Sponsor
Prostate Oncology Specialists, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01832870
Brief Title
Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer
Official Title
Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prostate Oncology Specialists, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Castrate Resistant Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.
Intervention Type
Drug
Intervention Name(s)
sipuleucel-T
Other Intervention Name(s)
Provenge
Intervention Type
Drug
Intervention Name(s)
ipilimumab
Other Intervention Name(s)
Yervoy
Primary Outcome Measure Information:
Title
Antigen-specific memory T cell response
Description
To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination.
Time Frame
After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
Title
Antigen-specific T cell proliferation to PA2024, PAP and PHA
Description
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
Time Frame
After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
Title
Antibody responses against PA2024 and PAP
Description
To quantify antibody responses against PA2024 and PAP. PA2024 is a recombinant protein PAP: Prostatic acid phosphatase
Time Frame
After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months
Secondary Outcome Measure Information:
Title
Prostate-Specific Antigen (PSA) doubling time
Description
To measure changes in PSA doubling time following treatment with sipuleucel-T and ipilimumab
Time Frame
Duration of the study, an expected average of 18 months
Title
Time to PSA progression
Description
To quantify time to PSA progression after treatment with sipuleucel-T and ipilimumab
Time Frame
Duration of the study, an expected average of 18 months
Title
Time to salvage therapy
Description
To quantify time to salvage therapy after treatment with sipuleucel-T and ipilimumab
Time Frame
Duration of the study, an expected average of 18 months
Title
Percentage PSA decline
Description
To measure percentage PSA decline following treatment with sipuleucel-T and ipilimumab
Time Frame
Duration of the study, an expected average of 18 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Scholz, MD
Organizational Affiliation
Prostate Oncology Specialists, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prostate Oncology Specialists, Inc.
City
Marina del Rey
State/Province
California
ZIP/Postal Code
90292
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

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