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Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01832870
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Castrate Resistant Prostate Cancer Drug: sipuleucel-T Drug: ipilimumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer
Study Start Date : April 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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

Drug: ipilimumab
Other Name: Yervoy




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832870


Locations
United States, California
Prostate Oncology Specialists, Inc.
Marina del Rey, California, United States, 90292
Sponsors and Collaborators
Prostate Oncology Specialists, Inc.
Investigators
Principal Investigator: Mark Scholz, MD Prostate Oncology Specialists, Inc.

Responsible Party: Prostate Oncology Specialists, Inc.
ClinicalTrials.gov Identifier: NCT01832870     History of Changes
Other Study ID Numbers: SIPIPI 2013
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs