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NCT Number: NCT01832870

Sipuleucel-T and Ipilimumab 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.

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Key information

Conditions

Prostate Cancer Castrate Resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Prostate Oncology Specialists, Inc.

Marina del Rey, California, 90292, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sipuleucel-T

Drug

Other names: Provenge

Ipilimumab

Drug

Other names: Yervoy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Prostate Oncology Specialists, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2013
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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