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Trial record 1 of 2 for:    ipilimumab sipuleucel | Prostate Cancer
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Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE April 10, 2013
First Posted Date  ICMJE April 16, 2013
Last Update Posted Date August 24, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2013)
  • 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.
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2013)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer
Official Title  ICMJE Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Castrate Resistant Prostate Cancer
Intervention  ICMJE
  • Drug: sipuleucel-T
    Other Name: Provenge
  • Drug: ipilimumab
    Other Name: Yervoy
Study Arms  ICMJE Experimental: Treatment
Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab.
Interventions:
  • Drug: sipuleucel-T
  • Drug: ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2013)
9
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01832870
Other Study ID Numbers  ICMJE SIPIPI 2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prostate Oncology Specialists, Inc.
Study Sponsor  ICMJE Prostate Oncology Specialists, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Scholz, MD Prostate Oncology Specialists, Inc.
PRS Account Prostate Oncology Specialists, Inc.
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP