NCT01832870

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

April 10, 2013

Last Update Submit

August 23, 2017

Conditions

Prostate CancerCastrate Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • Antigen-specific memory T cell response

    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

    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

    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 Outcomes (4)

  • Prostate-Specific Antigen (PSA) doubling time

    Duration of the study, an expected average of 18 months

  • Time to PSA progression

    Duration of the study, an expected average of 18 months

  • Time to salvage therapy

    Duration of the study, an expected average of 18 months

  • Percentage PSA decline

    Duration of the study, an expected average of 18 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: sipuleucel-TDrug: ipilimumab

Interventions

sipuleucel-TDRUG
Also known as: Provenge
Treatment
ipilimumabDRUG
Also known as: Yervoy
Treatment

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects who are not eligible to receive sipuleucel-T

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prostate Oncology Specialists, Inc.

Marina del Rey, California, 90292, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sipuleucel-TIpilimumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mark Scholz, MD

    Prostate Oncology Specialists, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 16, 2013

Study Start

April 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations

US(1)