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


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Castrate Resistant Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antigen-specific memory T cell response

Outcome Description:

To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination.

Outcome Time Frame:

After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months

Safety Issue:

No

Principal Investigator

Mark Scholz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Prostate Oncology Specialists, Inc.

Authority:

United States: Institutional Review Board

Study ID:

SIPIPI 2013

NCT ID:

NCT01832870

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Castrate Resistant Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Prostate Oncology Specialists, Inc.Marina Del Rey, California  90292