Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

Prostate Oncology Specialists, Inc.

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer; Castrate Resistant Prostate Cancer

Treatments: Drug: ipilimumab; Drug: sipuleucel-T

Study type: Interventional

Funder types: Other

Identifiers

NCT01832870

SIPIPI 2013

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Drug: sipuleucel-T

Drug: ipilimumab