Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

NCT ID: NCT01832870

Last Updated: 2017-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Prostate Cancer Castrate Resistant Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

sipuleucel-T

Intervention Type DRUG

ipilimumab

Intervention Type DRUG

Interventions

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sipuleucel-T

Intervention Type DRUG

ipilimumab

Intervention Type DRUG

Other Intervention Names

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Provenge Yervoy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Prostate Oncology Specialists, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Scholz, MD

Role: PRINCIPAL_INVESTIGATOR

Prostate Oncology Specialists, Inc.

Locations

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Prostate Oncology Specialists, Inc.

Marina del Rey, California, United States

Site Status

Countries

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United States

Other Identifiers

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SIPIPI 2013

Identifier Type: -

Identifier Source: org_study_id

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