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NCT00861614

Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
NCT01057810
CompletedInterventionalPhase 3Updated Aug 18, 2016
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
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Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive
NCT02279862
CompletedInterventionalPhase 2Updated Aug 28, 2019
Neoadjuvant Ipilimumab in Prostate Cancer
NCT01194271
CompletedInterventionalPhase 2Updated Jun 6, 2024
T-Cell Responses to Neoantigens Post Treatment With Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer
NCT02113657
CompletedInterventionalEarly Phase 1Updated May 24, 2024
Ipilimumab + Androgen Depravation Therapy in Prostate Cancer
NCT01377389
TerminatedInterventionalPhase 2Updated Sep 29, 2023

Study of Immunotherapy to Treat Advanced Prostate Cancer | NCT00861614 | Trialant

CompletedInterventionalPhase 3Updated Sep 30, 2016

Study of Immunotherapy to Treat Advanced Prostate Cancer

A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel

ClinicalTrials.gov ID: NCT00861614
Lead Sponsor: Bristol-Myers SquibbINDUSTRY
Overall Status: Completed
Study Type: Interventional
Phase: Phase 3
Enrollment: 988Actual
Last Update Posted: Sep 30, 2016Estimated
Start Date: May 2009
Primary Completion Date: Nov 2012Actual
Completion Date: Aug 2015Actual

Official Title: A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel
Brief Summary: The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone

Prostate Cancer

Ipilimumab
Placebo

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Eligibility Criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Advanced prostate cancer

At least 1 bone metastasis

Testosterone < 50 ng/dl

Prior treatment with docetaxel

Exclusion Criteria:

Brain metastasis

Autoimmune disease

Known HIV, Hep B, or Hep C infection

More than 2 prior systemic anticancer regimens for prostate cancer

Prior treatment on BMS CA180227 for prostate cancer

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

No central contacts

There are no central contacts for this study.

Southern Cancer Center

Mobile, Alabama 36608, United States

Alaska Clinical Research Center, Llc

Anchorage, Alaska 99508, United States

Arizona Clinical Research Center, Inc.

Tucson, Arizona 85715, United States

Highlands Oncology Group, P.A.

Fayetteville, Arkansas 72703, United States

Marsha G. Fink, Md, Inc.

Fountain Valley, California 92708, United States

Loma Linda University Cancer Center

Loma Linda, California 92350, United States

Usc/Norris Comprehensive Cancer Center

Los Angeles, California 90033, United States

Prostate Oncology Specialists, Inc.

Marina del Rey, California 90292, United States

Comprehensive Cancer Center

Palm Springs, California 92262, United States

Va San Diego Healthcare System

San Diego, California 92161, United States

Pacific Hematology Oncology Associates

San Francisco, California 94115, United States

Baptist Cancer Institute

Jacksonville, Florida 32207, United States

Orlando Health, Inc

Orlando, Florida 32806, United States

Suburban Hematology-Oncology Associates, Pc

Lawrenceville, Georgia 30046, United States

University Of Chicago

Chicago, Illinois 60637, United States

Cancer Care Specialists Of Central Illinois

Decatur, Illinois 62526, United States

Edward Cancer Center

Naperville, Illinois 60540, United States

Mid-Illinois Hematology & Oncology Associates, Ltd

Normal, Illinois 61761, United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa 52242, United States

Siouxland Hematology-Oncology Assoc., Llp

Sioux City, Iowa 51101, United States

Hutchinson Clinic, Pa

Hutchinson, Kansas 67502, United States

Kentucky Cancer Clinic

Hazard, Kentucky 41701, United States

The Bunting-Blaustein Cancer Research Building

Baltimore, Maryland 21231, United States

Frederick Memorial Hospital Regional Cancer Therapy Center

Frederick, Maryland 21701, United States

Dana Farber Cancer Institute

Boston, Massachusetts 02115, United States

Mayo Clinic

Rochester, Minnesota 55905, United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri 64128, United States

St Johns Medical Research Institute, Inc.

Springfield, Missouri 65807, United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065, United States

Weill Cornell Medical College

New York, New York 10065, United States

Raleigh Hematology Oncology Associates

Raleigh, North Carolina 27607, United States

Gabrail Cancer Center

Canton, Ohio 44718, United States

University Of Cincinnati

Cincinnati, Ohio 45267, United States

Providence Portland Medical Center

Portland, Oregon 97213, United States

St. Luke'S Hospital & Health Network Laboratory

Bethlehem, Pennsylvania 18015, United States

Va Pittsburgh Healthcare System

Pittsburgh, Pennsylvania 15240, United States

Associates In Hematology & Oncology, P.C.

Upland, Pennsylvania 19013, United States

Musc Hollings Cancer Center

Charleston, South Carolina 29445, United States

Center For Oncology Research & Treatment, P.A.

Dallas, Texas 75230, United States

The Center For Cancer And Blood Disorders

Fort Worth, Texas 76104, United States

The University Of Texas Md Anderson Cancer Center

Houston, Texas 77030, United States

Northwest Cancer Center

Houston, Texas 77090, United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112, United States

Edwards Comprehensive Cancer Center

Huntington, West Virginia 25701, United States

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Odense C, 5000, Denmark

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Amsterdam, 1066 CX, Netherlands

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Lima, Lima Province 18, Peru

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Romania, 400015, Romania

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Suceava, 720237, Romania

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Manchester, Greater Manchester M20 4BX, United Kingdom

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Scunthorpe, Lincolnshire DN15 7BH, United Kingdom

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Nottingham, Nottinghamshire NG5 1PB, United Kingdom

Lead Sponsor: Bristol-Myers SquibbINDUSTRY