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

Last updated: August 14, 2019
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

2

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT02279862
CA184-437
2014-002987-34
  • Ages > 18
  • Male

Study Summary

The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

Eligibility Criteria

Inclusion

For more information regarding BMS clinical trial participation, please visitwww.BMSStudyConnect.com Inclusion Criteria:

  • Prostate cancer with metastases

  • Prostate cancer should be castration resistant

  • Progression during hormonal therapy

Exclusion

Exclusion Criteria:

  • Visceral metastases (eg liver, lung or brain metastases)

  • Prior treatment with any immunotherapy for prostate cancer

  • Prior or ongoing cytotoxic therapy for prostate cancer

  • Autoimmune disease

  • Inadequate hematologic, renal, or hepatic function

Study Design

Total Participants: 82
Study Start date:
December 02, 2014
Estimated Completion Date:
December 15, 2016

Study Description

Prostate Cancer Clinical Trials Working Group 2 (PCWG2)

Response Evaluation Criteria In Solid Tumors (RECIST)

Connect with a study center

  • Local Institution

    Berazategui, Buenos Aires 1880
    Argentina

    Site Not Available

  • Local Institution

    Quilmes, Buenos Aires 1878
    Argentina

    Site Not Available

  • Local Institution

    San Miguel De Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • Local Institution

    Buenos Aires, 1180AAX
    Argentina

    Site Not Available

  • Local Institution

    Cordoba, 5000
    Argentina

    Site Not Available

  • Local Institution

    La Rioja, 5300
    Argentina

    Site Not Available

  • Local Institution

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Local Institution

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Local Institution

    Wahroonga, New South Wales 2076
    Australia

    Site Not Available

  • Local Institution

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Local Institution

    Perth, Western Australia 6150
    Australia

    Site Not Available

  • Local Institution

    Santiago, Metropolitana
    Chile

    Site Not Available

  • Local Institution

    Recoleta, Santiago DE Chile
    Chile

    Site Not Available

  • Local Institution

    Vina Del Mar, Valparaiso 2540364
    Chile

    Site Not Available

  • Local Institution

    Cali, Valle Del Cauca
    Colombia

    Site Not Available

  • Local Institution

    Bogota,
    Colombia

    Site Not Available

  • Local Institution

    Medellin, MEDELLIN
    Colombia

    Site Not Available

  • Local Institution

    Clermont Ferrand cedex 01, 63011
    France

    Site Not Available

  • Local Institution

    Clermont-ferrand, 63000
    France

    Site Not Available

  • Local Institution

    Marseille Cedex 9, 13273
    France

    Site Not Available

  • Local Institution

    Poitiers,
    France

    Site Not Available

  • Local Institution

    Rennes Cedex, 35042
    France

    Site Not Available

  • Local Institution

    Saint Herblain, 44805
    France

    Site Not Available

  • Local Institution

    Villejuif, 94805
    France

    Site Not Available

  • Universitaetsklinikum Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Charite-Universitaetsmedizin Berlin

    Berlin, 12200
    Germany

    Site Not Available

  • Uniklinik Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitaetsklinikum Des Saarlandes

    Homburg, 66424
    Germany

    Site Not Available

  • Universitaetsklinikum Jena

    Jena, 07743
    Germany

    Site Not Available

  • Universitaetsklinikum Magdeburg

    Magdeburg, 39120
    Germany

    Site Not Available

  • Universitaetsklinikum Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

  • Local Institution

    Marktredwitz, 95615
    Germany

    Site Not Available

  • Klinikum rechts der Isar der TU

    Muenchen, 81675
    Germany

    Site Not Available

  • Urologische Praxis

    Rostock, 18107
    Germany

    Site Not Available

  • Urologische Gemeinschaftspraxis Dres Stammel U. Garcia

    Wesel, 46483
    Germany

    Site Not Available

  • Dgu Urologie

    Wuppertal, 42103
    Germany

    Site Not Available

  • Local Institution

    Arezzo, 52100
    Italy

    Site Not Available

  • Local Institution

    Forli - Cesena, 47014
    Italy

    Site Not Available

  • Local Institution

    Milano, 20133
    Italy

    Site Not Available

  • Istituto Nazionale Tumori Fondazione Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Local Institution

    Siena, 53100
    Italy

    Site Not Available

  • Local Institution

    Torino, 10060
    Italy

    Site Not Available

  • Local Institution

    Tlalpan, Distrito Federal 14080
    Mexico

    Site Not Available

  • Local Institution

    Guadalajara, Jal., Jalisco 44280
    Mexico

    Site Not Available

  • Local Institution

    Zapopan, Jalisco 45150
    Mexico

    Site Not Available

  • Local Institution

    Monterrey, N.l., Nuevo Leon 64460
    Mexico

    Site Not Available

  • Local Institution

    Aguascalientes, 20230
    Mexico

    Site Not Available

  • Local Institution

    Mexico, 11560
    Mexico

    Site Not Available

  • Local Institution

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Local Institution

    Sittard-geleen, 6162 BG
    Netherlands

    Site Not Available

  • Local Institution

    Utrecht, 6500 HB
    Netherlands

    Site Not Available

  • Local Institution

    Barcelona, 08035
    Spain

    Site Not Available

  • Local Institution

    Hospitalet Llobregat- Barcelona, 9908
    Spain

    Site Not Available

  • Local Institution

    Hospitalet de Llobregat - Barcelona, 08908
    Spain

    Site Not Available

  • Local Institution

    Madrid, 28050
    Spain

    Site Not Available

  • Local Institution

    Sevilla, 41009
    Spain

    Site Not Available

  • Local Institution

    Valencia, 46009
    Spain

    Site Not Available

  • Local Institution

    Glasgow, Lanarkshire G12 0YN
    United Kingdom

    Site Not Available

  • Local Institution

    Scunthorpe, Lincolnshire DN15 7BH
    United Kingdom

    Site Not Available

  • Local Institution

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • Local Institution

    Guildford, Surrey GU2 7XX
    United Kingdom

    Site Not Available

  • San Francisco Oncology Associates

    San Francisco, California 94115
    United States

    Site Not Available

  • George Washington University Medical Center

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • George Washington University Medical Faculty Associates

    Washington, D.C., District of Columbia 20037
    United States

    Site Not Available

  • Baptist Cancer Institute

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Cancer Center Of Kansas

    Wichita, Kansas 67214
    United States

    Site Not Available

  • North Mississippi Med Center

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • Northwest Cancer Specialists, Pc

    Tualatin, Oregon 97062
    United States

    Site Not Available

  • University of Pittsburgh Cancer Institute Cancer Services

    Pittsburgh, Pennsylvania 15232-1305
    United States

    Site Not Available

  • Local Institution

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Oncology

    Houston, Texas 77024
    United States

    Site Not Available

  • Local Institution

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Virginia Cancer Institute

    Richmond, Virginia 23230
    United States

    Site Not Available

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