Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01057810
First received: January 26, 2010
Last updated: March 28, 2013
Last verified: November 2012
  Purpose

The purpose of this study is to determine if patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo


Condition Intervention Phase
Prostate Cancer
Drug: Ipilimumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare overall survival (OS) of subjects, defined as the time from the date of randomization until the date of death. For those subjects who have not died OS will be censored at the last date the subject was known to be alive [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks during follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare Progression Free Survival (PFS) by collecting tumor assessments every 12 weeks until protocol defined progression or initiation of subsequent therapy for prostate cancer [ Time Frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer ] [ Designated as safety issue: No ]
  • Compare time to pain progression by collection of a Patient Pain Diary prior to each treatment visit and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer [ Time Frame: each study visit while on treatment, and every 12 weeks during follow up until progression of disease or initiation of subsequent therapy for prostate cancer ] [ Designated as safety issue: No ]
  • Compare time to subsequent non-hormonal systemic therapy by collection of subsequent prostate cancer therapies during follow up [ Time Frame: Every 12 weeks during follow up until initiation of subequent non-hormonal systemic therapy for prostate cancer ] [ Designated as safety issue: No ]
  • Characterize Safety Profile by collection of adverse event information and review of laboratory values at every study visit [ Time Frame: Continuously throughout study and during follow up until all toxicities have resolved, returned to baseline or been deemed irreversible ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: July 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab Drug: Ipilimumab
5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Other Names:
  • BMS-734016
  • MDX010
Placebo Comparator: Placebo Drug: Placebo
Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until Treatment Stopping Criteria are met, withdrawal of consent, or study closure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic prostate cancer
  • Asymptomatic or minimally symptomatic
  • Progression during hormonal therapy
  • ECOG Performance Status 0-1

Exclusion Criteria:

  • Liver, lung or brain metastases
  • Prior immunotherapy or chemotherapy for metastatic prostate cancer
  • Autoimmune disease
  • HIV, Hepatitis B, or Hepatitis C infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057810

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Locations
United States, Alaska
Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States, 99508
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, California
Prostate Oncology Specialists, Inc.
Marina Del Rey, California, United States, 90292
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
Desert Hematology Oncology
Rancho Mirage, California, United States, 92270
Southern California Permanente Medical Group
San Diego, California, United States, 92108
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, United States, 33486
University Of Florida
Gainesville, Florida, United States, 32610
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Md Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Hematology Oncology Associates Of The Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Suburban Hematology-Oncology Associates, Pc
Lawrenceville, Georgia, United States, 30045
United States, Hawaii
Straub Clinic And Hospital
Honolulu, Hawaii, United States, 96813
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
Cancer Care Specialists Of Central Illinois
Decatur, Illinois, United States, 62526
Loyola University Chicago
Maywood, Illinois, United States, 60153
United States, Indiana
Iu Health Goshen Center For Cancer Care
Goshen, Indiana, United States, 46526
United States, Kansas
Hutchinson Clinic, Pa
Hutchinson, Kansas, United States, 67502
Colmery-O'Neil Va Medical Center
Topeka, Kansas, United States, 66622
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701
United States, Maine
Maine Center For Cancer Medicine
Scarborough, Maine, United States, 04074
United States, Maryland
University Of Maryland
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Batlimore, Maryland, United States, 21231
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Jersey
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Goshen Medical Associates
Goshen, New York, United States, 10924
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Syracuse Va Medical Center
Syracuse, New York, United States, 13210
Suny Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Timothy S. Collins, Md
Winston Salem, North Carolina, United States, 27103
United States, Oklahoma
Tulsa Cancer Institute, Pllc
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Oregon Health And Science University
Portland, Oregon, United States, 97239
Kaiser Permanente Oncology/Hematology
Portland, Oregon, United States, 97227
United States, Pennsylvania
St Luke'S Hospital And Health Network
Bethlehem, Pennsylvania, United States, 18015
United States, South Carolina
Cancer Centers Of The Carolinas
Greenville, South Carolina, United States, 29615
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Scott & White Memorial Hospital And Clinic
Temple, Texas, United States, 76508
United States, Washington
Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
Argentina
Local Institution
Rosario, Santa Fe, Argentina, S2000DSV
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Rosario, Santa Fe, Argentina, 2000
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Buenos Aires, Argentina, C1280AEB
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Buenos Aires, Argentina, 1120
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Buenos Aires, Argentina, C1426BOS
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Cordoba, Argentina, X5006HBF
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La Rioja, Argentina, 5300
Australia, New South Wales
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Kogarah, New South Wales, Australia, 2217
Australia, South Australia
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Ashford, South Australia, Australia, 5035
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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East Bentleigh, Victoria, Australia, 3165
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Frankston, Victoria, Australia, 3199
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Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
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Subiaco, Western Australia, Australia, 6008
Brazil
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Brasilia, Distrito Federal, Brazil, 72115
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Belo Horizonte, Minas Gerais, Brazil, 30150
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Belo Horizonte - Mg, Minas Gerais, Brazil, 31150
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Ijui, Rio Grande Do Sul, Brazil, 98700
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Porto Alegre, Rio Grande Do Sul, Brazil, 90430
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
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Montreal, Quebec, Canada, H2L 4M1
Canada
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Quebec, Canada, G1R 2J6
Chile
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Temuco, Araucania, Chile, 4810469
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Vina Del Mar, Valparaiso, Chile, 254 0364
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Santiago, Chile
Colombia
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Monteria, Cordoba, Colombia
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Bogota, Colombia
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Bucaramanga, Colombia
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Medellin, Colombia, MEDELLIN
Czech Republic
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Hradec Kralove, Czech Republic, 500 05
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Liberec, Czech Republic, 460 63
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Praha 5, Czech Republic, 150 30
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Praha 8, Czech Republic, 180 81
Denmark
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Herlev, Denmark, 2730
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Kobenhavn O, Denmark, 2100
France
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Bordeaux, France, 33075
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Clermont-Ferrand, France, 63000
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Marseille Cedex 9, France, 13273
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Pointe A Pitre, France, 97159
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Poitiers, France, 86000
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Villejuif Cedex, France, 94800
Germany
Local Institution
Aachen, Germany, 52074
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Heidelberg, Germany, 69120
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Marktredwitz, Germany, 95615
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Munich, Germany, 81675
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Wesel, Germany, 46483
Greece
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Athens, Greece, 115 28
Hungary
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Budapest, Hungary, 1064
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Budapest, Hungary, 1145
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Gyula, Hungary, 5700
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Szekesfehervar, Hungary, 8000
Italy
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Forli, Italy, 47100
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Milano, Italy, I-20132
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Siena, Italy, 53100
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Terni, Italy, 05100
Mexico
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Mexico, Distrito Federal, Mexico, 07760
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Mexico City, Distrito Federal, Mexico, 06726
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Tlalpan, Distrito Federal, Mexico, 14080
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Guadalajara, Jalisco, Mexico, 44280
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Zapopan, Jalisco, Mexico, 45150
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San Luis Potosi, Mexico, 78240
Netherlands
Local Institution
Amsterdam, Netherlands, 1081HV
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Sittard-Geleen, Netherlands, 6162 BG
Norway
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Kristiansand, Norway, 4604
Poland
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Gdansk, Poland, 80-402
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Krakow, Poland, 30-017
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Kutno, Poland, 99-300
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Lublin, Poland, 20-090
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Slupsk, Poland, 76-200
Puerto Rico
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San Juan, Puerto Rico, 00921
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San Juan, Puerto Rico, 00927
Romania
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Bucuresti, Romania, 022328
Spain
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Barcelona, Spain, 08036
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Barcelona, Spain, 08907
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Madrid, Spain, 28040
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Sevilla, Spain, 41071
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Valencia, Spain, 46009
Sweden
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Stockholm, Sweden, 171 76
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Uppsala, Sweden, 751 85
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Vaxjo, Sweden, 351 85
Turkey
Local Institution
Adana, Turkey, 01330
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Bornova, Izmir, Turkey, 35100
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Kocaeli, Turkey, 41400
United Kingdom
Local Institution
Glasgow, Lanarkshire, United Kingdom, G12 0YN
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Guildford, Surrey, United Kingdom, GU2 7WG
Local Institution
Birmingham, West Midlands, United Kingdom, B9 5SS
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01057810     History of Changes
Other Study ID Numbers: CA184-095, 2009-016217-23
Study First Received: January 26, 2010
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 14, 2014