Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
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
2 other identifiers
interventional
837
24 countries
134
Brief Summary
The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Jul 2010
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
August 18, 2016
CompletedAugust 18, 2016
July 1, 2016
4.8 years
January 26, 2010
March 7, 2016
July 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) Time
OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.
Randomization until death from any cause, up to April 2015, approximately 57 months
Secondary Outcomes (5)
Progression-Free Survival (PFS) Time
Randomization until disease progression, up to April 2015, approximately 57 months
Time to Subsequent Non-hormonal Cytotoxic Therapy
Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months
Time to Pain Progression
Randomization until pain progression, up to April 2015, approximately 57 months
Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)
Day 1 of study therapy to last dose plus 70 days
Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities
Randomization up to April 2015, approximately 57 months
Study Arms (2)
Ipilimumab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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 total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
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 total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Eligibility Criteria
You may qualify if:
- Metastatic prostate cancer
- Asymptomatic or minimally symptomatic
- Progression during hormonal therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
You may not qualify if:
- Liver, lung or brain metastases
- Prior immunotherapy or chemotherapy for metastatic prostate cancer
- Autoimmune disease
- HIV, Hepatitis B, or Hepatitis C infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
Alaska Clinical Research Center, Llc
Anchorage, Alaska, 99508, United States
Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Desert Hematology Oncology
Rancho Mirage, California, 92270, United States
Southern California Permanente Medical Group
San Diego, California, 92108, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, 33486, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Hematology Oncology Associates Of The Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Northside Hospital
Atlanta, Georgia, 30341, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, 30046, United States
Straub Clinic And Hospital
Honolulu, Hawaii, 96813, United States
University Of Chicago
Chicago, Illinois, 60637, United States
Cancer Care Specialists Of Central Illinois
Decatur, Illinois, 62526, United States
Goshen Center For Cancer Care
Goshen, Indiana, 46526, United States
Hutchinson Clinic, Pa
Hutchinson, Kansas, 67502, United States
Cancer Center Of Kansas
Wichita, Kansas, 67214, United States
University Of Maryland
Baltimore, Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, 89148, United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733, United States
Goshen Medical Associates
Goshen, New York, 10924, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Suny Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, 74136, United States
Kaiser Permanente Oncology/Hematology
Portland, Oregon, 97227, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
St. Luke'S Hospital & Health Network Laboratory
Bethlehem, Pennsylvania, 18015, United States
Cancer Center Of The Carolinas
Greenville, South Carolina, 29615, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Scott & White Memorial Hospital And Clinic
Temple, Texas, 76508, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Local Institution
Buenos Aires, Buenos Aires, 1120, Argentina
Local Institution
Buenos Aires, Buenos Aires, C1280AEB, Argentina
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Buenos Aires, Buenos Aires, C1426BOS, Argentina
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Córdoba, Córdoba Province, X5006HBF, Argentina
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La Rioja, La Rioja Province, 5300, Argentina
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Rosario, Santa Fe Province, S2000DSK, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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Kogarah, New South Wales, 2217, Australia
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Ashford, South Australia, 5035, Australia
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Box Hill, Victoria, 3128, Australia
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East Bentleigh, Victoria, 3165, Australia
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Frankston, Victoria, 3199, Australia
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Heidelberg, Victoria, 3084, Australia
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Subiaco, Western Australia, 6008, Australia
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Brasília, Federal District, 72115, Brazil
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Belo Horizonte, Minas Gerais, 30150, Brazil
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Belo Horizonte - Mg, Minas Gerais, 31150, Brazil
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Ijuí, Rio Grande do Sul, 98700, Brazil
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Porto Alegre, Rio Grande do Sul, 90430, Brazil
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Kingston, Ontario, K7L 2V7, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Québec, Quebec, G1R 2J6, Canada
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Temuco, Región de la Araucanía, 4810469, Chile
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Viña del Mar, Región de Valparaíso, 2540364, Chile
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Santiago, Chile
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Montería, Departamento de Córdoba, Colombia
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Bogotá, Colombia
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Bucaramanga, Colombia
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Medellín, MEDELLIN, Colombia
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Hradec Králové, 500 05, Czechia
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Liberec, 460 63, Czechia
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Prague, 150 30, Czechia
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Prague, 180 81, Czechia
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Herlev, 2730, Denmark
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København Ø, 2100, Denmark
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Bordeaux, 33075, France
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Clermont-Ferrand, 63000, France
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Marseille, 13273, France
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Pointe à Pitre, 97159, France
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Poitiers, 86000, France
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Villejuif, 94805, France
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Aachen, 52074, Germany
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Heidelberg, 69120, Germany
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Marktredwitz, 95615, Germany
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Munich, 81675, Germany
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Wesel, 46483, Germany
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Athens, 115 28, Greece
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Budapest, 1064, Hungary
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Budapest, 1145, Hungary
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Gyula, 5700, Hungary
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Székesfehérvár, H-8000, Hungary
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Meldola (FC), 47014, Italy
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Milan, I-20132, Italy
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Siena, 53100, Italy
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Terni, 05100, Italy
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Guadalajara, Jalisco, 44280, Mexico
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Zapopan, Jalisco, 45150, Mexico
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Mexico City, Mexico City, 06726, Mexico
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Mexico City, Mexico City, 07760, Mexico
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Tlalpan, Mexico City, 14080, Mexico
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México, Querétaro, 76200, Mexico
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San Luis Potosí City, San Luis Potosí, 78240, Mexico
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Amsterdam, 1081HV, Netherlands
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Sittard-geleen, 6162 BG, Netherlands
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Kristiansand, 4604, Norway
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Gdansk, 80-402, Poland
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Kościerzyna, 83-400, Poland
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Krakow, 30-017, Poland
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Kutno, 99-300, Poland
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Lublin, 20-090, Poland
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Poznan, 60-693, Poland
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Słupsk, 76-200, Poland
Va Caribbean Healthcare System
San Juan, 00921, Puerto Rico
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Bucharest, 022328, Romania
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Cluj-napoca, Cluj County, 400046, Romania
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Timisoara,timis County, 300376, Romania
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Barcelona, 08036, Spain
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Barcelona, 08907, Spain
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Madrid, 28040, Spain
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Seville, 41071, Spain
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Valencia, 46009, Spain
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Stockholm, 171 76, Sweden
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Uppsala, 751 85, Sweden
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Vaxjo, 351 85, Sweden
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Adana, 01330, Turkey (Türkiye)
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Bornova, Izmir, 35100, Turkey (Türkiye)
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Gaziantep, 27310, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Kocaeli, 41400, Turkey (Türkiye)
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Glasgow, Lanarkshire, G12 0YN, United Kingdom
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Guildford, Surrey, GU2 7WG, United Kingdom
Local Institution
Birmingham, West Midlands, B9 5SS, United Kingdom
Related Publications (2)
de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
PMID: 24722180DERIVEDDayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13.
PMID: 21917607DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2015
Study Completion
July 1, 2015
Last Updated
August 18, 2016
Results First Posted
August 18, 2016
Record last verified: 2016-07