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
2 other identifiers
interventional
988
26 countries
154
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
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 May 2009
Typical duration for phase_3 prostate-cancer
154 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
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
March 16, 2016
CompletedSeptember 30, 2016
August 1, 2016
3.5 years
March 12, 2009
March 15, 2016
August 4, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS)
OS is defined as the time in months from randomization date to date of death due to any cause in all randomized subjects. For participants alive at the time of the database cutoff date, OS was censored at the last date the participant was known to be alive.
Date of randomization to date of death
Overall Survival Rate
The overall survival (OS) rate is a percentage, representing the fraction of all randomized participants who were alive following treatment, from 1 to 5 years. OS was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
Date of randomization to date of death
Secondary Outcomes (12)
Progression Free Survival (PFS)
Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death
Pain Response
Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit
Duration of Pain Response
Day of initial pain response to day of completion of pain response or date of death
Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE) and Immune-Mediated Adverse Reaction (imAR)
Randomization to date of death
Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)
Day 1 to 70 days after last dose of study drug
- +7 more secondary outcomes
Study Arms (2)
Ipilimumab
ACTIVE COMPARATORPlacebo
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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
Eligibility Criteria
You may qualify if:
- Advanced prostate cancer
- At least 1 bone metastasis
- Testosterone \< 50 ng/dl
- Prior treatment with docetaxel
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (158)
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
Local Institution
Buenos Aires, Buenos Aires, 1019, Argentina
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Buenos Aires, Buenos Aires, 1120, Argentina
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Buenos Aires, Buenos Aires, C1280AEB, Argentina
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Buenos Aires, Buenos Aires, C1426ANZ, Argentina
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Caba, Buenos Aires, 1417, Argentina
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Capital Federal, Buenos Aires, 1426, Argentina
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Córdoba, Córdoba Province, X5002AOQ, 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, 2000, Argentina
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Rosario, Santa Fe Province, S2000DSK, Argentina
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San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina
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Box Hill, Victoria, 3128, 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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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Brussels, 1000, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Roeselare, 8800, Belgium
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Fortaleza, Ceará, 60430, Brazil
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Curitiba, Paraná, 80440, Brazil
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Ijuí, Rio Grande do Sul, 98700000, Brazil
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Porto Alegre, Rio Grande do Sul, 90430, Brazil
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Porto Alegre, Rio Grande do Sul, 90610, Brazil
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Curitiba, São Paulo, 80530, Brazil
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Divinopolis, São Paulo, 35500, Brazil
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Mogi das Cruzes, São Paulo, 08730, Brazil
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São Paulo, São Paulo, 05403, Brazil
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São Paulo, São Paulo, 09060, Brazil
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Temuco, Región de la Araucanía, Chile
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Vi?a Del Mar, Región de Valparaíso, Chile
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Santiago, Santiago Metropolitan, 7510032, Chile
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Santiago, Santiago Metropolitan, 7650635, Chile
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Santiago - Independencia, Santiago Metropolitan, Chile
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Montería, Departamento de Córdoba, Colombia
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Bogotá, Colombia
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Brno, 656 91, Czechia
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Hradec Králové, 500 05, Czechia
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Liberec, 460 63, Czechia
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Aalborg, 9000, Denmark
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Aarhus, 8000, Denmark
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Herlev, 2730, Denmark
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København Ø, 2100, Denmark
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Odense C, 5000, Denmark
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Besançon, 25030, France
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Bordeaux, 33076, France
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Clermont-Ferrand, 63000, France
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Marseille, 13915, France
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Pointe à Pitre, 97159, France
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Villejuif, 94800, France
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Berlin, 14197, Germany
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Bonn, 53127, Germany
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Eschweiler, 52249, Germany
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Mannheim, 68167, Germany
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Wuppertal, 42103, Germany
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Athens, 115 28, Greece
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Budapest, 1122, Hungary
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Gyula, 5700, Hungary
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Kaposvár, 7400, Hungary
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Kecskemét, 6000, Hungary
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Dublin, Dublin, Ireland
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Tallaght, Dublin, DUBLIN 24, Ireland
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Beer Jacob, 70300, Israel
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Beersheba, 84101, Israel
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Haifa, 31096, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Meldola (fc), 47014, Italy
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Milan, 20132, Italy
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Napoli, 80131, Italy
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Rimini, 47900, Italy
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Siena, 53100, Italy
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Sondrio, 23100, Italy
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Aguascalientes, Aguascalientes, 20234, Mexico
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Acapulco de Juárez, Guerrero, 39570, Mexico
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Guadalajara, Jalisco, Mexico
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Df, Mexico City, 06720, Mexico
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Mexico City, Mexico City, 07760, Mexico
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Cuernavaca, Morelos, 62290, Mexico
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Puebla City, Puebla, 72270, Mexico
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Amsterdam, 1066 CX, Netherlands
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Mb Amsterdam, 1007MB, Netherlands
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Lima, Lima Province, 18, Peru
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Lima, Lima Province, 34, Peru
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Lima, Lima Province, L-27, Peru
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Lima, Lima Province, LIMA 11, Peru
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Arequipa, AREQUIPA54, Peru
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Olsztyn, 10-228, Poland
Ponce School Of Medicine
Ponce, 00716, Puerto Rico
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Bucharest, 011172, Romania
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Romania, 400015, Romania
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Suceava, 720237, Romania
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Moscow, 129128, Russia
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Obninsk, 249036, Russia
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Saint Petersburg, 197758, Russia
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Barcelona, 08035, Spain
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Barcelona, 08208, Spain
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Benidorm-alicante, 03501, Spain
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Madrid, 28922, Spain
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Santiago de Compostela, 157706, Spain
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Valencia, 46009, Spain
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Chelmsford, Essex, CM1 7ET, United Kingdom
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Cardiff, Glamorgan, CF14 2TL, United Kingdom
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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
Related Publications (3)
Trump D. Commentary on: "Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): A multicentre, randomised, double-blind, phase 3 trial." Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengelov L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR, CA184-043 Investigators. Departments of Urology and Immunology and Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Rochester, MN, USA, Electronic address: kwon.eugene@mayo.edu; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and Brady Urological Institute, Baltimore, MD, USA; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA; Institut Gustave Roussy, University of Paris-Sud, Villejuif, France; Institut Gustave Roussy, Villejuif, France; VU University Medical Centre, Amsterdam, Netherlands; Vienna General Hospital, Medical University Vienna, Vienna, Austria; Institut Bergonie, Bordeaux, France; CHU Caremeau, Nimes, France; Centro Medico Austral, Buenos Aires, Argentina; Centre Jean Perrin, Clermont-Ferrand, France; St John of God Hospital, Subiaco, WA, Australia; University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy; Hospital de Caridade de Ijui, Ijui, Brazil; Nottingham University Hospital, Nottingham, UK; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA; Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands; Institute of Oncology Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania; Hospital Britanico de Buenos Aires, Buenos Aires, Argentina; Herlev Hospital, Herlev, Denmark; Odense University Hospital, Odense, Denmark; University of Texas MD Anderson Cancer Center, Houston, Urol Oncol. 2016 May;34(5):249-50. doi: 10.1016/j.urolonc.2015.03.013. Epub 2015 Apr 20.
PMID: 25907621DERIVEDKwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengelov L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR; CA184-043 Investigators. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):700-12. doi: 10.1016/S1470-2045(14)70189-5. Epub 2014 May 13.
PMID: 24831977DERIVEDDayyani 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
- LTE60
- 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
March 12, 2009
First Posted
March 13, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2012
Study Completion
August 1, 2015
Last Updated
September 30, 2016
Results First Posted
March 16, 2016
Record last verified: 2016-08