Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00861614




Registration number
NCT00861614
Ethics application status
Date submitted
12/03/2009
Date registered
13/03/2009
Date last updated
30/09/2016

Titles & IDs
Public title
Study of Immunotherapy to Treat Advanced Prostate Cancer
Scientific 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
Secondary ID [1] 0 0
2008-003314-97
Secondary ID [2] 0 0
CA184-043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Placebo

Active comparator: Ipilimumab -

Placebo comparator: Placebo -


Treatment: Drugs: 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure

Treatment: Drugs: 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Date of randomization to date of death
Primary outcome [2] 0 0
Overall Survival Rate
Timepoint [2] 0 0
Date of randomization to date of death
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death
Secondary outcome [2] 0 0
Pain Response
Timepoint [2] 0 0
Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit
Secondary outcome [3] 0 0
Duration of Pain Response
Timepoint [3] 0 0
Day of initial pain response to day of completion of pain response or date of death
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Randomization to date of death
Secondary outcome [5] 0 0
Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)
Timepoint [5] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [6] 0 0
Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)
Timepoint [6] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [7] 0 0
Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)
Timepoint [7] 0 0
Day 1 to time of onset of the imAR of interest
Secondary outcome [8] 0 0
Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0
Timepoint [8] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [9] 0 0
Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline
Timepoint [9] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [10] 0 0
Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline
Timepoint [10] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [11] 0 0
Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline
Timepoint [11] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [12] 0 0
Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline
Timepoint [12] 0 0
Day 1 to 70 days after last dose of study drug

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.



* Advanced prostate cancer
* At least 1 bone metastasis
* Testosterone < 50 ng/dl
* Prior treatment with docetaxel
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
988
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Box Hill
Recruitment hospital [2] 0 0
Local Institution - Frankston
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - Subiaco
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
West Virginia
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Argentina
State/province [27] 0 0
Tucuman
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordoba
Country [29] 0 0
Argentina
State/province [29] 0 0
La Rioja
Country [30] 0 0
Austria
State/province [30] 0 0
Salzburg
Country [31] 0 0
Austria
State/province [31] 0 0
Wien
Country [32] 0 0
Belgium
State/province [32] 0 0
Brussels
Country [33] 0 0
Belgium
State/province [33] 0 0
Bruxelles
Country [34] 0 0
Belgium
State/province [34] 0 0
Roeselare
Country [35] 0 0
Brazil
State/province [35] 0 0
Ceara
Country [36] 0 0
Brazil
State/province [36] 0 0
Parana
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio Grande Do Sul
Country [38] 0 0
Brazil
State/province [38] 0 0
Sao Paulo
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Chile
State/province [40] 0 0
Araucania
Country [41] 0 0
Chile
State/province [41] 0 0
Metropolitana
Country [42] 0 0
Chile
State/province [42] 0 0
Valparaiso
Country [43] 0 0
Colombia
State/province [43] 0 0
Cordoba
Country [44] 0 0
Colombia
State/province [44] 0 0
Bogota
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Brno
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Liberec
Country [48] 0 0
Denmark
State/province [48] 0 0
Aalborg
Country [49] 0 0
Denmark
State/province [49] 0 0
Aarhus
Country [50] 0 0
Denmark
State/province [50] 0 0
Herlev
Country [51] 0 0
Denmark
State/province [51] 0 0
Kobenhavn O
Country [52] 0 0
Denmark
State/province [52] 0 0
Odense C
Country [53] 0 0
France
State/province [53] 0 0
Besancon Cedex
Country [54] 0 0
France
State/province [54] 0 0
Bordeaux
Country [55] 0 0
France
State/province [55] 0 0
Clermont-ferrand
Country [56] 0 0
France
State/province [56] 0 0
Marseille Cedex 20
Country [57] 0 0
France
State/province [57] 0 0
Pointe A Pitre
Country [58] 0 0
France
State/province [58] 0 0
Villejuif Cedex
Country [59] 0 0
Germany
State/province [59] 0 0
Berlin
Country [60] 0 0
Germany
State/province [60] 0 0
Bonn
Country [61] 0 0
Germany
State/province [61] 0 0
Eschweiler
Country [62] 0 0
Germany
State/province [62] 0 0
Mannheim
Country [63] 0 0
Germany
State/province [63] 0 0
Wuppertal
Country [64] 0 0
Greece
State/province [64] 0 0
Athens
Country [65] 0 0
Hungary
State/province [65] 0 0
Budapest
Country [66] 0 0
Hungary
State/province [66] 0 0
Gyula
Country [67] 0 0
Hungary
State/province [67] 0 0
Kaposvar
Country [68] 0 0
Hungary
State/province [68] 0 0
Kecskemet
Country [69] 0 0
Ireland
State/province [69] 0 0
Dublin
Country [70] 0 0
Israel
State/province [70] 0 0
Beer Jacob
Country [71] 0 0
Israel
State/province [71] 0 0
Beer-sheva
Country [72] 0 0
Israel
State/province [72] 0 0
Haifa
Country [73] 0 0
Israel
State/province [73] 0 0
Tel Aviv
Country [74] 0 0
Israel
State/province [74] 0 0
Tel Hashomer
Country [75] 0 0
Italy
State/province [75] 0 0
Meldola (fc)
Country [76] 0 0
Italy
State/province [76] 0 0
Milano
Country [77] 0 0
Italy
State/province [77] 0 0
Napoli
Country [78] 0 0
Italy
State/province [78] 0 0
Rimini
Country [79] 0 0
Italy
State/province [79] 0 0
Siena
Country [80] 0 0
Italy
State/province [80] 0 0
Sondrio
Country [81] 0 0
Mexico
State/province [81] 0 0
Distrito Federal
Country [82] 0 0
Mexico
State/province [82] 0 0
Guerrero
Country [83] 0 0
Mexico
State/province [83] 0 0
Jalisco
Country [84] 0 0
Mexico
State/province [84] 0 0
Morelos
Country [85] 0 0
Mexico
State/province [85] 0 0
Aguascalientes
Country [86] 0 0
Mexico
State/province [86] 0 0
Puebla
Country [87] 0 0
Netherlands
State/province [87] 0 0
Amsterdam
Country [88] 0 0
Netherlands
State/province [88] 0 0
Mb Amsterdam
Country [89] 0 0
Peru
State/province [89] 0 0
Arequipa
Country [90] 0 0
Peru
State/province [90] 0 0
Lima
Country [91] 0 0
Poland
State/province [91] 0 0
Olsztyn
Country [92] 0 0
Puerto Rico
State/province [92] 0 0
Ponce
Country [93] 0 0
Romania
State/province [93] 0 0
Bucharest
Country [94] 0 0
Romania
State/province [94] 0 0
Romania
Country [95] 0 0
Romania
State/province [95] 0 0
Suceava
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Moscow
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Obninsk
Country [98] 0 0
Russian Federation
State/province [98] 0 0
St Petersburg
Country [99] 0 0
Spain
State/province [99] 0 0
Barcelona
Country [100] 0 0
Spain
State/province [100] 0 0
Benidorm-alicante
Country [101] 0 0
Spain
State/province [101] 0 0
Madrid
Country [102] 0 0
Spain
State/province [102] 0 0
Santiago De Compostela
Country [103] 0 0
Spain
State/province [103] 0 0
Valencia
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Essex
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Glamorgan
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Greater Manchester
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Lincolnshire
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Nottinghamshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00861614
Trial related presentations / publications
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: [email protected]; 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.
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. 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.
Dayyani 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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00861614