Clinical trial NCT00861614: Study of Immunotherapy to Treat Advanced Prostate Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 988
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Inclusion Criteria:

* Advanced prostate cancer
* At least 1 bone metastasis
* Testosterone \< 50 ng/dl
* Prior treatment with docetaxel

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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Date of randomization to date of death
measure: Overall Survival Rate
timeFrame: Date of randomization to date of death
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death
measure: Pain Response
timeFrame: Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit
measure: Duration of Pain Response
timeFrame: Day of initial pain response to day of completion of pain response or date of death
measure: 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)
timeFrame: Randomization to date of death
measure: Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)
timeFrame: Day 1 to 70 days after last dose of study drug
measure: Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)
timeFrame: Day 1 to 70 days after last dose of study drug
measure: Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)
timeFrame: Day 1 to time of onset of the imAR of interest
measure: Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0
timeFrame: Day 1 to 70 days after last dose of study drug
measure: Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline
timeFrame: Day 1 to 70 days after last dose of study drug
measure: Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline
timeFrame: Day 1 to 70 days after last dose of study drug
measure: Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline
timeFrame: Day 1 to 70 days after last dose of study drug
measure: Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline
timeFrame: Day 1 to 70 days after last dose of study drug
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, Llc
state: Alaska
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group, P.A.
state: Arkansas
city: Fountain Valley
country: United States
facility: Marsha G. Fink, Md, Inc.
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
city: Los Angeles
country: United States
facility: Usc/Norris Comprehensive Cancer Center
state: California
city: Marina Del Rey
country: United States
facility: Prostate Oncology Specialists, Inc.
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: Va San Diego Healthcare System
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates, Pc
state: Georgia
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists Of Central Illinois
state: Illinois
city: Naperville
country: United States
facility: Edward Cancer Center
state: Illinois
city: Normal
country: United States
facility: Mid-Illinois Hematology & Oncology Associates, Ltd
state: Illinois
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Assoc., Llp
state: Iowa
city: Hutchinson
country: United States
facility: Hutchinson Clinic, Pa
state: Kansas
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Baltimore
country: United States
facility: The Bunting-Blaustein Cancer Research Building
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital Regional Cancer Therapy Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Veterans Affairs Medical Center
state: Missouri
city: Springfield
country: United States
facility: St Johns Medical Research Institute, Inc.
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: University Of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke'S Hospital & Health Network Laboratory
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Va Pittsburgh Healthcare System
state: Pennsylvania
city: Upland
country: United States
facility: Associates In Hematology & Oncology, P.C.
state: Pennsylvania
city: Charleston
country: United States
facility: Musc Hollings Cancer Center
state: South Carolina
city: Dallas
country: United States
facility: Center For Oncology Research & Treatment, P.A.
state: Texas
city: Fort Worth
country: United States
facility: The Center For Cancer And Blood Disorders
state: Texas
city: Houston
country: United States
facility: The University Of Texas Md Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Northwest Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Huntington
country: United States
facility: Edwards Comprehensive Cancer Center
state: West Virginia
city: Caba
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: La Rioja
country: Argentina
facility: Local Institution
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Frankston
country: Australia
facility: Local Institution
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Subiaco
country: Australia
facility: Local Institution
state: Western Australia
city: Salzburg
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Roeselare
country: Belgium
facility: Local Institution
city: Fortaleza
country: Brazil
facility: Local Institution
state: Ceara
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Ijui
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Curitiba
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Divinopolis
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Mogi Das Cruzes
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Greenfield Park
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Temuco
country: Chile
facility: Local Institution
state: Araucania
city: Santiago - Independencia
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago De Chile
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Vi?a Del Mar
country: Chile
facility: Local Institution
state: Valparaiso
city: Monteria
country: Colombia
facility: Local Institution
state: Cordoba
city: Bogota
country: Colombia
facility: Local Institution
city: Brno
country: Czech Republic
facility: Local Institution
city: Hradec Kralove
country: Czech Republic
facility: Local Institution
city: Liberec
country: Czech Republic
facility: Local Institution
city: Aalborg
country: Denmark
facility: Local Institution
city: Aarhus
country: Denmark
facility: Local Institution
city: Herlev
country: Denmark
facility: Local Institution
city: Kobenhavn O
country: Denmark
facility: Local Institution
city: Odense C
country: Denmark
facility: Local Institution
city: Besancon Cedex
country: France
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Clermont-ferrand
country: France
facility: Local Institution
city: Marseille Cedex 20
country: France
facility: Local Institution
city: Pointe A Pitre
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Bonn
country: Germany
facility: Local Institution
city: Eschweiler
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Wuppertal
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Gyula
country: Hungary
facility: Local Institution
city: Kaposvar
country: Hungary
facility: Local Institution
city: Kecskemet
country: Hungary
facility: Local Institution
city: Dublin 7
country: Ireland
facility: Local Institution
state: Dublin
city: Tallaght
country: Ireland
facility: Local Institution
state: Dublin
city: Dublin
country: Ireland
facility: Local Institution
city: Beer Jacob
country: Israel
facility: Local Institution
city: Beer-sheva
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Tel Hashomer
country: Israel
facility: Local Institution
city: Meldola (fc)
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Rimini
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Sondrio
country: Italy
facility: Local Institution
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Acapulco
country: Mexico
facility: Local Institution
state: Guerrero
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Puebla
country: Mexico
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Mb Amsterdam
country: Netherlands
facility: Local Institution
city: Arequipa
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Olsztyn
country: Poland
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Ponce School Of Medicine
city: Bucharest
country: Romania
facility: Local Institution
city: Romania
country: Romania
facility: Local Institution
city: Suceava
country: Romania
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Obninsk
country: Russian Federation
facility: Local Institution
city: St Petersburg
country: Russian Federation
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Benidorm-alicante
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Santiago De Compostela
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Chelmsford
country: United Kingdom
facility: Local Institution
state: Essex
city: Cardiff
country: United Kingdom
facility: Local Institution
state: Glamorgan
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Scunthorpe
country: United Kingdom
facility: Local Institution
state: Lincolnshire
city: Nottingham
country: United Kingdom
facility: Local Institution
state: Nottinghamshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.