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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Ipilimumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 988
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Local Institution
  • Buenos Aires, Argentina, C1426ANZ
    • Local Institution
  • Buenos Aires, Argentina, 1019
    • Local Institution
  • Buenos Aires, Argentina, 1120
    • Local Institution
  • Cordoba, Argentina, X5006HBF
    • Local Institution
  • Cordoba, Argentina, X5002AOQ
    • Local Institution
  • La Rioja, Argentina, 5300
    • Local Institution
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, 1417
      • Local Institution
    • Capital Federal, Buenos Aires, Argentina, 1426
      • Local Institution
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Local Institution
    • Rosario, Santa Fe, Argentina, S2000DSK
      • Local Institution
  • Tucuman
    • San Miguel De Tucuman, Tucuman, Argentina, 4000
      • Local Institution
    • San Miguel De Tucuman, Tucuman, Argentina, T4000IAK
      • Local Institution
• Australia
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Local Institution
    • Frankston, Victoria, Australia, 3199
      • Local Institution
    • Heidelberg, Victoria, Australia, 3084
      • Local Institution
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • Local Institution
• Austria
  • Salzburg, Austria, 5020
    • Local Institution
  • Wien, Austria, 1090
    • Local Institution
• Belgium
  • Brussels, Belgium, 1090
    • Local Institution
  • Bruxelles, Belgium, 1200
    • Local Institution
  • Bruxelles, Belgium, 1000
    • Local Institution
  • Roeselare, Belgium, 8800
    • Local Institution
• Brazil
  • Sao Paulo, Brazil, 05403
    • Local Institution
  • Sao Paulo, Brazil, 09060
    • Local Institution
  • Ceara
    • Fortaleza, Ceara, Brazil, 60430
      • Local Institution
  • Parana
    • Curitiba, Parana, Brazil, 80440
      • Local Institution
  • Rio Grande Do Sul
    • Ijui, Rio Grande Do Sul, Brazil, 98700000
      • Local Institution
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610
      • Local Institution
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90430
      • Local Institution
  • Sao Paulo
    • Curitiba, Sao Paulo, Brazil, 80530
      • Local Institution
    • Divinopolis, Sao Paulo, Brazil, 35500
      • Local Institution
    • Mogi Das Cruzes, Sao Paulo, Brazil, 08730
      • Local Institution
• Canada
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Local Institution
    • Montreal, Quebec, Canada, H2L 4M1
      • Local Institution
• Chile
  • Araucania
    • Temuco, Araucania, Chile
      • Local Institution
  • Metropolitana
    • Santiago, Metropolitana, Chile, 7510032
      • Local Institution
    • Santiago - Independencia, Metropolitana, Chile
      • Local Institution
    • Santiago De Chile, Metropolitana, Chile, 7650635
      • Local Institution
  • Valparaiso
    • Vi?a Del Mar, Valparaiso, Chile
      • Local Institution
• Colombia
  • Bogota, Colombia
    • Local Institution
  • Cordoba
    • Monteria, Cordoba, Colombia
      • Local Institution
• Czech Republic
  • Brno, Czech Republic, 656 91
    • Local Institution
  • Hradec Kralove, Czech Republic, 500 05
    • Local Institution
  • Liberec, Czech Republic, 460 63
    • Local Institution
• Denmark
  • Aalborg, Denmark, 9000
    • Local Institution
  • Aarhus, Denmark, 8000
    • Local Institution
  • Herlev, Denmark, 2730
    • Local Institution
  • Kobenhavn O, Denmark, 2100
    • Local Institution
  • Odense C, Denmark, 5000
    • Local Institution
• France
  • Besancon Cedex, France, 25030
    • Local Institution
  • Bordeaux, France, 33076
    • Local Institution
  • Clermont-ferrand, France, 63000
    • Local Institution
  • Marseille Cedex 20, France, 13915
    • Local Institution
  • Pointe A Pitre, France, 97159
    • Local Institution
  • Villejuif Cedex, France, 94800
    • Local Institution
• Germany
  • Berlin, Germany, 14197
    • Local Institution
  • Bonn, Germany, 53127
    • Local Institution
  • Eschweiler, Germany, 52249
    • Local Institution
  • Mannheim, Germany, 68167
    • Local Institution
  • Wuppertal, Germany, 42103
    • Local Institution
• Greece
  • Athens, Greece, 115 28
    • Local Institution
• Hungary
  • Budapest, Hungary, 1122
    • Local Institution
  • Gyula, Hungary, 5700
    • Local Institution
  • Kaposvar, Hungary, 7400
    • Local Institution
  • Kecskemet, Hungary, 6000
    • Local Institution
• Ireland
  • Dublin, Ireland
    • Local Institution
  • Dublin
    • Dublin 7, Dublin, Ireland
      • Local Institution
    • Tallaght, Dublin, Ireland, DUBLIN 24
      • Local Institution
• Israel
  • Beer Jacob, Israel, 70300
    • Local Institution
  • Beer-sheva, Israel, 84101
    • Local Institution
  • Haifa, Israel, 31096
    • Local Institution
  • Tel Aviv, Israel, 64239
    • Local Institution
  • Tel Hashomer, Israel, 52621
    • Local Institution
• Italy
  • Meldola (fc), Italy, 47014
    • Local Institution
  • Milano, Italy, 20132
    • Local Institution
  • Napoli, Italy, 80131
    • Local Institution
  • Rimini, Italy, 47900
    • Local Institution
  • Siena, Italy, 53100
    • Local Institution
  • Sondrio, Italy, 23100
    • Local Institution
• Mexico
  • Aguascalientes, Mexico, 20234
    • Local Institution
  • Puebla, Mexico, 72270
    • Local Institution
  • Distrito Federal
    • Df, Distrito Federal, Mexico, 06720
      • Local Institution
    • Mexico, Distrito Federal, Mexico, 07760
      • Local Institution
  • Guerrero
    • Acapulco, Guerrero, Mexico, 39570
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • Local Institution
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62290
      • Local Institution
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Local Institution
  • Mb Amsterdam, Netherlands, 1007MB
    • Local Institution
• Peru
  • Arequipa, Peru, AREQUIPA54
    • Local Institution
  • Lima, Peru, LIMA 11
    • Local Institution
  • Lima, Peru, 34
    • Local Institution
  • Lima, Peru, L-27
    • Local Institution
  • Lima, Peru, 18
    • Local Institution
• Poland
  • Olsztyn, Poland, 10-228
    • Local Institution
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine
• Romania
  • Bucharest, Romania, 011172
    • Local Institution
  • Romania, Romania, 400015
    • Local Institution
  • Suceava, Romania, 720237
    • Local Institution
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Local Institution
  • Moscow, Russian Federation, 129128
    • Local Institution
  • Moscow, Russian Federation, 117997
    • Local Institution
  • Obninsk, Russian Federation, 249036
    • Local Institution
  • St Petersburg, Russian Federation, 197758
    • Local Institution
• Spain
  • Barcelona, Spain, 08208
    • Local Institution
  • Barcelona, Spain, 08035
    • Local Institution
  • Benidorm-alicante, Spain, 03501
    • Local Institution
  • Madrid, Spain, 28922
    • Local Institution
  • Santiago De Compostela, Spain, 157706
    • Local Institution
  • Valencia, Spain, 46009
    • Local Institution
• United Kingdom
  • Essex
    • Chelmsford, Essex, United Kingdom, CM1 7ET
      • Local Institution
  • Glamorgan
    • Cardiff, Glamorgan, United Kingdom, CF14 2TL
      • Local Institution
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M20 4BX
      • Local Institution
  • Lincolnshire
    • Scunthorpe, Lincolnshire, United Kingdom, DN15 7BH
      • Local Institution
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Local Institution
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Southern Cancer Center
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Clinical Research Center, LLC
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Arizona Clinical Research Center, Inc.
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group, P.A.
  • California
    • Fountain Valley, California, United States, 92708
      • Marsha G. Fink, Md, Inc.
    • Loma Linda, California, United States, 92350
      • Loma Linda University Cancer Center
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center
    • Marina Del Rey, California, United States, 90292
      • Prostate Oncology Specialists, Inc.
    • Palm Springs, California, United States, 92262
      • Comprehensive Cancer Center
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System
    • San Francisco, California, United States, 94115
      • Pacific Hematology Oncology Associates
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Cancer Institute
    • Orlando, Florida, United States, 32806
      • Orlando Health, Inc
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Suburban Hematology-Oncology Associates, PC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Decatur, Illinois, United States, 62526
      • Cancer Care Specialists of Central Illinois
    • Naperville, Illinois, United States, 60540
      • Edward Cancer Center
    • Normal, Illinois, United States, 61761
      • Mid-Illinois Hematology & Oncology Associates, Ltd
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
    • Sioux City, Iowa, United States, 51101
      • Siouxland Hematology-Oncology Assoc., Llp
  • Kansas
    • Hutchinson, Kansas, United States, 67502
      • Hutchinson Clinic, Pa
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Kentucky Cancer Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • The Bunting-Blaustein Cancer Research Building
    • Frederick, Maryland, United States, 21701
      • Frederick Memorial Hospital Regional Cancer Therapy Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Kansas City Veterans Affairs Medical Center
    • Springfield, Missouri, United States, 65807
      • St Johns Medical Research Institute, Inc.
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Hematology Oncology Associates
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke'S Hospital & Health Network Laboratory
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System
    • Upland, Pennsylvania, United States, 19013
      • Associates In Hematology & Oncology, P.C.
  • South Carolina
    • Charleston, South Carolina, United States, 29445
      • MUSC Hollings Cancer Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Center For Oncology Research & Treatment, P.A.
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77090
      • Northwest Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Edwards Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
Active Comparator: 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure; Other Names: BMS 734016

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	All PFS events were based on investigator's assessment. Participants who were alive and did not experience a PFS event were censored at the earlier of the latest prostate-specific antigen (PSA) or radiological tumor assessment date. Participants who did not die, showed no clinical deterioration, and who had no recorded post-baseline PSA or radiological tumor assessment were censored at randomization date.	Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death
Pain Response	The percentage of participants with a pain response assessed using the Brief Pain Inventory Short Form (BPI-SF) completed by participants throughout the study in a daily diary log. Pain-evaluable participants were defined as those with a decrease in the average daily worst pain intensity by at least 30% from baseline, maintained over 2 consecutive evaluations without the use of any rescue analgesic medication or increase in analgesic use in the same time period.	Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit
Duration of Pain Response	The time between the initial date of pain response and completion date of pain response. The initial date when the pain response criterion was achieved was considered the pain response date. The earlier of date of death, date of tumor resection surgery, or date when pain response criterion was no longer met was considered the completion date of the pain response. If none of these scenarios occurred, the completion of the pain response was set to the last known alive date.	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)	AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug and grouped into gastrointestinal (GI), hepatic, skin, endocrine and neurological. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies. IrAEs/ imARs were graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0.	Randomization to date of death
Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)	The time between first dose of study drug and date of earliest Grade 3 or 4 irAE. These irAEs are AEs of unknown etiology, consistent with an immune phenomenon and considered as causally related to drug exposure. The five subcategories of irAE examined include gastrointestinal (GI), liver, skin, endocrine, and neurological and are graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.	Day 1 to 70 days after last dose of study drug
Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)	Time between the date of onset of a Grade 3 or 4 irAE and the date of improvement to Grade 1 or less or the worst grade at baseline.	Day 1 to 70 days after last dose of study drug
Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)	The time between first dose of study drug and date of earliest Grade 3 or 4 imAR. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies and graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0. Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action.	Day 1 to time of onset of the imAR of interest
Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0	Time between the date of onset of an imAR to the date of resolution date of the event or the last known date participant was alive if an event did not resolve. Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action.	Day 1 to 70 days after last dose of study drug
Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline	Comparison of baseline versus worst grade hematology laboratory tests as measured by white blood count (WBC), absolute neutrophil count (ANC), platelet count, hemoglobin and lymphocyte results. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for WBC were based on Gr 1: 3.0 - < Lower Limit of Normal (LLN); Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Abnormal values for Hemoglobin were based on Gr 1: 10.0 - < LLN; Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for ANC were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < LLN; Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.	Day 1 to 70 days after last dose of study drug
Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline	Comparison of baseline versus worst grade liver function as measured by alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and alkaline phosphatase (ALP). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.	Day 1 to 70 days after last dose of study drug
Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline	Comparison of baseline versus worst grade serum chemistry as measured by lipase and amylase analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for lipase: Gr1: > 1.0 - 1.5 * ULN; Gr2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0*ULN. Abnormal values for amylase: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN.	Day 1 to 70 days after last dose of study drug
Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline	Comparison of baseline versus worst grade renal function as measured by creatinine analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr).Gr 0: within normal range. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN.	Day 1 to 70 days after last dose of study drug

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: March 12, 2009
• First Submitted That Met QC Criteria: March 12, 2009
• First Posted (Estimate): March 13, 2009

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: August 4, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab
• Other Study ID Numbers: CA184-043; 2008-003314-97