AzTrials
AzTrials

Prostate CancerPhase 3NCT00861614

Study of Immunotherapy to Treat Advanced Prostate Cancer

A Phase 3 study testing Ipilimumab in people with Prostate Cancer, run by Bristol-Myers Squibb at 158 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
988 participants
Where
158 sitesin 27 countries
Study dates
May 2009to Aug 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

158 sites in 27 countries.

158 sites in 27 countries

United States44 sites

  • Alaska Clinical Research Center, Llc

    Anchorage, Alaska, 99508

  • The Bunting-Blaustein Cancer Research Building

    Baltimore, Maryland, 21231

  • St. Luke'S Hospital & Health Network Laboratory

    Bethlehem, Pennsylvania, 18015

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Musc Hollings Cancer Center

    Charleston, South Carolina, 29445

  • University Of Chicago

    Chicago, Illinois, 60637

  • University Of Cincinnati

    Cincinnati, Ohio, 45267

  • Center For Oncology Research & Treatment, P.A.

    Dallas, Texas, 75230

  • Cancer Care Specialists Of Central Illinois

    Decatur, Illinois, 62526

  • Highlands Oncology Group, P.A.

    Fayetteville, Arkansas, 72703

  • The Center For Cancer And Blood Disorders

    Fort Worth, Texas, 76104

  • Marsha G. Fink, Md, Inc.

    Fountain Valley, California, 92708

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • The University Of Texas Md Anderson Cancer Center

    Houston, Texas, 77030

  • Northwest Cancer Center

    Houston, Texas, 77090

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Hutchinson Clinic, Pa

    Hutchinson, Kansas, 67502

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Suburban Hematology-Oncology Associates, Pc

    Lawrenceville, Georgia, 30046

  • Loma Linda University Cancer Center

    Loma Linda, California, 92350

  • Usc/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Prostate Oncology Specialists, Inc.

    Marina del Rey, California, 90292

  • Southern Cancer Center

    Mobile, Alabama, 36608

  • Edward Cancer Center

    Naperville, Illinois, 60540

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medical College

    New York, New York, 10065

  • Mid-Illinois Hematology & Oncology Associates, Ltd

    Normal, Illinois, 61761

  • Orlando Health, Inc

    Orlando, Florida, 32806

  • Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Va Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina, 27607

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Va San Diego Healthcare System

    San Diego, California, 92161

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • Siouxland Hematology-Oncology Assoc., Llp

    Sioux City, Iowa, 51101

  • St Johns Medical Research Institute, Inc.

    Springfield, Missouri, 65807

  • Arizona Clinical Research Center, Inc.

    Tucson, Arizona, 85715

  • Associates In Hematology & Oncology, P.C.

    Upland, Pennsylvania, 19013

Other trials in United States

Argentina13 sites

  • Local Institution

    Buenos Aires, Buenos Aires, 1019

  • Local Institution

    Buenos Aires, Buenos Aires, 1120

  • Local Institution

    Buenos Aires, Buenos Aires, C1280AEB

  • Local Institution

    Buenos Aires, Buenos Aires, C1426ANZ

  • Local Institution

    Caba, Buenos Aires, 1417

  • Local Institution

    Capital Federal, Buenos Aires, 1426

  • Local Institution

    Córdoba, Córdoba Province, X5002AOQ

  • Local Institution

    Córdoba, Córdoba Province, X5006HBF

  • Local Institution

    La Rioja, La Rioja Province, 5300

  • Local Institution

    Rosario, Santa Fe Province, 2000

  • Local Institution

    Rosario, Santa Fe Province, S2000DSK

  • Local Institution

    San Miguel de Tucumán, Tucumán Province, 4000

  • Local Institution

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Brazil10 sites

  • Local Institution

    Curitiba, Paraná, 80440

  • Local Institution

    Curitiba, São Paulo, 80530

  • Local Institution

    Divinopolis, São Paulo, 35500

  • Local Institution

    Fortaleza, Ceará, 60430

  • Local Institution

    Ijuí, Rio Grande do Sul, 98700000

  • Local Institution

    Mogi das Cruzes, São Paulo, 08730

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90430

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90610

  • Local Institution

    São Paulo, São Paulo, 05403

  • Local Institution

    São Paulo, São Paulo, 09060

Other trials in Brazil

Mexico7 sites

  • Local Institution

    Acapulco de Juárez, Guerrero, 39570

  • Local Institution

    Aguascalientes, Aguascalientes, 20234

  • Local Institution

    Cuernavaca, Morelos, 62290

  • Local Institution

    Df, Mexico City, 06720

  • Local Institution

    Guadalajara, Jalisco

  • Local Institution

    Mexico City, Mexico City, 07760

  • Local Institution

    Puebla City, Puebla, 72270

Other trials in Mexico

France6 sites

  • Local Institution

    Besançon, 25030

  • Local Institution

    Bordeaux, 33076

  • Local Institution

    Clermont-Ferrand, 63000

  • Local Institution

    Marseille, 13915

  • Local Institution

    Pointe à Pitre, 97159

  • Local Institution

    Villejuif, 94800

Other trials in France

Italy6 sites

  • Local Institution

    Meldola (fc), 47014

  • Local Institution

    Milan, 20132

  • Local Institution

    Naples, 80131

  • Local Institution

    Rimini, 47900

  • Local Institution

    Siena, 53100

  • Local Institution

    Sondrio, 23100

Other trials in Italy

Spain6 sites

  • Local Institution

    Barcelona, 08035

  • Local Institution

    Barcelona, 08208

  • Local Institution

    Benidorm-alicante, 03501

  • Local Institution

    Madrid, 28922

  • Local Institution

    Santiago de Compostela, 157706

  • Local Institution

    Valencia, 46009

Other trials in Spain

Chile5 sites

  • Local Institution

    Santiago, Santiago Metropolitan, 7510032

  • Local Institution

    Santiago, Santiago Metropolitan, 7650635

  • Local Institution

    Santiago - Independencia, Santiago Metropolitan

  • Local Institution

    Temuco, Araucania

  • Local Institution

    Vi?a Del Mar, Valparaiso

Other trials in Chile

Denmark5 sites

  • Local Institution

    Aalborg, 9000

  • Local Institution

    Aarhus, 8000

  • Local Institution

    Herlev, 2730

  • Local Institution

    København Ø, 2100

  • Local Institution

    Odense C, 5000

Other trials in Denmark

Germany5 sites

  • Local Institution

    Berlin, 14197

  • Local Institution

    Bonn, 53127

  • Local Institution

    Eschweiler, 52249

  • Local Institution

    Mannheim, 68167

  • Local Institution

    Wuppertal, 42103

Other trials in Germany

Israel5 sites

  • Local Institution

    Beer Jacob, 70300

  • Local Institution

    Beersheba, 84101

  • Local Institution

    Haifa, 31096

  • Local Institution

    Tel Aviv, 64239

  • Local Institution

    Tel HaShomer, 52621

Other trials in Israel

Peru5 sites

  • Local Institution

    Arequipa, AREQUIPA54

  • Local Institution

    Lima, Lima Province, 18

  • Local Institution

    Lima, Lima Province, 34

  • Local Institution

    Lima, Lima Province, L-27

  • Local Institution

    Lima, Lima Province, LIMA 11

Other trials in Peru

Russia5 sites

  • Local Institution

    Moscow, 115478

  • Local Institution

    Moscow, 117997

  • Local Institution

    Moscow, 129128

  • Local Institution

    Obninsk, 249036

  • Local Institution

    Saint Petersburg, 197758

Other trials in Russia

United Kingdom5 sites

  • Local Institution

    Cardiff, Glamorgan, CF14 2TL

  • Local Institution

    Chelmsford, Essex, CM1 7ET

  • Local Institution

    Manchester, Greater Manchester, M20 4BX

  • Local Institution

    Nottingham, Nottinghamshire, NG5 1PB

  • Local Institution

    Scunthorpe, Lincolnshire, DN15 7BH

Other trials in United Kingdom

Australia4 sites

  • Local Institution

    Box Hill, Victoria, 3128

  • Local Institution

    Frankston, Victoria, 3199

  • Local Institution

    Heidelberg, Victoria, 3084

  • Local Institution

    Subiaco, Western Australia, 6008

Other trials in Australia

Belgium4 sites

  • Local Institution

    Brussels, 1000

  • Local Institution

    Brussels, 1090

  • Local Institution

    Brussels, 1200

  • Local Institution

    Roeselare, 8800

Other trials in Belgium

Hungary4 sites

  • Local Institution

    Budapest, 1122

  • Local Institution

    Gyula, 5700

  • Local Institution

    Kaposvár, 7400

  • Local Institution

    Kecskemét, 6000

Other trials in Hungary

Czechia3 sites

  • Local Institution

    Brno, 656 91

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Liberec, 460 63

Other trials in Czechia

Romania3 sites

  • Local Institution

    Bucharest, 011172

  • Local Institution

    Romania, 400015

  • Local Institution

    Suceava, 720237

Other trials in Romania

Austria2 sites

  • Local Institution

    Salzburg, 5020

  • Local Institution

    Vienna, 1090

Other trials in Austria

Canada2 sites

  • Local Institution

    Greenfield Park, Quebec, J4V 2H1

  • Local Institution

    Montreal, Quebec, H2L 4M1

Other trials in Canada

Colombia2 sites

  • Local Institution

    Bogotá

  • Local Institution

    Montería, Departamento de Córdoba

Other trials in Colombia

Ireland2 sites

  • Local Institution

    Dublin, Dublin

  • Local Institution

    Tallaght, Dublin, DUBLIN 24

Other trials in Ireland

Netherlands2 sites

  • Local Institution

    Amsterdam, 1066 CX

  • Local Institution

    Mb Amsterdam, 1007MB

Other trials in Netherlands

Greece1 site

  • Local Institution

    Athens, 115 28

Other trials in Greece

Poland1 site

  • Local Institution

    Olsztyn, 10-228

Other trials in Poland

Puerto Rico1 site

  • Ponce School Of Medicine

    Ponce, 00716

Other trials in Puerto Rico

About this study

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

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

Conditions
Prostate Cancer
Being tested
Ipilimumab, Placebo
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IpilimumabDrug

    Also called BMS 734016

    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

  • PlaceboDrug

    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

Study groups in NCT00861614
Study groupRoleWhat they receive
IpilimumabActive comparatorNot described
Receives: Drug: Ipilimumab
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Date of randomization to date of death

  2. 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.

    Measured: Date of randomization to date of death

Secondary outcomes (12)

  1. 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.

    Measured: Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death

  2. 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.

    Measured: Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit

  3. 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.

    Measured: Day of initial pain response to day of completion of pain response or date of death

  4. 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.

    Measured: Randomization to date of death

  5. 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.

    Measured: Day 1 to 70 days after last dose of study drug

  6. 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.

    Measured: Day 1 to 70 days after last dose of study drug

  7. 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.

    Measured: Day 1 to time of onset of the imAR of interest

  8. 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.

    Measured: Day 1 to 70 days after last dose of study drug

  9. 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.

    Measured: Day 1 to 70 days after last dose of study drug

  10. 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.

    Measured: Day 1 to 70 days after last dose of study drug

  11. 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.

    Measured: Day 1 to 70 days after last dose of study drug

  12. 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.

    Measured: Day 1 to 70 days after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionNov 2012
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
988 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00861614
Sponsor's protocol ID
CA184-043
Other IDs
2008-003314-97, 2008
Status last verified
Aug 2016
First submitted
12 Mar 2009
Last updated
30 Sep 2016
Data monitoring committee
Yes

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: 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.

    PubMed 25907621

  • 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.

    PubMed 24831977

  • 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.

    PubMed 21917607

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ipilimumab in people with Prostate Cancer, run by Bristol-Myers Squibb at 158 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Argentina, Brazil, Mexico, France and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Date of randomization to date of death). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00861614, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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