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Prostate CancerPhase 3NCT01057810

Phase 3 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 134 sites in 24 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 this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo 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
837 participants
Where
134 sitesin 24 countries
Study dates
Jul 2010to Jul 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

  • Metastatic prostate cancer
  • Asymptomatic or minimally symptomatic
  • Progression during hormonal therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

Who cannot join

  • Liver, lung or brain metastases
  • Prior immunotherapy or chemotherapy for metastatic prostate cancer
  • Autoimmune disease
  • HIV, Hepatitis B, or Hepatitis C infection

Trial locations and contacts

134 sites in 24 countries.

134 sites in 24 countries

United States42 sites

  • Alaska Clinical Research Center, Llc

    Anchorage, Alaska, 99508

  • Northside Hospital

    Atlanta, Georgia, 30341

  • Georgia Regents University

    Augusta, Georgia, 30912

  • University Of Maryland

    Baltimore, Maryland, 21201

  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

    Baltimore, Maryland, 21231

  • St. Luke'S Hospital & Health Network Laboratory

    Bethlehem, Pennsylvania, 18015

  • Lynn Cancer Institute Center For Hematology-Oncology

    Boca Raton, Florida, 33486

  • University Of Chicago

    Chicago, Illinois, 60637

  • Cancer Care Specialists Of Central Illinois

    Decatur, Illinois, 62526

  • North Shore Hematology/Oncology Associates, P.C.

    East Setauket, New York, 11733

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • Goshen Center For Cancer Care

    Goshen, Indiana, 46526

  • Goshen Medical Associates

    Goshen, New York, 10924

  • Cancer Center Of The Carolinas

    Greenville, South Carolina, 29615

  • Straub Clinic And Hospital

    Honolulu, Hawaii, 96813

  • Hutchinson Clinic, Pa

    Hutchinson, Kansas, 67502

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Comprehensive Cancer Centers Of Nevada

    Las Vegas, Nevada, 89148

  • Gwinnett Hospital System Inc.

    Lawrenceville, Georgia, 30046

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Md Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Hematology Oncology Associates Of The Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Kaiser Permanente Oncology/Hematology

    Portland, Oregon, 97227

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Desert Hematology Oncology

    Rancho Mirage, California, 92270

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Southern California Permanente Medical Group

    San Diego, California, 92108

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Suny Upstate Medical University

    Syracuse, New York, 13210

  • Scott & White Memorial Hospital And Clinic

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Tulsa Cancer Institute

    Tulsa, Oklahoma, 74136

  • George Washington University

    Washington D.C., District of Columbia, 20037

  • Cancer Center Of Kansas

    Wichita, Kansas, 67214

  • Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

Other trials in United States

Argentina7 sites

  • Local Institution

    Buenos Aires, Buenos Aires, 1120

  • Local Institution

    Buenos Aires, Buenos Aires, C1280AEB

  • Local Institution

    Buenos Aires, Buenos Aires, C1426BOS

  • Local Institution

    Córdoba, Córdoba Province, X5006HBF

  • Local Institution

    La Rioja, La Rioja Province, 5300

  • Local Institution

    Rosario, Santa Fe Province, S2000DSK

  • Local Institution

    Rosario, Santa Fe Province, S2000DSV

Other trials in Argentina

Australia7 sites

  • Local Institution

    Ashford, South Australia, 5035

  • Local Institution

    Box Hill, Victoria, 3128

  • Local Institution

    East Bentleigh, Victoria, 3165

  • Local Institution

    Frankston, Victoria, 3199

  • Local Institution

    Heidelberg, Victoria, 3084

  • Local Institution

    Kogarah, New South Wales, 2217

  • Local Institution

    Subiaco, Western Australia, 6008

Other trials in Australia

Mexico7 sites

  • Local Institution

    Guadalajara, Jalisco, 44280

  • Local Institution

    México, Querétaro, 76200

  • Local Institution

    Mexico City, Mexico City, 06726

  • Local Institution

    Mexico City, Mexico City, 07760

  • Local Institution

    San Luis Potosí City, San Luis Potosí, 78240

  • Local Institution

    Tlalpan, Mexico City, 14080

  • Local Institution

    Zapopan, Jalisco, 45150

Other trials in Mexico

Poland7 sites

  • Local Institution

    Gdansk, 80-402

  • Local Institution

    Kościerzyna, 83-400

  • Local Institution

    Krakow, 30-017

  • Local Institution

    Kutno, 99-300

  • Local Institution

    Lublin, 20-090

  • Local Institution

    Poznan, 60-693

  • Local Institution

    Słupsk, 76-200

Other trials in Poland

France6 sites

  • Local Institution

    Bordeaux, 33075

  • Local Institution

    Clermont-Ferrand, 63000

  • Local Institution

    Marseille, 13273

  • Local Institution

    Pointe à Pitre, 97159

  • Local Institution

    Poitiers, 86000

  • Local Institution

    Villejuif, 94805

Other trials in France

Brazil5 sites

  • Local Institution

    Belo Horizonte, Minas Gerais, 30150

  • Local Institution

    Belo Horizonte - Mg, Minas Gerais, 31150

  • Local Institution

    Brasília, Federal District, 72115

  • Local Institution

    Ijuí, Rio Grande do Sul, 98700

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90430

Other trials in Brazil

Germany5 sites

  • Local Institution

    Aachen, 52074

  • Local Institution

    Heidelberg, 69120

  • Local Institution

    Marktredwitz, 95615

  • Local Institution

    Munich, 81675

  • Local Institution

    Wesel, 46483

Other trials in Germany

Spain5 sites

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Barcelona, 08907

  • Local Institution

    Madrid, 28040

  • Local Institution

    Seville, 41071

  • Local Institution

    Valencia, 46009

Other trials in Spain

Turkey (Türkiye)5 sites

  • Local Institution

    Adana, 01330

  • Local Institution

    Bornova, Izmir, 35100

  • Local Institution

    Gaziantep, 27310

  • Local Institution

    Kocaeli, 41380

  • Local Institution

    Kocaeli, 41400

Other trials in Turkey (Türkiye)

Colombia4 sites

  • Local Institution

    Bogotá

  • Local Institution

    Bucaramanga

  • Local Institution

    Medellín, MEDELLIN

  • Local Institution

    Montería, Departamento de Córdoba

Other trials in Colombia

Czechia4 sites

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Liberec, 460 63

  • Local Institution

    Prague, 150 30

  • Local Institution

    Prague, 180 81

Other trials in Czechia

Hungary4 sites

  • Local Institution

    Budapest, 1064

  • Local Institution

    Budapest, 1145

  • Local Institution

    Gyula, 5700

  • Local Institution

    Székesfehérvár, H-8000

Other trials in Hungary

Italy4 sites

  • Local Institution

    Meldola (FC), 47014

  • Local Institution

    Milan, I-20132

  • Local Institution

    Siena, 53100

  • Local Institution

    Terni, 05100

Other trials in Italy

Canada3 sites

  • Local Institution

    Kingston, Ontario, K7L 2V7

  • Local Institution

    Montreal, Quebec, H2X 0A9

  • Local Institution

    Québec, Quebec, G1R 2J6

Other trials in Canada

Chile3 sites

  • Local Institution

    Santiago

  • Local Institution

    Temuco, Araucania, 4810469

  • Local Institution

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Romania3 sites

  • Local Institution

    Bucharest, 022328

  • Local Institution

    Cluj-napoca, Cluj County, 400046

  • Local Institution

    Timisoara,timis County, 300376

Other trials in Romania

Sweden3 sites

  • Local Institution

    Stockholm, 171 76

  • Local Institution

    Uppsala, 751 85

  • Local Institution

    Vaxjo, 351 85

Other trials in Sweden

United Kingdom3 sites

  • Local Institution

    Birmingham, West Midlands, B9 5SS

  • Local Institution

    Glasgow, Lanarkshire, G12 0YN

  • Local Institution

    Guildford, Surrey, GU2 7WG

Other trials in United Kingdom

Denmark2 sites

  • Local Institution

    Herlev, 2730

  • Local Institution

    København Ø, 2100

Other trials in Denmark

Netherlands2 sites

  • Local Institution

    Amsterdam, 1081HV

  • Local Institution

    Sittard-geleen, 6162 BG

Other trials in Netherlands

Greece1 site

  • Local Institution

    Athens, 115 28

Other trials in Greece

Norway1 site

  • Local Institution

    Kristiansand, 4604

Other trials in Norway

Puerto Rico1 site

  • Va Caribbean Healthcare System

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer

The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

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, MDX010

    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 the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or 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 the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure

Study groups in NCT01057810
Study groupRoleWhat they receive
IpilimumabExperimentalNot 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) Time

    OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.

    Measured: Randomization until death from any cause, up to April 2015, approximately 57 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS) Time

    Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.

    Measured: Randomization until disease progression, up to April 2015, approximately 57 months

  2. Time to Subsequent Non-hormonal Cytotoxic Therapy

    For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).

    Measured: Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months

  3. Time to Pain Progression

    Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of >= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of >= 25% from baseline (for participants with baseline AS > 10) or increase in mean AS >= 10 points from baseline (for participants with baseline AS <= 10).

    Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism.

    Measured: Randomization until pain progression, up to April 2015, approximately 57 months

  4. Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)

    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. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

    Measured: Day 1 of study therapy to last dose plus 70 days

  5. Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities

    NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria:

    White blood cells (WBC): Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L.

    Platelet count: Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin: Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - <0.5*10^9/L, Gr 4: <0.2*10^9/L.

    Lipase: Gr 3:> 2.0 - 5.0 * ULN; Gr 4: > 5.0 X ULN. Amylase: Gr 3: > 2.0 - 5.0 * ULN; Gr 4: > 5.0 * ULN. Alanine Aminotransferase (ALT) Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST): Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Bilirubin: Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase: Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Creatinine: Gr 3: > 3.0-6.0 * ULN, Gr 4: >6.0 * ULN.

    Measured: Randomization up to April 2015, approximately 57 months

Timeline

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

  1. First posted27 Jan 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionApr 2015
  4. Study completionJul 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
837 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01057810
Sponsor's protocol ID
CA184-095
Other IDs
2009-016217-23, 2009
Status last verified
Jul 2016
First submitted
26 Jan 2010
Last updated
18 Aug 2016
Data monitoring committee
Yes

Publications

  • de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

    PubMed 24722180

  • 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 134 sites in 24 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 4 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Argentina, Australia, Mexico, Poland and 19 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 18 Aug 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 (time frame: Randomization until death from any cause, up to April 2015, approximately 57 months). 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 NCT01057810, which also lists 2 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 18 Aug 2016.

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