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Trial record 1 of 1 for:    NCT01057810
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Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01057810
First received: January 26, 2010
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
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

Condition Intervention Phase
Prostate Cancer
Drug: Ipilimumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall Survival (OS) Time [ Time Frame: Randomization until death from any cause, up to April 2015, approximately 57 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS) Time [ Time Frame: Randomization until disease progression, up to April 2015, approximately 57 months ] [ Designated as safety issue: No ]
    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.

  • Time to Subsequent Non-hormonal Cytotoxic Therapy [ Time Frame: Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months ] [ Designated as safety issue: No ]
    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).

  • Time to Pain Progression [ Time Frame: Randomization until pain progression, up to April 2015, approximately 57 months ] [ Designated as safety issue: No ]

    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.


  • Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) [ Time Frame: Day 1 of study therapy to last dose plus 70 days ] [ Designated as safety issue: Yes ]
    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.

  • Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities [ Time Frame: Randomization up to April 2015, approximately 57 months ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 837
Study Start Date: July 2010
Study Completion Date: July 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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
Other Names:
  • BMS-734016
  • MDX010
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 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Liver, lung or brain metastases
  • Prior immunotherapy or chemotherapy for metastatic prostate cancer
  • Autoimmune disease
  • HIV, Hepatitis B, or Hepatitis C infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057810

  Hide Study Locations
Locations
United States, Alaska
Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States, 99508
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Desert Hematology Oncology
Rancho Mirage, California, United States, 92270
Southern California Permanente Medical Group
San Diego, California, United States, 92108
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Lynn Cancer Institute Center For Hematology-Oncology
Boca Raton, Florida, United States, 33486
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Md Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Hematology Oncology Associates Of The Treasure Coast
Port Saint Lucie, Florida, United States, 34952
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30341
Georgia Regents University
Augusta, Georgia, United States, 30912
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, United States, 30046
United States, Hawaii
Straub Clinic And Hospital
Honolulu, Hawaii, United States, 96813
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
Cancer Care Specialists Of Central Illinois
Decatur, Illinois, United States, 62526
United States, Indiana
Goshen Center For Cancer Care
Goshen, Indiana, United States, 46526
United States, Kansas
Hutchinson Clinic, Pa
Hutchinson, Kansas, United States, 67502
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Maryland
University Of Maryland
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, United States, 89148
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, United States, 11733
Goshen Medical Associates
Goshen, New York, United States, 10924
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Suny Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Novant Health Oncology Specialists
Winston Salem, North Carolina, United States, 27103
United States, Oklahoma
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Kaiser Permanente Oncology/Hematology
Portland, Oregon, United States, 97227
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke'S Hospital & Health Network Laboratory
Bethlehem, Pennsylvania, United States, 18015
United States, South Carolina
Cancer Center Of The Carolinas
Greenville, South Carolina, United States, 29615
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Scott & White Memorial Hospital And Clinic
Temple, Texas, United States, 76508
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Washington
Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
Argentina
Local Institution
Rosario, Santa Fe, Argentina, S2000DSK
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Rosario, Santa Fe, Argentina, S2000DSV
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Buenos Aires, Argentina, 1120
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Buenos Aires, Argentina, C1280AEB
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Buenos Aires, Argentina, C1426BOS
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Cordoba, Argentina, X5006HBF
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La Rioja, Argentina, 5300
Australia, New South Wales
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Kogarah, New South Wales, Australia, 2217
Australia, South Australia
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Ashford, South Australia, Australia, 5035
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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East Bentleigh, Victoria, Australia, 3165
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Frankston, Victoria, Australia, 3199
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Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
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Subiaco, Western Australia, Australia, 6008
Brazil
Local Institution
Brasilia, Distrito Federal, Brazil, 72115
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Belo Horizonte - Mg, Minas Gerais, Brazil, 31150
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Belo Horizonte, Minas Gerais, Brazil, 30150
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Ijui, Rio Grande Do Sul, Brazil, 98700
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Porto Alegre, Rio Grande Do Sul, Brazil, 90430
Canada, Ontario
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Kingston, Ontario, Canada, K7L 2V7
Canada, Quebec
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Montreal, Quebec, Canada, H2X 0A9
Canada
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Quebec, Canada, G1R 2J6
Chile
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Temuco, Araucania, Chile, 4810469
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Vina Del Mar, Valparaiso, Chile, 2540364
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Santiago, Chile
Colombia
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Monteria, Cordoba, Colombia
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Bogota, Colombia
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Bucaramanga, Colombia
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Medellin, Colombia, MEDELLIN
Czech Republic
Local Institution
Hradec Kralove, Czech Republic, 500 05
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Liberec, Czech Republic, 460 63
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Praha 5, Czech Republic, 150 30
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Praha 8, Czech Republic, 180 81
Denmark
Local Institution
Herlev, Denmark, 2730
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Kobenhavn O, Denmark, 2100
France
Local Institution
Bordeaux, France, 33075
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Clermont-ferrand, France, 63000
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Marseille Cedex 9, France, 13273
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Pointe A Pitre, France, 97159
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Poitiers, France, 86000
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Villejuif Cedex, France, 94805
Germany
Local Institution
Aachen, Germany, 52074
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Heidelberg, Germany, 69120
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Marktredwitz, Germany, 95615
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Munich, Germany, 81675
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Wesel, Germany, 46483
Greece
Local Institution
Athens, Greece, 115 28
Hungary
Local Institution
Budapest, Hungary, 1064
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Budapest, Hungary, 1145
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Gyula, Hungary, 5700
Local Institution
Szekesfehervar, Hungary, H-8000
Italy
Local Institution
Meldola (FC), Italy, 47014
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Milano, Italy, I-20132
Local Institution
Siena, Italy, 53100
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Terni, Italy, 05100
Mexico
Local Institution
Mexico City, Distrito Federal, Mexico, 06726
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Mexico, Distrito Federal, Mexico, 07760
Local Institution
Tlalpan, Distrito Federal, Mexico, 14080
Local Institution
Guadalajara, Jalisco, Mexico, 44280
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Zapopan, Jalisco, Mexico, 45150
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Mexico, Queretaro, Mexico, 76200
Local Institution
San Luis Potosi, Mexico, 78240
Netherlands
Local Institution
Amsterdam, Netherlands, 1081HV
Local Institution
Sittard-geleen, Netherlands, 6162 BG
Norway
Local Institution
Kristiansand, Norway, 4604
Poland
Local Institution
Gdansk, Poland, 80-402
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Koscierzyna, Poland, 83-400
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Krakow, Poland, 30-017
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Kutno, Poland, 99-300
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Lublin, Poland, 20-090
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Poznan, Poland, 60-693
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Slupsk, Poland, 76-200
Puerto Rico
Va Caribbean Healthcare System
San Juan, Puerto Rico, 00921
Romania
Local Institution
Bucuresti, Romania, 022328
Local Institution
Cluj-napoca, Cluj County, Romania, 400046
Local Institution
Timisoara,timis County, Romania, 300376
Spain
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 08907
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Madrid, Spain, 28040
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Sevilla, Spain, 41071
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Valencia, Spain, 46009
Sweden
Local Institution
Stockholm, Sweden, 171 76
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Uppsala, Sweden, 751 85
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Vaxjo, Sweden, 351 85
Turkey
Local Institution
Adana, Turkey, 01330
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Bornova, Izmir, Turkey, 35100
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Gaziantep, Turkey, 27310
Local Institution
Kocaeli, Turkey, 41380
Local Institution
Kocaeli, Turkey, 41400
United Kingdom
Local Institution
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Local Institution
Guildford, Surrey, United Kingdom, GU2 7WG
Local Institution
Birmingham, West Midlands, United Kingdom, B9 5SS
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01057810     History of Changes
Other Study ID Numbers: CA184-095  2009-016217-23 
Study First Received: January 26, 2010
Results First Received: March 7, 2016
Last Updated: July 11, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016