Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01057810
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ipilimumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 837 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Ipilimumab

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall Survival (OS) Time [ Time Frame: Randomization until death from any cause, up to April 2015, approximately 57 months ]
    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 :
  1. Progression-Free Survival (PFS) Time [ Time Frame: Randomization until disease progression, up to April 2015, approximately 57 months ]
    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.

  2. Time to Subsequent Non-hormonal Cytotoxic Therapy [ Time Frame: Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months ]
    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).

  3. Time to Pain Progression [ Time Frame: Randomization until pain progression, up to April 2015, approximately 57 months ]

    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.

  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) [ Time Frame: Day 1 of study therapy to last dose plus 70 days ]
    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.

  5. Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities [ Time Frame: Randomization up to April 2015, approximately 57 months ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

For more information regarding BMS clinical trial participation, please visit

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01057810

  Hide Study 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
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University Of Maryland
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21231
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Mayo Clinic
Rochester, Minnesota, United States, 55905
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Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
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Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, United States, 89148
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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
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Novant Health Oncology Specialists
Winston Salem, North Carolina, United States, 27103
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Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74136
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Kaiser Permanente Oncology/Hematology
Portland, Oregon, United States, 97227
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Portland, Oregon, United States, 97239
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St. Luke'S Hospital & Health Network Laboratory
Bethlehem, Pennsylvania, United States, 18015
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Cancer Center Of The Carolinas
Greenville, South Carolina, United States, 29615
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Myrtle Beach, South Carolina, United States, 29572
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Scott & White Memorial Hospital And Clinic
Temple, Texas, United States, 76508
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Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
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Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
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San Juan, Puerto Rico, 00921
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Guildford, Surrey, United Kingdom, GU2 7WG
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Birmingham, West Midlands, United Kingdom, B9 5SS
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT01057810     History of Changes
Other Study ID Numbers: CA184-095
2009-016217-23 ( EudraCT Number )
First Posted: January 27, 2010    Key Record Dates
Results First Posted: August 18, 2016
Last Update Posted: August 18, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases