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

  Show 134 Study Locations
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 August 25, 2016