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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:
NCT00861614
First received: March 12, 2009
Last updated: August 4, 2016
Last verified: August 2016

March 12, 2009
August 4, 2016
May 2009
November 2012   (final data collection date for primary outcome measure)
  • Overall Survival (OS) [ Time Frame: Date of randomization to date of death ] [ Designated as safety issue: No ]
    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.
  • Overall Survival Rate [ Time Frame: Date of randomization to date of death ] [ Designated as safety issue: No ]
    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.
Overall survival [ Time Frame: is assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00861614 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) [ Time Frame: Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death ] [ Designated as safety issue: No ]
    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.
  • Pain Response [ Time Frame: Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit ] [ Designated as safety issue: No ]
    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.
  • Duration of Pain Response [ Time Frame: Day of initial pain response to day of completion of pain response or date of death ] [ Designated as safety issue: No ]
    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.
  • 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) [ Time Frame: Randomization to date of death ] [ 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. 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.

  • Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE) [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    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.
  • Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE) [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    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.
  • Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR) [ Time Frame: Day 1 to time of onset of the imAR of interest ] [ Designated as safety issue: Yes ]

    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.

  • Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0 [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]

    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.

  • Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline [ Time Frame: Day 1 to 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    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.
  • Progression free survival (PFS) [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated. QoL assessments continue until lost to follow-up, withdrawal of consent, death, study closure ] [ Designated as safety issue: No ]
  • PSA response rate [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated. QoL assessments continue until lost to follow-up, withdrawal of consent, death, study closure ] [ Designated as safety issue: No ]
  • Characterize the kinetics of tumor burden [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated. QoL assessments continue until lost to follow-up, withdrawal of consent, death, study closure ] [ Designated as safety issue: No ]
  • Characterize PSA kinetics [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated. QoL assessments continue until lost to follow-up, withdrawal of consent, death, study closure ] [ Designated as safety issue: No ]
  • Compare pain response [ Time Frame: Aassessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated. QoL assessments continue until lost to follow-up, withdrawal of consent, death, study closure ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) [ Time Frame: Aassessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated. QoL assessments continue until lost to follow-up, withdrawal of consent, death, study closure ] [ Designated as safety issue: No ]
  • Changes in pain intensity [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated. QoL assessments continue until lost to follow-up, withdrawal of consent, death, study closure ] [ Designated as safety issue: No ]
  • Characterize safety profile [ Time Frame: Assessed at each study visit while on treatment and every 12 weeks in the post-treatment Follow-up Phase until alternative treatment is initiated. QoL assessments continue until lost to follow-up, withdrawal of consent, death, study closure ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Immunotherapy to Treat Advanced Prostate Cancer
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
    Other Name: BMS 734016
  • 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 Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure
  • Active Comparator: Ipilimumab
    Intervention: Drug: Ipilimumab
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
988
August 2015
November 2012   (final data collection date for primary outcome measure)

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   Peru,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain,   United Kingdom
 
NCT00861614
CA184-043, 2008-003314-97
Yes
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP