Study of Immunotherapy to Treat Advanced Prostate Cancer


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2009)		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 ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00861614 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: January 5, 2010)
  • Compare 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 ] [ Designated as safety issue: No ]
  • Compare pain response [ Time Frame: Assessed at screening, weeks 12, 18, 24, and at the End of Treatment visit ] [ Designated as safety issue: No ]
  • Characterize safety profile [ Time Frame: Assessed at each study visit while on treatment and for 70 days following the last dose of study drug ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJE 
 (submitted: March 12, 2009)
  • 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 ]

Descriptive Information

Brief Title  ICMJEStudy of Immunotherapy to Treat Advanced Prostate Cancer
Official Title  ICMJEA 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
Brief Summary

The purpose of the study is to determine if advanced prostate cancer patient s that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEProstate Cancer
Intervention  ICMJE
  • 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
Study Arms / Comparison Groups
  • Ipilimumab: Active Comparator
    Intervention: Drug: Ipilimumab
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE800
Estimated Completion DateDecember 2012
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderMale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Ireland,   Italy,   Mexico,   Netherlands,   Peru,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00861614
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECA184-043, 2008-003314-97
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb