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: July 23, 2014
Last verified: July 2014

March 12, 2009
July 23, 2014
May 2009
November 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00861614 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 patient s 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
Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
796
November 2012
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
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
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2014

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