Study of Immunotherapy to Treat Advanced Prostate Cancer
Tracking InformationStart Date ICMJE | May 2009 |
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Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) |
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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 ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00861614 on ClinicalTrials.gov Archive Site |
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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 ]
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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 ]
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Descriptive InformationBrief Title ICMJE | Study of Immunotherapy to Treat Advanced Prostate Cancer |
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Official Title ICMJE | 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 |
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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 |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Prostate Cancer |
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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
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Study Arms / Comparison Groups | |
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Recruitment InformationEstimated Enrollment ICMJE | 800 |
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Estimated Completion Date | December 2012 |
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Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) |
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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
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Gender | Male |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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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. | | | |
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Location Countries ICMJE | United 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 |
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Administrative InformationNCT ID ICMJE | NCT00861614 |
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Responsible Party | Study Director, Bristol-Myers Squibb |
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Study ID Numbers ICMJE | CA184-043, 2008-003314-97 |
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Study Sponsor ICMJE | Bristol-Myers Squibb |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb | |
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Information Provided By | Bristol-Myers Squibb |
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