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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00861614




Registration number
NCT00861614
Ethics application status
Date submitted
12/03/2009
Date registered
13/03/2009
Date last updated
30/09/2016

Titles & IDs
Public title
Study of Immunotherapy to Treat Advanced Prostate Cancer
Scientific title
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
Secondary ID [1] 0 0
2008-003314-97
Secondary ID [2] 0 0
CA184-043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Placebo

Active comparator: Ipilimumab -

Placebo comparator: Placebo -


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Date of randomization to date of death
Primary outcome [2] 0 0
Overall Survival Rate
Timepoint [2] 0 0
Date of randomization to date of death
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death
Secondary outcome [2] 0 0
Pain Response
Timepoint [2] 0 0
Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit
Secondary outcome [3] 0 0
Duration of Pain Response
Timepoint [3] 0 0
Day of initial pain response to day of completion of pain response or date of death
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Randomization to date of death
Secondary outcome [5] 0 0
Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)
Timepoint [5] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [6] 0 0
Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)
Timepoint [6] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [7] 0 0
Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)
Timepoint [7] 0 0
Day 1 to time of onset of the imAR of interest
Secondary outcome [8] 0 0
Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0
Timepoint [8] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [9] 0 0
Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline
Timepoint [9] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [10] 0 0
Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline
Timepoint [10] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [11] 0 0
Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline
Timepoint [11] 0 0
Day 1 to 70 days after last dose of study drug
Secondary outcome [12] 0 0
Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline
Timepoint [12] 0 0
Day 1 to 70 days after last dose of study drug

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.



* Advanced prostate cancer
* At least 1 bone metastasis
* Testosterone < 50 ng/dl
* Prior treatment with docetaxel
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
988
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Box Hill
Recruitment hospital [2] 0 0
Local Institution - Frankston
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - Subiaco
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
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State/province [3] 0 0
Arizona
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Arkansas
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California
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Florida
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Georgia
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Illinois
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Iowa
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Minnesota
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Missouri
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Utah
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Tucuman
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Eschweiler
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Valencia
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Essex
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Glamorgan
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Greater Manchester
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Lincolnshire
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Nottinghamshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00861614