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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01057810




Registration number
NCT01057810
Ethics application status
Date submitted
26/01/2010
Date registered
27/01/2010
Date last updated
18/08/2016

Titles & IDs
Public title
Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
Scientific title
Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer
Secondary ID [1] 0 0
2009-016217-23
Secondary ID [2] 0 0
CA184-095
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

Experimental: 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 the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or 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 the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) Time
Timepoint [1] 0 0
Randomization until death from any cause, up to April 2015, approximately 57 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) Time
Timepoint [1] 0 0
Randomization until disease progression, up to April 2015, approximately 57 months
Secondary outcome [2] 0 0
Time to Subsequent Non-hormonal Cytotoxic Therapy
Timepoint [2] 0 0
Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months
Secondary outcome [3] 0 0
Time to Pain Progression
Timepoint [3] 0 0
Randomization until pain progression, up to April 2015, approximately 57 months
Secondary outcome [4] 0 0
Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)
Timepoint [4] 0 0
Day 1 of study therapy to last dose plus 70 days
Secondary outcome [5] 0 0
Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities
Timepoint [5] 0 0
Randomization up to April 2015, approximately 57 months

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



* Metastatic prostate cancer
* Asymptomatic or minimally symptomatic
* Progression during hormonal therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Liver, lung or brain metastases
* Prior immunotherapy or chemotherapy for metastatic prostate cancer
* Autoimmune disease
* HIV, Hepatitis B, or Hepatitis C infection

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
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
837
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Kogarah
Recruitment hospital [2] 0 0
Local Institution - Ashford
Recruitment hospital [3] 0 0
Local Institution - Box Hill
Recruitment hospital [4] 0 0
Local Institution - East Bentleigh
Recruitment hospital [5] 0 0
Local Institution - Frankston
Recruitment hospital [6] 0 0
Local Institution - Heidelberg
Recruitment hospital [7] 0 0
Local Institution - Subiaco
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5035 - Ashford
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
6008 - Subiaco
Recruitment outside Australia
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West Midlands

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo
Trial website
https://clinicaltrials.gov/study/NCT01057810
Trial related presentations / publications
de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01057810