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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02279862




Registration number
NCT02279862
Ethics application status
Date submitted
29/10/2014
Date registered
31/10/2014
Date last updated
28/08/2019

Titles & IDs
Public title
Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive
Scientific title
A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic
Secondary ID [1] 0 0
2014-002987-34
Secondary ID [2] 0 0
CA184-437
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
Experimental: Arm 1: Ipilimumab 3 mg/kg - Ipilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose

Experimental: Arm 2: Ipilimumab 10 mg/kg - Ipilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-free Survival (rPFS)
Timepoint [1] 0 0
From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)
Secondary outcome [1] 0 0
Number of Participants Who Experienced Immune-related Adverse Events (irAEs)
Timepoint [1] 0 0
From first dose of ipilimumab to last dose plus 90 days
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization to death from any cause (assessed up to December 2016, approximately 24 months)
Secondary outcome [3] 0 0
Prostate Specific Antigen Progression-free Survival (PSA PFS)
Timepoint [3] 0 0
From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)
Secondary outcome [4] 0 0
Time to Pain Progression
Timepoint [4] 0 0
From randomization until pain progression (assessed up to December 2016, approximately 24 months)
Secondary outcome [5] 0 0
Prostate Specific Antigen Response Rate
Timepoint [5] 0 0
From baseline to PSA response (assessed up to December 2016, approximately 48 months)

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



* Prostate cancer with metastases
* Prostate cancer should be castration resistant
* Progression during hormonal therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Visceral metastases (eg liver, lung or brain metastases)
* Prior treatment with any immunotherapy for prostate cancer
* Prior or ongoing cytotoxic therapy for prostate cancer
* Autoimmune disease
* Inadequate hematologic, renal, or hepatic function

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 2
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
2/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/12/2016
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - St Leonards
Recruitment hospital [2] 0 0
Local Institution - Wahroonga
Recruitment hospital [3] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2076 - Wahroonga
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Chile
State/province [11] 0 0
Metropolitana
Country [12] 0 0
Chile
State/province [12] 0 0
Santiago DE Chile
Country [13] 0 0
Chile
State/province [13] 0 0
Valparaiso
Country [14] 0 0
France
State/province [14] 0 0
Clermont Ferrand cedex 01
Country [15] 0 0
France
State/province [15] 0 0
Marseille Cedex 9
Country [16] 0 0
France
State/province [16] 0 0
Poitiers
Country [17] 0 0
France
State/province [17] 0 0
Rennes Cedex
Country [18] 0 0
France
State/province [18] 0 0
Saint Herblain
Country [19] 0 0
France
State/province [19] 0 0
Villejuif
Country [20] 0 0
Germany
State/province [20] 0 0
Aachen
Country [21] 0 0
Germany
State/province [21] 0 0
Heidelberg
Country [22] 0 0
Germany
State/province [22] 0 0
Jena
Country [23] 0 0
Germany
State/province [23] 0 0
Magdeburg
Country [24] 0 0
Germany
State/province [24] 0 0
Mannheim
Country [25] 0 0
Germany
State/province [25] 0 0
Marktredwitz
Country [26] 0 0
Germany
State/province [26] 0 0
Muenchen
Country [27] 0 0
Germany
State/province [27] 0 0
Rostock
Country [28] 0 0
Germany
State/province [28] 0 0
Wesel
Country [29] 0 0
Germany
State/province [29] 0 0
Wuppertal
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Napoli
Country [32] 0 0
Netherlands
State/province [32] 0 0
Amsterdam
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Hospitalet de Llobregat - Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Sevilla
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Lanarkshire
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Nottinghamshire
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Surrey

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/NCT02279862