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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
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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
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Secondary ID [1]
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2014-002987-34
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Secondary ID [2]
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CA184-437
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiographic Progression-free Survival (rPFS)
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Assessment method [1]
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rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown.
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Timepoint [1]
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From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)
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Secondary outcome [1]
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Number of Participants Who Experienced Immune-related Adverse Events (irAEs)
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Assessment method [1]
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The total number of participants with immune-related adverse events of any grade is reported for each arm.
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Timepoint [1]
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From first dose of ipilimumab to last dose plus 90 days
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored at the last date the participant was known to be alive. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The total number of reported deaths is shown.
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Timepoint [2]
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From randomization to death from any cause (assessed up to December 2016, approximately 24 months)
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Secondary outcome [3]
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Prostate Specific Antigen Progression-free Survival (PSA PFS)
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Assessment method [3]
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Prostate specific antigen progression-free survival (PSA PFS) was defined as the time from randomization to the earliest date of PSA progression or death, whichever occurs earlier. Participants who did not progress or die were censored at the last PSA assessment date. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported PSA progression is shown.
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Timepoint [3]
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From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)
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Secondary outcome [4]
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Time to Pain Progression
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Assessment method [4]
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Pain progression was defined as an increase in BPI-SF pain Item #3 score of \>= 2 point from baseline maintained over 2 consecutive periods. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment, and presented efficacy results are based on limited data. The number of participants with reported pain progression is shown.
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Timepoint [4]
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From randomization until pain progression (assessed up to December 2016, approximately 24 months)
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Secondary outcome [5]
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Prostate Specific Antigen Response Rate
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Assessment method [5]
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PSA response rate was defined as the proportion of participants with a 50% or greater decrease from baseline to the lowest post-baseline PSA result (confirmed 3 weeks later) for each randomized arm. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants showing PSA response is shown.
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Timepoint [5]
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From baseline to PSA response (assessed up to December 2016, approximately 48 months)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/12/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/12/2016
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Sample size
Target
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Accrual to date
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Final
82
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Local Institution - St Leonards
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Recruitment hospital [2]
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Local Institution - Wahroonga
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Recruitment hospital [3]
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Local Institution - Parkville
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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2076 - Wahroonga
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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California
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United States of America
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District of Columbia
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Florida
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Kansas
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Mississippi
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Nebraska
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Oregon
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Texas
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Virginia
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Chile
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Metropolitana
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Chile
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Santiago DE Chile
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Chile
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Valparaiso
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France
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Clermont Ferrand cedex 01
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France
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Marseille Cedex 9
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France
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Poitiers
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France
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Rennes Cedex
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France
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Saint Herblain
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France
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Villejuif
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Aachen
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Heidelberg
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Jena
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Germany
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Marktredwitz
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Germany
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Muenchen
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Germany
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Rostock
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Germany
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Wesel
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Germany
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Wuppertal
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Milano
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Amsterdam
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Barcelona
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Spain
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Hospitalet de Llobregat - Barcelona
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Spain
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Sevilla
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Spain
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Valencia
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Lanarkshire
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Nottinghamshire
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United Kingdom
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.
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Trial website
https://clinicaltrials.gov/study/NCT02279862
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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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
Download to PDF