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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Treatment: Drugs - Ipilimumab

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


Treatment: Drugs: Ipilimumab


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

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-free Survival (rPFS) - 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.
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) - The total number of participants with immune-related adverse events of any grade is reported for each arm.
Timepoint [1] 0 0
From first dose of ipilimumab to last dose plus 90 days
Secondary outcome [2] 0 0
Overall Survival (OS) - 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.
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) - 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.
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 - 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.
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 - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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 (Yervoyâ„¢) in patients with
metastatic castration resistant prostate cancer.
Trial website
https://clinicaltrials.gov/show/NCT02279862
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

Summary results
Other publications