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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01515189




Registration number
NCT01515189
Ethics application status
Date submitted
18/01/2012
Date registered
24/01/2012
Date last updated
31/07/2019

Titles & IDs
Public title
Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
Scientific title
A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma
Secondary ID [1] 0 0
2011-004029-28
Secondary ID [2] 0 0
CA184-169
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Arm 1: Ipilimumab (3 mg/kg) - Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity

Experimental: Arm 2: Ipilimumab (10 mg/kg) - Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately 48 months (assessed up to February 2016)
Secondary outcome [1] 0 0
Progression Free Survival (PFS) by mWHO Criteria
Timepoint [1] 0 0
From date of randomization until 540 death events occurred (approximately 48 months)
Secondary outcome [2] 0 0
Best Overall Response Rate (BORR) by mWHO Criteria
Timepoint [2] 0 0
From date of randomization until 540 death events occurred (approximately 48 months)
Secondary outcome [3] 0 0
Disease Control Rate (DCR) by mWHO Criteria
Timepoint [3] 0 0
From date of randomization until 540 death events occurred (approximately 48 months)
Secondary outcome [4] 0 0
Duration of Response (DOR) by mWHO Criteria
Timepoint [4] 0 0
From date of randomization until 540 death events occurred (approximately 48 months)
Secondary outcome [5] 0 0
Duration of Stable Disease by mWHO Criteria
Timepoint [5] 0 0
From date of randomization until 540 death events occurred (approximately 48 months)
Secondary outcome [6] 0 0
Rate of Overall Survival
Timepoint [6] 0 0
Approximately 66 months
Secondary outcome [7] 0 0
Overall Survival of Participants With Brain Metastases at Baseline
Timepoint [7] 0 0
From date of randomization until 540 death events occurred (approximately 48 months)

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



* Unresectable Stage III or Stage IV melanoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Brain metastases with symptoms or requiring treatment
* History of autoimmune disease

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
17/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/08/2017
Sample size
Target
Accrual to date
Final
831
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [3] 0 0
Local Institution - Brisbane
Recruitment hospital [4] 0 0
Local Institution - Southport
Recruitment hospital [5] 0 0
Local Institution - Adelaide
Recruitment hospital [6] 0 0
Local Institution - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Argentina
State/province [9] 0 0
Tucuman
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Austria
State/province [11] 0 0
Linz
Country [12] 0 0
Austria
State/province [12] 0 0
Vienna
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Nova Scotia
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno
Country [19] 0 0
Czechia
State/province [19] 0 0
Olomouc
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha 2
Country [21] 0 0
Denmark
State/province [21] 0 0
Aarhus
Country [22] 0 0
Denmark
State/province [22] 0 0
Herlev
Country [23] 0 0
Denmark
State/province [23] 0 0
Odense
Country [24] 0 0
France
State/province [24] 0 0
Bordeaux
Country [25] 0 0
France
State/province [25] 0 0
Dijon Cedex
Country [26] 0 0
France
State/province [26] 0 0
Grenoble
Country [27] 0 0
France
State/province [27] 0 0
Lille
Country [28] 0 0
France
State/province [28] 0 0
Marseille Cedex 5
Country [29] 0 0
France
State/province [29] 0 0
Nantes Cedex 1
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Pierre Benite
Country [32] 0 0
France
State/province [32] 0 0
Reims Cedex
Country [33] 0 0
France
State/province [33] 0 0
Toulouse
Country [34] 0 0
France
State/province [34] 0 0
Villejuif
Country [35] 0 0
Germany
State/province [35] 0 0
Buxtehude
Country [36] 0 0
Germany
State/province [36] 0 0
Essen
Country [37] 0 0
Germany
State/province [37] 0 0
Hannover
Country [38] 0 0
Germany
State/province [38] 0 0
Heidelberg
Country [39] 0 0
Germany
State/province [39] 0 0
Kiel
Country [40] 0 0
Germany
State/province [40] 0 0
Mainz
Country [41] 0 0
Germany
State/province [41] 0 0
Munich
Country [42] 0 0
Germany
State/province [42] 0 0
Tubingen
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
Country [44] 0 0
Hungary
State/province [44] 0 0
Kaposvar
Country [45] 0 0
Hungary
State/province [45] 0 0
Szeged
Country [46] 0 0
Israel
State/province [46] 0 0
Jerusalem
Country [47] 0 0
Italy
State/province [47] 0 0
Meldola (fc)
Country [48] 0 0
Italy
State/province [48] 0 0
Milano
Country [49] 0 0
Italy
State/province [49] 0 0
Napoli
Country [50] 0 0
Italy
State/province [50] 0 0
Padova
Country [51] 0 0
Italy
State/province [51] 0 0
Roma
Country [52] 0 0
Italy
State/province [52] 0 0
Siena
Country [53] 0 0
Mexico
State/province [53] 0 0
Guanajuato
Country [54] 0 0
Netherlands
State/province [54] 0 0
Amsterdam
Country [55] 0 0
Netherlands
State/province [55] 0 0
Groningen
Country [56] 0 0
Netherlands
State/province [56] 0 0
Leiden
Country [57] 0 0
Norway
State/province [57] 0 0
Bergen
Country [58] 0 0
Norway
State/province [58] 0 0
Oslo
Country [59] 0 0
Poland
State/province [59] 0 0
Gdansk
Country [60] 0 0
Poland
State/province [60] 0 0
Poznan
Country [61] 0 0
Poland
State/province [61] 0 0
Warszawa
Country [62] 0 0
South Africa
State/province [62] 0 0
Western CAPE
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Navarra
Country [66] 0 0
Spain
State/province [66] 0 0
Valencia
Country [67] 0 0
Sweden
State/province [67] 0 0
Gothenberg
Country [68] 0 0
Sweden
State/province [68] 0 0
Lund
Country [69] 0 0
Sweden
State/province [69] 0 0
Stockholm
Country [70] 0 0
Sweden
State/province [70] 0 0
Umea
Country [71] 0 0
Switzerland
State/province [71] 0 0
Lausanne
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Greater Manchester
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Strathclyde
Country [74] 0 0
United Kingdom
State/province [74] 0 0
London
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Swansea

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/NCT01515189