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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
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Illinois
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Washington
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Argentina
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Tucuman
Country [10] 0 0
Argentina
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Buenos Aires
Country [11] 0 0
Austria
State/province [11] 0 0
Linz
Country [12] 0 0
Austria
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Vienna
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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
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Czechia
State/province [18] 0 0
Brno
Country [19] 0 0
Czechia
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Olomouc
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Czechia
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Praha 2
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Denmark
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Aarhus
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Denmark
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Herlev
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Denmark
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Odense
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France
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Bordeaux
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France
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Dijon Cedex
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France
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Grenoble
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France
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Lille
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France
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Marseille Cedex 5
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France
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Nantes Cedex 1
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France
State/province [30] 0 0
Paris
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France
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Pierre Benite
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France
State/province [32] 0 0
Reims Cedex
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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
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Germany
State/province [36] 0 0
Essen
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Germany
State/province [37] 0 0
Hannover
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Germany
State/province [38] 0 0
Heidelberg
Country [39] 0 0
Germany
State/province [39] 0 0
Kiel
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Germany
State/province [40] 0 0
Mainz
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Germany
State/province [41] 0 0
Munich
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Germany
State/province [42] 0 0
Tubingen
Country [43] 0 0
Hungary
State/province [43] 0 0
Budapest
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Hungary
State/province [44] 0 0
Kaposvar
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Hungary
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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
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Italy
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Napoli
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Italy
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Padova
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Italy
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Roma
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Italy
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Siena
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Mexico
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Guanajuato
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Leiden
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Norway
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Bergen
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Norway
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Oslo
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Poland
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Gdansk
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Poland
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Poznan
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Poland
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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
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Spain
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Madrid
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Spain
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Navarra
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Spain
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Valencia
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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
The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg
Trial website
https://clinicaltrials.gov/study/NCT01515189
Trial related presentations / publications
Ascierto PA, Del Vecchio M, Mackiewicz A, Robert C, Chiarion-Sileni V, Arance A, Lebbe C, Svane IM, McNeil C, Rutkowski P, Loquai C, Mortier L, Hamid O, Bastholt L, Dreno B, Schadendorf D, Garbe C, Nyakas M, Grob JJ, Thomas L, Liszkay G, Smylie M, Hoeller C, Ferraresi V, Grange F, Gutzmer R, Pikiel J, Hosein F, Simsek B, Maio M. Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma. J Immunother Cancer. 2020 Jun;8(1):e000391. doi: 10.1136/jitc-2019-000391. Erratum In: J Immunother Cancer. 2020 Jul;8(2):e000391corr1. doi: 10.1136/jitc-2019-000391corr1.
Feng Y, Wang X, Suryawanshi S, Bello A, Roy A. Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling. CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):825-834. doi: 10.1002/psp4.12454. Epub 2019 Aug 13.
Ascierto PA, Del Vecchio M, Robert C, Mackiewicz A, Chiarion-Sileni V, Arance A, Lebbe C, Bastholt L, Hamid O, Rutkowski P, McNeil C, Garbe C, Loquai C, Dreno B, Thomas L, Grob JJ, Liszkay G, Nyakas M, Gutzmer R, Pikiel J, Grange F, Hoeller C, Ferraresi V, Smylie M, Schadendorf D, Mortier L, Svane IM, Hennicken D, Qureshi A, Maio M. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2017 May;18(5):611-622. doi: 10.1016/S1470-2045(17)30231-0. Epub 2017 Mar 27.
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/NCT01515189