Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
2011-004029-28
Query!
Secondary ID [2]
0
0
CA184-169
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Melanoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.
Query!
Timepoint [1]
0
0
Approximately 48 months (assessed up to February 2016)
Query!
Secondary outcome [1]
0
0
Progression Free Survival (PFS) by mWHO Criteria
Query!
Assessment method [1]
0
0
PFS was defined as the time between randomization date and the date of progression or death, whichever occurred first. A participant who died without reported prior progression was considered to have progressed on the date of death. For a participant who underwent resection post randomization, PFS was censored on last tumor assessment date prior to resection. For those who remained alive and had not progressed, PFS was censored on last evaluable tumor assessment date. Participants who had not died and had no recorded post-baseline tumor assessment were censored at the day of randomization. For participants who had Progressive Disease (PD) prior to Week 12 and a subsequent assessment of Stable Disease (SD), Partial Response (PR), or Complete Response (CR), the date of PD following response was used in the analysis of PFS; otherwise these participants were censored on the date of their last tumor assessment. Median and 2-sided 95% CIs were calculated with Brookmeyer Crowley method.
Query!
Timepoint [1]
0
0
From date of randomization until 540 death events occurred (approximately 48 months)
Query!
Secondary outcome [2]
0
0
Best Overall Response Rate (BORR) by mWHO Criteria
Query!
Assessment method [2]
0
0
BORR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR or PR, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for BOR, e.g. on account of missing or "not evaluable" assessments, was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the BORR endpoint). 95% 2-sided exact confidence intervals were computed using the method of Clopper and Pearson.
Query!
Timepoint [2]
0
0
From date of randomization until 540 death events occurred (approximately 48 months)
Query!
Secondary outcome [3]
0
0
Disease Control Rate (DCR) by mWHO Criteria
Query!
Assessment method [3]
0
0
DCR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR, PR or SD, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for Disease Control (DC), (e.g. on account of missing or "not evaluable" assessments), was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the DCR endpoint). 95% 2-sided exact confidence intervals were computed using the Clopper and Pearson method.
Query!
Timepoint [3]
0
0
From date of randomization until 540 death events occurred (approximately 48 months)
Query!
Secondary outcome [4]
0
0
Duration of Response (DOR) by mWHO Criteria
Query!
Assessment method [4]
0
0
Duration of response for participants whose BOR was CR or PR was defined as the time between the date measurement criteria were first met for overall response of PR or CR (whichever status was recorded first) and the date of disease progression or death (whichever occurred first). For participants who underwent tumor resection following response but prior to disease progression, duration of response was censored on the date of last evaluable tumor assessment prior to resection. For participants who had BOR of SD, PR or CR at Week 12, or a confirmed response of PR or CR before Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of response. For those participants who remained alive and had not progressed following response, duration of response was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer Crowley method.
Query!
Timepoint [4]
0
0
From date of randomization until 540 death events occurred (approximately 48 months)
Query!
Secondary outcome [5]
0
0
Duration of Stable Disease by mWHO Criteria
Query!
Assessment method [5]
0
0
Duration of stable disease was defined for participants whose BOR was SD as the time between when SD was first documented and the date of PD or death (whichever occurred first). For a participant who underwent tumor resection following Week 12 but prior to disease progression, duration of stable disease was censored on the date of the last evaluable tumor assessment prior to resection. For participants who had BOR of SD at Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of stable disease. For participants with BOR of SD who had not subsequently progressed and who remained alive, duration of stable disease was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.
Query!
Timepoint [5]
0
0
From date of randomization until 540 death events occurred (approximately 48 months)
Query!
Secondary outcome [6]
0
0
Rate of Overall Survival
Query!
Assessment method [6]
0
0
OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Survival rates were calculated based on Kaplan-Meier estimation with log-log transformed confidence intervals. The survival rate at x year(s) is defined as the probability that a subject is alive at x year(s) following randomization.
Query!
Timepoint [6]
0
0
Approximately 66 months
Query!
Secondary outcome [7]
0
0
Overall Survival of Participants With Brain Metastases at Baseline
Query!
Assessment method [7]
0
0
OS for each participant with brain metastases at baseline was measured as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median OS, and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.
Query!
Timepoint [7]
0
0
From date of randomization until 540 death events occurred (approximately 48 months)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Brain metastases with symptoms or requiring treatment
* History of autoimmune disease
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/02/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
17/08/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
831
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - Camperdown
Query!
Recruitment hospital [2]
0
0
Local Institution - Coffs Harbour
Query!
Recruitment hospital [3]
0
0
Local Institution - Brisbane
Query!
Recruitment hospital [4]
0
0
Local Institution - Southport
Query!
Recruitment hospital [5]
0
0
Local Institution - Adelaide
Query!
Recruitment hospital [6]
0
0
Local Institution - Heidelberg
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [3]
0
0
4102 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [5]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [6]
0
0
3084 - Heidelberg
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New York
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
North Carolina
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Oregon
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Washington
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Tucuman
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Buenos Aires
Query!
Country [11]
0
0
Austria
Query!
State/province [11]
0
0
Linz
Query!
Country [12]
0
0
Austria
Query!
State/province [12]
0
0
Vienna
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Bruxelles
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Leuven
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Alberta
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Nova Scotia
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Quebec
Query!
Country [18]
0
0
Czechia
Query!
State/province [18]
0
0
Brno
Query!
Country [19]
0
0
Czechia
Query!
State/province [19]
0
0
Olomouc
Query!
Country [20]
0
0
Czechia
Query!
State/province [20]
0
0
Praha 2
Query!
Country [21]
0
0
Denmark
Query!
State/province [21]
0
0
Aarhus
Query!
Country [22]
0
0
Denmark
Query!
State/province [22]
0
0
Herlev
Query!
Country [23]
0
0
Denmark
Query!
State/province [23]
0
0
Odense
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Bordeaux
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Dijon Cedex
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Grenoble
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Lille
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Marseille Cedex 5
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Nantes Cedex 1
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Paris
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Pierre Benite
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Reims Cedex
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Toulouse
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Villejuif
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Buxtehude
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Essen
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Hannover
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Heidelberg
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Kiel
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Mainz
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Munich
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Tubingen
Query!
Country [43]
0
0
Hungary
Query!
State/province [43]
0
0
Budapest
Query!
Country [44]
0
0
Hungary
Query!
State/province [44]
0
0
Kaposvar
Query!
Country [45]
0
0
Hungary
Query!
State/province [45]
0
0
Szeged
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Jerusalem
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Meldola (fc)
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Milano
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Napoli
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Padova
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Roma
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Siena
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Guanajuato
Query!
Country [54]
0
0
Netherlands
Query!
State/province [54]
0
0
Amsterdam
Query!
Country [55]
0
0
Netherlands
Query!
State/province [55]
0
0
Groningen
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Leiden
Query!
Country [57]
0
0
Norway
Query!
State/province [57]
0
0
Bergen
Query!
Country [58]
0
0
Norway
Query!
State/province [58]
0
0
Oslo
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Gdansk
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Poznan
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Warszawa
Query!
Country [62]
0
0
South Africa
Query!
State/province [62]
0
0
Western CAPE
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Barcelona
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Madrid
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Navarra
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Valencia
Query!
Country [67]
0
0
Sweden
Query!
State/province [67]
0
0
Gothenberg
Query!
Country [68]
0
0
Sweden
Query!
State/province [68]
0
0
Lund
Query!
Country [69]
0
0
Sweden
Query!
State/province [69]
0
0
Stockholm
Query!
Country [70]
0
0
Sweden
Query!
State/province [70]
0
0
Umea
Query!
Country [71]
0
0
Switzerland
Query!
State/province [71]
0
0
Lausanne
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
Greater Manchester
Query!
Country [73]
0
0
United Kingdom
Query!
State/province [73]
0
0
Strathclyde
Query!
Country [74]
0
0
United Kingdom
Query!
State/province [74]
0
0
London
Query!
Country [75]
0
0
United Kingdom
Query!
State/province [75]
0
0
Swansea
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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
Query!
Trial website
https://clinicaltrials.gov/study/NCT01515189
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
Download to PDF