Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00636168




Registration number
NCT00636168
Ethics application status
Date submitted
7/03/2008
Date registered
14/03/2008
Date last updated
17/12/2019

Titles & IDs
Public title
Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
Scientific title
Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-blind Phase 3 Trial of the EORTC Melanoma Group
Secondary ID [1] 0 0
EORTC 18071
Secondary ID [2] 0 0
CA184-029
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ipilimumab
Treatment: Drugs - Placebo

Active comparator: A -

Placebo comparator: B -


Treatment: Drugs: ipilimumab
IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal

Treatment: Drugs: Placebo
IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population
Timepoint [1] 0 0
Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.
Primary outcome [2] 0 0
Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population
Timepoint [2] 0 0
Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.
Primary outcome [3] 0 0
Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population
Timepoint [3] 0 0
At years 1, 2, and 3
Secondary outcome [1] 0 0
Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population
Timepoint [1] 0 0
From June 2008 to January 2016 (approximately 90 months)
Secondary outcome [2] 0 0
Number of Participants With Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population
Timepoint [2] 0 0
From June 2008 to January 2016 (approximately 90 months)
Secondary outcome [3] 0 0
Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population
Timepoint [3] 0 0
At years 1, 2, 3, 4 and 5
Secondary outcome [4] 0 0
Overall Survival in the Intent to Treat (ITT) Population
Timepoint [4] 0 0
From June 2008 to January 2016 (approximately 90 months)
Secondary outcome [5] 0 0
Rate of Overall Survival (OS)
Timepoint [5] 0 0
From date of randomization to date of death, assessed up to 9 years
Secondary outcome [6] 0 0
Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population
Timepoint [6] 0 0
Day 1 up to 70 days after last dose; up to 5 years
Secondary outcome [7] 0 0
Number of Participants With Serious Adverse Events (SAEs), Non-serious AEs (NSAEs) and Number of Deaths: Overall Study
Timepoint [7] 0 0
SAEs and NSAEs: Day 1 up to 70 days after last dose(safety window). Deaths: All deaths regardless of 70 day safety window.Up to 10 years
Secondary outcome [8] 0 0
Exposure Adjusted Incidence Rate of Adverse Events Including Multiple Occurrences of Unique Events
Timepoint [8] 0 0
Day 1 up to 70 days after last dose; up to 5 years
Secondary outcome [9] 0 0
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint
Timepoint [9] 0 0
Baseline up to 2 years from randomization

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



* Age = 18 years
* Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
* Disease-free
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
* Randomization within 12 weeks of surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy for melanoma except surgery
* Auto-immune 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 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
30/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/11/2018
Sample size
Target
Accrual to date
Final
1211
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Waratah
Recruitment hospital [2] 0 0
Local Institution - Westmead
Recruitment hospital [3] 0 0
Local Institution - Greenslopes
Recruitment hospital [4] 0 0
Local Institution - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - Box Hill
Recruitment hospital [6] 0 0
Local Institution - Malvern
Recruitment hospital [7] 0 0
Local Institution - Nedlands
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
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
Connecticut
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
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Austria
State/province [17] 0 0
Graz
Country [18] 0 0
Austria
State/province [18] 0 0
Wien
Country [19] 0 0
Belgium
State/province [19] 0 0
Gent
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 2
Country [24] 0 0
Denmark
State/province [24] 0 0
Aarhus C
Country [25] 0 0
Denmark
State/province [25] 0 0
Herlev
Country [26] 0 0
Denmark
State/province [26] 0 0
Odense C
Country [27] 0 0
Finland
State/province [27] 0 0
Helsinki
Country [28] 0 0
Finland
State/province [28] 0 0
Turku
Country [29] 0 0
France
State/province [29] 0 0
Cedex
Country [30] 0 0
France
State/province [30] 0 0
Boulogne-billancourt
Country [31] 0 0
France
State/province [31] 0 0
Marseille Cedex 5
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
France
State/province [33] 0 0
Pierre Benite
Country [34] 0 0
France
State/province [34] 0 0
Vandoeuvre Les Nancy
Country [35] 0 0
France
State/province [35] 0 0
Villejuif
Country [36] 0 0
Germany
State/province [36] 0 0
Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Essen
Country [38] 0 0
Germany
State/province [38] 0 0
Gottingen
Country [39] 0 0
Germany
State/province [39] 0 0
Heidelberg
Country [40] 0 0
Germany
State/province [40] 0 0
Kiel
Country [41] 0 0
Germany
State/province [41] 0 0
Koln
Country [42] 0 0
Germany
State/province [42] 0 0
Luebeck
Country [43] 0 0
Germany
State/province [43] 0 0
Mannheim
Country [44] 0 0
Germany
State/province [44] 0 0
Tubingen
Country [45] 0 0
Germany
State/province [45] 0 0
Wurzburg
Country [46] 0 0
Italy
State/province [46] 0 0
Genova
Country [47] 0 0
Italy
State/province [47] 0 0
Milano
Country [48] 0 0
Italy
State/province [48] 0 0
Napoli
Country [49] 0 0
Italy
State/province [49] 0 0
Padova
Country [50] 0 0
Italy
State/province [50] 0 0
Roma
Country [51] 0 0
Italy
State/province [51] 0 0
Siena
Country [52] 0 0
Netherlands
State/province [52] 0 0
Amsterdam
Country [53] 0 0
Netherlands
State/province [53] 0 0
Leiden
Country [54] 0 0
Netherlands
State/province [54] 0 0
Nijmegen
Country [55] 0 0
Netherlands
State/province [55] 0 0
Rotterdam
Country [56] 0 0
Norway
State/province [56] 0 0
Oslo
Country [57] 0 0
Poland
State/province [57] 0 0
Poznan
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Stavropol Region
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Ivanovo
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Izhevsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Krasnodar
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Krasnoyarsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Lipetsk
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Moscow
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Petrozavodsk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Saratov
Country [68] 0 0
Russian Federation
State/province [68] 0 0
St Petersburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
St. Petersburg
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Tomsk
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Ufa
Country [72] 0 0
Spain
State/province [72] 0 0
Barcelona
Country [73] 0 0
Spain
State/province [73] 0 0
Madrid
Country [74] 0 0
Spain
State/province [74] 0 0
Zaragoza
Country [75] 0 0
Sweden
State/province [75] 0 0
Stockholm
Country [76] 0 0
Switzerland
State/province [76] 0 0
Zurich
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Essex
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Greater London
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Hampshire
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Nottinghamshire
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Yorkshire

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/NCT00636168