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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
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Massachusetts
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United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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North Carolina
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United States of America
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Pennsylvania
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Tennessee
Country [14] 0 0
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Texas
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Utah
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United States of America
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Washington
Country [17] 0 0
Austria
State/province [17] 0 0
Graz
Country [18] 0 0
Austria
State/province [18] 0 0
Wien
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Belgium
State/province [19] 0 0
Gent
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Belgium
State/province [20] 0 0
Leuven
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Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
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Quebec
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Czechia
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Praha 2
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Denmark
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Aarhus C
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Denmark
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Herlev
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Denmark
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Odense C
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Finland
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Helsinki
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Finland
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Turku
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France
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Cedex
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France
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Boulogne-billancourt
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France
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Marseille Cedex 5
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France
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Paris
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France
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Pierre Benite
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France
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Vandoeuvre Les Nancy
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France
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Villejuif
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Germany
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Berlin
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Germany
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Essen
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Germany
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Gottingen
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Germany
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Heidelberg
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Germany
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Kiel
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Germany
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Koln
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Germany
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Luebeck
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Germany
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Mannheim
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Germany
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Tubingen
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Germany
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Wurzburg
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Italy
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Genova
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Italy
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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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Netherlands
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Amsterdam
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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Norway
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Oslo
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Poland
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Poznan
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Poland
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Warszawa
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Russian Federation
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Stavropol Region
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Russian Federation
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Ivanovo
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Russian Federation
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Izhevsk
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Russian Federation
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Krasnodar
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Lipetsk
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Russian Federation
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Moscow
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Russian Federation
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Petrozavodsk
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Russian Federation
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Saratov
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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Ufa
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Zaragoza
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Sweden
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Stockholm
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Switzerland
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Zurich
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United Kingdom
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Essex
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United Kingdom
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Greater London
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United Kingdom
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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