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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02388906




Registration number
NCT02388906
Ethics application status
Date submitted
10/03/2015
Date registered
17/03/2015
Date last updated
4/12/2024

Titles & IDs
Public title
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
Scientific title
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)
Secondary ID [1] 0 0
2014-002351-26
Secondary ID [2] 0 0
CA209-238
Universal Trial Number (UTN)
Trial acronym
CheckMate 238
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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Nivolumab
Other interventions - Placebo matching Ipilimumab
Other interventions - Placebo matching Nivolumab

Experimental: Ipilimumab and Placebo matching Nivolumab -

Experimental: Nivolumab and Placebo matching Ipilimumab -


Treatment: Drugs: Ipilimumab
Specified dose on specified days

Treatment: Drugs: Nivolumab
Specified dose on specified days

Other interventions: Placebo matching Ipilimumab
Specified dose on specified days

Other interventions: Placebo matching Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence-free Survival (RFS)
Timepoint [1] 0 0
up to 36 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
up to 60 months
Secondary outcome [2] 0 0
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events
Timepoint [2] 0 0
reported between first dose and 30 days after last dose of study therapy
Secondary outcome [3] 0 0
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events
Timepoint [3] 0 0
reported between the first dose and 30 days after last dose of study therapy
Secondary outcome [4] 0 0
the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths
Timepoint [4] 0 0
reported between first dose and 30 to 100 days after last dose of study therapy
Secondary outcome [5] 0 0
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
Timepoint [5] 0 0
reported after first dose and within 30 days of last dose of the study therapy
Secondary outcome [6] 0 0
Recurrence-free Survival by PD-L1 Expression
Timepoint [6] 0 0
up to 36 months
Secondary outcome [7] 0 0
Health Related Quality of Life (HRQoL) Evaluation
Timepoint [7] 0 0
up to 36 months

Eligibility
Key inclusion criteria
* At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is = 18 years of age
* Completely removed melanoma by surgery performed within 12 weeks of randomization
* Stage IIIb/C or Stage IV before complete resection
* No previous anti-cancer treatment
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Ocular or uveal melanoma
* History of carcinomatosis meningitis
* History of auto-immune disease
* Treatment directed against the resected melanoma that is administrated after the surgery

Other protocol-defined inclusion/exclusion criteria apply

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
16/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/10/2024
Sample size
Target
Accrual to date
Final
906
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0079 - Gateshead
Recruitment hospital [2] 0 0
Local Institution - 0080 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0078 - Wollstonecraft
Recruitment hospital [4] 0 0
Local Institution - 0082 - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - 0083 - Southport
Recruitment hospital [6] 0 0
Local Institution - 0084 - Adelaide
Recruitment hospital [7] 0 0
Local Institution - 0075 - Heidelberg
Recruitment hospital [8] 0 0
Local Institution - 0077 - Prahran
Recruitment hospital [9] 0 0
Local Institution - 0085 - Nedlands
Recruitment hospital [10] 0 0
Local Institution - 0081 - Camperdown
Recruitment postcode(s) [1] 0 0
2290 - Gateshead
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3181 - Prahran
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
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United States of America
State/province [9] 0 0
Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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New Jersey
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New York
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Tucuman
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Argentina
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Cordoba
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Austria
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Graz
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Austria
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Salzburg
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Hradec Kralove
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Czechia
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Ostrava-Poruba
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Czechia
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Praha 1
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Czechia
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Praha 2
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Finland
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Helsinki
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Finland
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Tampere
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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
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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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Toulouse
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Greece
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Athens
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Greece
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Neo Faliro
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Hungary
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Budapest
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Ireland
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Dublin 7
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Ireland
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Dublin
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Ireland
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Galway
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Italy
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Bergamo
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Italy
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Genova
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Italy
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Meldola (FC)
Country [57] 0 0
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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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Ibaraki
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Japan
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Kumamoto
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Japan
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Nagano
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Yamanashi
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Korea, Republic of
State/province [72] 0 0
Seoul
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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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Nijmegen
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Netherlands
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Veldhoven
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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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Krakow
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Poland
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Warszawa
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Romania
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Craiova
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Romania
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Romania
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South Africa
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Gauteng
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South Africa
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Western CAPE
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South Africa
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Western Cape
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Spain
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Barcelona
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Spain
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Madrid
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Sevilla
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Spain
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Valencia
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Sweden
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Gothenberg
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Sweden
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Lund
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Switzerland
State/province [93] 0 0
Zuerich
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Taiwan
State/province [94] 0 0
Kaohsiung
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Taiwan
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Taichung
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Taiwan
State/province [96] 0 0
Taoyuan
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Avon
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United Kingdom
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Carmarthenshire
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United Kingdom
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Greater London
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United Kingdom
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Greater Manchester
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United Kingdom
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Hampshire
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United Kingdom
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Middlesex
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United Kingdom
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Oxfordshire
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United Kingdom
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Tyne And Wear
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Leicester
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02388906