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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
9/10/2024

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
Active, not recruiting
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
6/10/2024
Actual
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
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United States of America
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Massachusetts
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Michigan
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Tucuman
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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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Alberta
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Ontario
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Quebec
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Czechia
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Hradec Kralove
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Ostrava-Poruba
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Praha 1
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Tampere
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Lille
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France
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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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Athens
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Hungary
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Bergamo
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Genova
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Italy
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Meldola (FC)
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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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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
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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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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
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taoyuan
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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
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
Trial website
https://clinicaltrials.gov/study/NCT02388906
Trial related presentations / publications
Larkin J, Weber J, Del Vecchio M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Middleton MR, De la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Long GV, Lobo M, Askelson M, Ascierto PA, Mandala M. Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria. Eur J Cancer. 2022 Sep;173:285-296. doi: 10.1016/j.ejca.2022.06.041. Epub 2022 Aug 11.
Weber JS, Ascierto PA, Middleton MR, Hennicken D, Zoffoli R, Pieters A, Amadi A, Kupas K, Kotapati S, Moshyk A, Schadendorf D. Indirect treatment comparison of nivolumab versus placebo as adjuvant treatment for resected melanoma. Eur J Cancer. 2021 Nov;158:225-233. doi: 10.1016/j.ejca.2021.08.028. Epub 2021 Oct 15.
Mandala M, Larkin J, Ascierto PA, Del Vecchio M, Gogas H, Cowey CL, Arance A, Dalle S, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Di Giacomo AM, Lutzky J, De La Cruz-Merino L, Atkinson V, Arenberger P, Hill A, Fecher L, Millward M, Khushalani NI, de Pril V, Lobo M, Weber J. Adjuvant nivolumab for stage III/IV melanoma: evaluation of safety outcomes and association with recurrence-free survival. J Immunother Cancer. 2021 Aug;9(8):e003188. doi: 10.1136/jitc-2021-003188. Erratum In: J Immunother Cancer. 2021 Nov;9(11):e003188corr1. doi: 10.1136/jitc-2021-003188corr1.
Ascierto PA, Del Vecchio M, Mandala M, Gogas H, Arance AM, Dalle S, Cowey CL, Schenker M, Grob JJ, Chiarion-Sileni V, Marquez-Rodas I, Butler MO, Maio M, Middleton MR, de la Cruz-Merino L, Arenberger P, Atkinson V, Hill A, Fecher LA, Millward M, Khushalani NI, Queirolo P, Lobo M, de Pril V, Loffredo J, Larkin J, Weber J. Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Nov;21(11):1465-1477. doi: 10.1016/S1470-2045(20)30494-0. Epub 2020 Sep 19. Erratum In: Lancet Oncol. 2021 Oct;22(10):e428. doi: 10.1016/S1470-2045(21)00537-4.
Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, Dalle S, Schenker M, Chiarion-Sileni V, Marquez-Rodas I, Grob JJ, Butler MO, Middleton MR, Maio M, Atkinson V, Queirolo P, Gonzalez R, Kudchadkar RR, Smylie M, Meyer N, Mortier L, Atkins MB, Long GV, Bhatia S, Lebbe C, Rutkowski P, Yokota K, Yamazaki N, Kim TM, de Pril V, Sabater J, Qureshi A, Larkin J, Ascierto PA; CheckMate 238 Collaborators. Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma. N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.
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/NCT02388906