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/show/NCT02388906




Registration number
NCT02388906
Ethics application status
Date submitted
10/03/2015
Date registered
17/03/2015
Date last updated
13/11/2019

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 (CheckMate 238)
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
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 - Ipilimumab IV infusion and Placebo as specified

Experimental: Nivolumab and Placebo matching Ipilimumab - Nivolumab IV infusion and Placebo as specified


Treatment: Drugs: Ipilimumab


Treatment: Drugs: Nivolumab


Other interventions: Placebo matching Ipilimumab


Other interventions: Placebo matching Nivolumab


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
Timepoint [1] 0 0
Upto 36 months
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Upto 48 months

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



- 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
Gender
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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Gateshead
Recruitment hospital [2] 0 0
Local Institution - North Sydney
Recruitment hospital [3] 0 0
Local Institution - Westmead
Recruitment hospital [4] 0 0
Local Institution - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - Southport
Recruitment hospital [6] 0 0
Local Institution - Adelaide
Recruitment hospital [7] 0 0
Local Institution - Heidelberg
Recruitment hospital [8] 0 0
Local Institution - Prahran
Recruitment hospital [9] 0 0
Local Institution - Nedlands
Recruitment hospital [10] 0 0
Local Institution - Camperdown
Recruitment postcode(s) [1] 0 0
2290 - Gateshead
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
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
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Tucuman
Country [26] 0 0
Argentina
State/province [26] 0 0
Cordoba
Country [27] 0 0
Austria
State/province [27] 0 0
Graz
Country [28] 0 0
Austria
State/province [28] 0 0
Salzburg
Country [29] 0 0
Belgium
State/province [29] 0 0
Brussels
Country [30] 0 0
Belgium
State/province [30] 0 0
Bruxelles
Country [31] 0 0
Belgium
State/province [31] 0 0
Gent
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Czechia
State/province [37] 0 0
Hradec Kralove
Country [38] 0 0
Czechia
State/province [38] 0 0
Ostrava-Poruba
Country [39] 0 0
Czechia
State/province [39] 0 0
Praha 10
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 2
Country [41] 0 0
Finland
State/province [41] 0 0
Helsinki
Country [42] 0 0
Finland
State/province [42] 0 0
Tampere
Country [43] 0 0
France
State/province [43] 0 0
Lille
Country [44] 0 0
France
State/province [44] 0 0
Marseille Cedex 5
Country [45] 0 0
France
State/province [45] 0 0
Nantes Cedex 1
Country [46] 0 0
France
State/province [46] 0 0
Paris
Country [47] 0 0
France
State/province [47] 0 0
Pierre Benite
Country [48] 0 0
France
State/province [48] 0 0
Toulouse Cedex 9
Country [49] 0 0
Greece
State/province [49] 0 0
Athens
Country [50] 0 0
Greece
State/province [50] 0 0
Neo Faliro
Country [51] 0 0
Hungary
State/province [51] 0 0
Budapest
Country [52] 0 0
Ireland
State/province [52] 0 0
Dublin 7
Country [53] 0 0
Ireland
State/province [53] 0 0
Dublin
Country [54] 0 0
Ireland
State/province [54] 0 0
Galway
Country [55] 0 0
Italy
State/province [55] 0 0
Bergamo
Country [56] 0 0
Italy
State/province [56] 0 0
Genova
Country [57] 0 0
Italy
State/province [57] 0 0
Meldola (FC)
Country [58] 0 0
Italy
State/province [58] 0 0
Milano
Country [59] 0 0
Italy
State/province [59] 0 0
Napoli
Country [60] 0 0
Italy
State/province [60] 0 0
Padova
Country [61] 0 0
Italy
State/province [61] 0 0
Roma
Country [62] 0 0
Italy
State/province [62] 0 0
Siena
Country [63] 0 0
Japan
State/province [63] 0 0
Aichi
Country [64] 0 0
Japan
State/province [64] 0 0
Fukuoka
Country [65] 0 0
Japan
State/province [65] 0 0
Ibaraki
Country [66] 0 0
Japan
State/province [66] 0 0
Kumamoto
Country [67] 0 0
Japan
State/province [67] 0 0
Nagano
Country [68] 0 0
Japan
State/province [68] 0 0
Niigata
Country [69] 0 0
Japan
State/province [69] 0 0
Osaka
Country [70] 0 0
Japan
State/province [70] 0 0
Shizuoka
Country [71] 0 0
Japan
State/province [71] 0 0
Tokyo
Country [72] 0 0
Japan
State/province [72] 0 0
Yamanashi
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Seoul
Country [74] 0 0
Netherlands
State/province [74] 0 0
Amsterdam
Country [75] 0 0
Netherlands
State/province [75] 0 0
Groningen
Country [76] 0 0
Netherlands
State/province [76] 0 0
Nijmegen
Country [77] 0 0
Netherlands
State/province [77] 0 0
Veldhoven
Country [78] 0 0
Norway
State/province [78] 0 0
Bergen
Country [79] 0 0
Norway
State/province [79] 0 0
Oslo
Country [80] 0 0
Poland
State/province [80] 0 0
Gdansk
Country [81] 0 0
Poland
State/province [81] 0 0
Krakow
Country [82] 0 0
Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Romania
State/province [83] 0 0
Craiova
Country [84] 0 0
Romania
State/province [84] 0 0
Romania
Country [85] 0 0
South Africa
State/province [85] 0 0
Gauteng
Country [86] 0 0
South Africa
State/province [86] 0 0
Western CAPE
Country [87] 0 0
Spain
State/province [87] 0 0
Barcelona
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Sevilla
Country [90] 0 0
Spain
State/province [90] 0 0
Valencia
Country [91] 0 0
Sweden
State/province [91] 0 0
Gothenberg
Country [92] 0 0
Sweden
State/province [92] 0 0
Lund
Country [93] 0 0
Switzerland
State/province [93] 0 0
Zurich
Country [94] 0 0
Taiwan
State/province [94] 0 0
Kaohsiung
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taichung
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taoyuan
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Avon
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Carmarthenshire
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Greater London
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Greater Manchester
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Hampshire
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Middlesex
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Oxfordshire
Country [104] 0 0
United Kingdom
State/province [104] 0 0
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/show/NCT02388906
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

Summary results
Other publications