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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04099251




Registration number
NCT04099251
Ethics application status
Date submitted
20/09/2019
Date registered
23/09/2019
Date last updated
14/11/2023

Titles & IDs
Public title
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Scientific title
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Secondary ID [1] 0 0
2019-001230-34
Secondary ID [2] 0 0
CA209-76K
Universal Trial Number (UTN)
Trial acronym
CheckMate76K
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

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Nivolumab
Other interventions - Placebo

Experimental: Nivolumab -

Placebo comparator: Placebo -


Treatment: Other: Nivolumab
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
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
From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)
Secondary outcome [1] 0 0
Distant Metastasis-Free Survival (DMFS)
Timepoint [1] 0 0
From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months)
Secondary outcome [2] 0 0
Duration of Treatment on Next Line Therapy Per Investigator Assessment
Timepoint [2] 0 0
From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)
Secondary outcome [3] 0 0
Progression-Free Survival Through Next-Line Therapy
Timepoint [3] 0 0
From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months)
Secondary outcome [4] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [4] 0 0
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary outcome [5] 0 0
Number of Participants Experiencing Adverse Events Leading to Discontinuation
Timepoint [5] 0 0
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary outcome [6] 0 0
Number of Participants Experiencing Select Adverse Events
Timepoint [6] 0 0
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary outcome [7] 0 0
Number of Participants Experiencing Serious Adverse Events (SAEs)
Timepoint [7] 0 0
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary outcome [8] 0 0
Number of Participants Experiencing Death
Timepoint [8] 0 0
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary outcome [9] 0 0
Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters
Timepoint [9] 0 0
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary outcome [10] 0 0
Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters
Timepoint [10] 0 0
From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
Secondary outcome [11] 0 0
Overall Survival (OS)
Timepoint [11] 0 0
From randomization up to the date of death or the last date the participant was known to be alive

Eligibility
Key inclusion criteria
* Had a negative sentinel lymph node biopsy
* Participant has not been previously treated for melanoma
* ECOG 0 or 1
* Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of ocular or mucosal melanoma.
* Pregnant or nursing women
* Participants with active known or suspected autoimmune disease
* Known history of allergy or hypersensitivity to study drug components
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways

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 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
28/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/06/2027
Actual
Sample size
Target
Accrual to date
Final
790
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0018 - Waratah
Recruitment hospital [2] 0 0
Local Institution - 0025 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0016 - Wollstonecraft
Recruitment hospital [4] 0 0
Local Institution - 0105 - Cairns
Recruitment hospital [5] 0 0
Local Institution - 0017 - Greenslopes
Recruitment hospital [6] 0 0
Local Institution - 0024 - Herston
Recruitment hospital [7] 0 0
Local Institution - 0138 - Southport
Recruitment hospital [8] 0 0
Local Institution - 0019 - Box Hill
Recruitment hospital [9] 0 0
Local Institution - 0125 - Geelong
Recruitment hospital [10] 0 0
Local Institution - 0128 - Malvern
Recruitment hospital [11] 0 0
Local Institution - 0106 - Melbourne
Recruitment hospital [12] 0 0
Local Institution - 0104 - Nedlands
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4120 - Southport
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
3144 - Malvern
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
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
Nebraska
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
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Austria
State/province [22] 0 0
Graz
Country [23] 0 0
Austria
State/province [23] 0 0
Innsbruck
Country [24] 0 0
Austria
State/province [24] 0 0
Salzburg
Country [25] 0 0
Austria
State/province [25] 0 0
Wien
Country [26] 0 0
Belgium
State/province [26] 0 0
Charleroi
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
State/province [28] 0 0
Kortrijk
Country [29] 0 0
Belgium
State/province [29] 0 0
Liège
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Nova Scotia
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Czechia
State/province [35] 0 0
Praha 2
Country [36] 0 0
Czechia
State/province [36] 0 0
Ostrava-Poruba
Country [37] 0 0
Czechia
State/province [37] 0 0
Praha 10
Country [38] 0 0
Denmark
State/province [38] 0 0
Aarhus N
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Denmark
State/province [39] 0 0
Herlev
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Denmark
State/province [40] 0 0
Odense
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Finland
State/province [41] 0 0
Etelä-Suomen Lääni
Country [42] 0 0
Finland
State/province [42] 0 0
Pirkanmaa
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Finland
State/province [43] 0 0
Turku
Country [44] 0 0
France
State/province [44] 0 0
Finistère
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France
State/province [45] 0 0
Besancon Cedex
Country [46] 0 0
France
State/province [46] 0 0
Bordeaux
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France
State/province [47] 0 0
Lille
Country [48] 0 0
France
State/province [48] 0 0
Marseille
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France
State/province [49] 0 0
Nantes
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France
State/province [50] 0 0
Nice
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France
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Paris
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France
State/province [52] 0 0
Pierre Benite Cedex
Country [53] 0 0
France
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Villejuif
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Germany
State/province [54] 0 0
Bayern
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Germany
State/province [55] 0 0
Bonn
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Germany
State/province [56] 0 0
Buxtehude
Country [57] 0 0
Germany
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Dresden
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Germany
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Essen
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Germany
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Gera
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Germany
State/province [60] 0 0
Goettingen
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Lubeck
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Germany
State/province [64] 0 0
Mainz
Country [65] 0 0
Germany
State/province [65] 0 0
Regensburg
Country [66] 0 0
Germany
State/province [66] 0 0
Tuebingen
Country [67] 0 0
Greece
State/province [67] 0 0
Athina
Country [68] 0 0
Greece
State/province [68] 0 0
Piraeus
Country [69] 0 0
Greece
State/province [69] 0 0
Thessaloniki
Country [70] 0 0
Italy
State/province [70] 0 0
Sicilia
Country [71] 0 0
Italy
State/province [71] 0 0
Bergamo
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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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Perugia
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Italy
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Siena
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Netherlands
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Breda
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Netherlands
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Groningen
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Norway
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Bergen
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Norway
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Gralum
Country [83] 0 0
Norway
State/province [83] 0 0
Oslo
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Poland
State/province [84] 0 0
Wielkopolskie
Country [85] 0 0
Poland
State/province [85] 0 0
Gdansk
Country [86] 0 0
Poland
State/province [86] 0 0
Warszawa
Country [87] 0 0
Romania
State/province [87] 0 0
Cluj-Napoca
Country [88] 0 0
Romania
State/province [88] 0 0
Craiova
Country [89] 0 0
Romania
State/province [89] 0 0
Sector 2
Country [90] 0 0
Spain
State/province [90] 0 0
A Coruña
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Spain
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Badalona
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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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Malaga
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Spain
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Santander
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Spain
State/province [96] 0 0
Valencia
Country [97] 0 0
Sweden
State/province [97] 0 0
Orebro
Country [98] 0 0
Sweden
State/province [98] 0 0
Östergötlands Län [se-05]
Country [99] 0 0
Switzerland
State/province [99] 0 0
Lausanne
Country [100] 0 0
Switzerland
State/province [100] 0 0
Zuerich
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Cardiff
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Southampton

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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04099251