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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
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Arizona
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Arkansas
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United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
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Colorado
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District of Columbia
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Georgia
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Illinois
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Maryland
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Massachusetts
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Minnesota
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Nebraska
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New Jersey
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New York
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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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Austria
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Graz
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Austria
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Innsbruck
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Salzburg
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Wien
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Charleroi
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Gent
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Kortrijk
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Liège
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Lille
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Pierre Benite Cedex
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Bayern
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Bonn
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Buxtehude
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Essen
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Gera
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Heidelberg
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Lubeck
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Mainz
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Regensburg
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Tuebingen
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Athina
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Piraeus
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Gdansk
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Warszawa
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Sector 2
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Spain
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A Coruña
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Badalona
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Barcelona
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Malaga
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Santander
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Valencia
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Sweden
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Orebro
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Sweden
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Östergötlands Län [se-05]
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Switzerland
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Lausanne
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Switzerland
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Zuerich
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Cardiff
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United Kingdom
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
Trial website
https://clinicaltrials.gov/study/NCT04099251
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04099251