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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
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Secondary ID [1]
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2019-001230-34
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Secondary ID [2]
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CA209-76K
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Universal Trial Number (UTN)
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Trial acronym
CheckMate76K
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Placebo
Experimental: Nivolumab -
Placebo Comparator: Placebo -
Other interventions: Nivolumab
Specified dose on specified days
Other interventions: Placebo
Specified dose on specified days
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recurrence Free Survival (RFS)
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Assessment method [1]
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Recurrence Free Survival (RFS) is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (whatever the cause), whichever occurs first. For participants who remain alive and whose disease has not recurred or did not die, RFS will be censored on the date of last evaluable disease assessment. For those participants who remained alive and had no recorded post-randomization tumor assessment, RFS will be censored on the day of randomization.
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Timepoint [1]
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From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)
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Secondary outcome [1]
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Distant Metastasis-Free Survival (DMFS)
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Assessment method [1]
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Investigator-assessed distant metastasis-free survival (DMFS) is defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. Participants with no baseline disease assessment, no on-study disease assessments and no death, and no distant metastasis and no death will be censored. Participants with no baseline disease assessment and no on-study disease assessments and death are censored on the date of randomization. Participants with no recurrence and no death will be censored on the date of their last evaluable disease assessment.
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Timepoint [1]
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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)
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Secondary outcome [2]
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Duration of Treatment on Next Line Therapy Per Investigator Assessment
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Assessment method [2]
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Duration of treatment is an investigator-assessed outcome of next-line therapy (NLT) defined as the time from first dose date of NLT to last dose date of NLT. Participants who did not stop the NLT were censored.
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Timepoint [2]
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From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months)
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Secondary outcome [3]
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Progression-Free Survival Through Next-Line Therapy
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Assessment method [3]
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Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first. Participants who did not receive subsequent systemic anti-cancer therapy who died will be considered as having the event on the date of death. Participants who received subsequent systemic anti-cancer therapy who had a disease progression after the start of therapy will be considered as having the event on the date of disease progression. Participants who died or started second next-line therapy, the date of death or start date of second next-line therapy will be the event date, whichever is earlier. Participants who did not experience disease progression, death, or second next-line therapy will be censored on the last known alive date.
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Timepoint [3]
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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)
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Secondary outcome [4]
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Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [4]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
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Timepoint [4]
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From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
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Secondary outcome [5]
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Number of Participants Experiencing Adverse Events Leading to Discontinuation
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Assessment method [5]
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An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
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Timepoint [5]
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From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
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Secondary outcome [6]
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Number of Participants Experiencing Select Adverse Events
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Assessment method [6]
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The number of participants experiencing all-cause select adverse events (AEs). An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
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Timepoint [6]
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From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
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Secondary outcome [7]
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Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [7]
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A Serious Adverse Events (SAE) is defined as any untoward or unfavorable medical occurrence in a participants that results in death, is life threatening, or places the participant at immediate risk of death from the event as it occurred, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or birth defects, and is another condition which investigators judge to represent significant hazards.
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Timepoint [7]
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From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
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Secondary outcome [8]
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Number of Participants Experiencing Death
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Assessment method [8]
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All study participants who died during the blinded phase of the study following treatment.
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Timepoint [8]
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From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
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Secondary outcome [9]
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Number of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities in Selected Hematology Parameters
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Assessment method [9]
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The number of participants experiencing Grade 3 or 4 laboratory abnormalities in the specific pre-determined hematology tests.
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Timepoint [9]
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From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
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Secondary outcome [10]
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Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters
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Assessment method [10]
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The number of participants experiencing laboratory abnormalities in the specific pre-determined liver tests.
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Timepoint [10]
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From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
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Secondary outcome [11]
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Overall Survival (OS)
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Assessment method [11]
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OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
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Timepoint [11]
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From randomization up to the date of death or the last date the participant was known to be alive
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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
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/06/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
790
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0018 - Waratah
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Recruitment hospital [2]
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Local Institution - 0025 - Westmead
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Recruitment hospital [3]
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Local Institution - 0016 - Wollstonecraft
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Recruitment hospital [4]
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Local Institution - 0105 - Cairns
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Recruitment hospital [5]
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Local Institution - 0017 - Greenslopes
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Recruitment hospital [6]
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Local Institution - 0024 - Herston
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Recruitment hospital [7]
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Local Institution - 0138 - Southport
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Recruitment hospital [8]
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Local Institution - 0019 - Box Hill
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Recruitment hospital [9]
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Local Institution - 0125 - Geelong
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Recruitment hospital [10]
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Local Institution - 0128 - Malvern
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Recruitment hospital [11]
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Local Institution - 0106 - Melbourne
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Recruitment hospital [12]
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Local Institution - 0104 - Nedlands
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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2065 - Wollstonecraft
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Recruitment postcode(s) [4]
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4870 - Cairns
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Recruitment postcode(s) [5]
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4120 - Greenslopes
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Recruitment postcode(s) [6]
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4029 - Herston
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Recruitment postcode(s) [7]
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4120 - Southport
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Recruitment postcode(s) [8]
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3128 - Box Hill
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Recruitment postcode(s) [9]
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3220 - Geelong
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Recruitment postcode(s) [10]
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3144 - Malvern
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Recruitment postcode(s) [11]
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3004 - Melbourne
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Recruitment postcode(s) [12]
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6009 - Nedlands
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Recruitment outside Australia
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Alabama
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Illinois
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Spain
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State/province [95]
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Santander
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Country [96]
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Spain
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State/province [96]
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Valencia
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Country [97]
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Sweden
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State/province [97]
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Orebro
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Country [98]
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0
Sweden
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State/province [98]
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0
Östergötlands Län [se-05]
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Country [99]
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Switzerland
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State/province [99]
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Lausanne
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Country [100]
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Switzerland
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State/province [100]
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Zuerich
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Country [101]
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United Kingdom
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State/province [101]
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Cardiff
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Country [102]
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United Kingdom
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State/province [102]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04099251
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04099251
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