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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/NCT02388906
Registration number
NCT02388906
Ethics application status
Date submitted
10/03/2015
Date registered
17/03/2015
Date last updated
10/01/2024
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
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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)
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Secondary ID [1]
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2014-002351-26
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Secondary ID [2]
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CA209-238
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 238
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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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Malignant melanoma
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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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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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, or death (whatever the cause), whichever occurs first.
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Timepoint [1]
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up to 36 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as as the time between the date of randomization and the date of death.
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Timepoint [1]
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up to 60 months
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Secondary outcome [2]
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The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events
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Assessment method [2]
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the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events
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Timepoint [2]
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reported between first dose and 30 days after last dose of study therapy
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Secondary outcome [3]
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The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events
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Assessment method [3]
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The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events
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Timepoint [3]
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reported between the first dose and 30 days after last dose of study therapy
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Secondary outcome [4]
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the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths
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Assessment method [4]
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the safety and tolerability of Nivolumab and Ipilimumab wasmeasured by the incidence of Deaths
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Timepoint [4]
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reported between first dose and 30 to 100 days after last dose of study therapy
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Secondary outcome [5]
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The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities
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Assessment method [5]
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The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.
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Timepoint [5]
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reported after first dose and within 30 days of last dose of the study therapy
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Secondary outcome [6]
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Recurrence-free Survival by PD-L1 Expression
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Assessment method [6]
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Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)
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Timepoint [6]
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up to 36 months
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Secondary outcome [7]
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Health Related Quality of Life (HRQoL) Evaluation
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Assessment method [7]
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HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants.
EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.
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Timepoint [7]
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up to 36 months
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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
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Minimum age
15
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
- 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
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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 assessing the outcomes
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
19/03/2015
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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
6/10/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
906
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0079 - Gateshead
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Local Institution - 0080 - Westmead
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Local Institution - 0078 - Wollstonecraft
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Local Institution - 0075 - Heidelberg
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Local Institution - 0085 - Nedlands
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Local Institution - 0081 - Camperdown
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2290 - Gateshead
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2145 - Westmead
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2065 - Wollstonecraft
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4120 - Greenslopes
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4215 - Southport
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5000 - Adelaide
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3084 - Heidelberg
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3181 - Prahran
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6009 - Nedlands
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2050 - Camperdown
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Recruitment outside Australia
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Surrey
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Ono Pharmaceutical Co. Ltd
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether nivolumab is better than ipilimumab to
prevent recurrence of melanoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02388906
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02388906
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