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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/NCT02743494
Registration number
NCT02743494
Ethics application status
Date submitted
15/04/2016
Date registered
19/04/2016
Date last updated
18/09/2023
Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
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Scientific title
A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
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Secondary ID [1]
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2015-005556-10
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Secondary ID [2]
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CA209-577
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 577
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Other interventions - Placebo
Experimental: Nivolumab -
Placebo Comparator: Placebo -
Treatment: Drugs: 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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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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Disease-free Survival (DFS)
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Assessment method [1]
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Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first.
Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment
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Timepoint [1]
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From randomization to the date of recurrence or death (up to approximately 46 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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Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.
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Timepoint [1]
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From randomization to the date of death (up to approximately 46 months)
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Secondary outcome [2]
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Overall Survival Rate
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Assessment method [2]
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Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization
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Timepoint [2]
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From randomization to 1, 2 and 3 years later
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Eligibility
Key inclusion criteria
- Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
- Completed pre-operative chemo radiotherapy followed by surgery
- Diagnosed with residual pathologic disease after being surgically rendered free of
disease with negative margins following complete resection
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Minimum age
18
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
- Diagnosed with cervical esophageal carcinoma
- Diagnosed with Stage IV resectable disease
- Did not receive concurrent chemoradiotherapy prior to surgery
- Participants who have received a live/attenuated vaccine within 30 days of the first
treatment
Other protocol defined Inclusion/exclusion criteria could 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 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
14/07/2016
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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
11/10/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
794
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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 - 0200 - Blacktown
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Local Institution - 0098 - Gosford
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Local Institution - 0072 - Clayton
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Local Institution - 0156 - Perth
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Local Institution - 0099 - Hobart
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2148 - Blacktown
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2250 - Gosford
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2065 - St Leonards
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2340 - Tamworth
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4102 - Brisbane
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5000 - Adelaide
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Recruitment postcode(s) [7]
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3168 - Clayton
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Recruitment postcode(s) [8]
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6150 - Perth
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Recruitment postcode(s) [9]
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7000 - Hobart
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Recruitment outside Australia
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Taiwan
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State/province [137]
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Taipei
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Country [138]
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Turkey
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State/province [138]
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Adana
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Country [139]
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0
Turkey
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State/province [139]
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0
Erzurum
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Country [140]
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Turkey
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State/province [140]
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Istanbul
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Country [141]
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United Kingdom
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State/province [141]
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Greater London
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Country [142]
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United Kingdom
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State/province [142]
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Hampshire
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Country [143]
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United Kingdom
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State/province [143]
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0
Manchester
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Country [144]
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United Kingdom
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State/province [144]
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Surrey
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Country [145]
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United Kingdom
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State/province [145]
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0
Cardiff
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Country [146]
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United Kingdom
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State/province [146]
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London
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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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Country
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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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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of this study is to determine whether Nivolumab will improve disease-free
survival compared with placebo.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02743494
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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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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02743494
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