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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2023 |
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Main ID: |
NCT02743494 |
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Date of registration:
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15/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
CheckMate 577 |
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Scientific title:
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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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Date of first enrolment:
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July 14, 2016 |
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Target sample size:
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794 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02743494 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Canada
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China
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Czech Republic
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Czechia
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Denmark
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France
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Germany
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Hong Kong
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Hungary
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Ireland
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Israel
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Italy
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Japan
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Korea, Republic of
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Mexico
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Netherlands
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Peru
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Poland
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Puerto Rico
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Romania
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Russian Federation
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Singapore
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Spain
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Switzerland
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Advanced Cancer
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Intervention(s)
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Other: Placebo
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Drug: Nivolumab
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Primary Outcome(s)
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Disease-free Survival (DFS)
[Time Frame: From randomization to the date of recurrence or death (up to approximately 46 months)]
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Secondary Outcome(s)
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Overall Survival (OS)
[Time Frame: From randomization to the date of death (up to approximately 46 months)]
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Overall Survival Rate
[Time Frame: From randomization to 1, 2 and 3 years later]
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Secondary ID(s)
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CA209-577
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2015-005556-10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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