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An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02743494
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Results First Posted : June 22, 2021
Last Update Posted : March 1, 2023
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Nivolumab Other: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 794 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
Actual Study Start Date : July 14, 2016
Actual Primary Completion Date : May 12, 2020
Estimated Study Completion Date : October 11, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab Drug: Nivolumab
Specified dose on specified days
Placebo Comparator: Placebo Other: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free Survival (DFS) [ Time Frame: From randomization to the date of recurrence or death (up to approximately 46 months) ]

    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



Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization to the date of death (up to approximately 46 months) ]
    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.

  2. Overall Survival Rate [ Time Frame: From randomization to 1, 2 and 3 years later ]
    Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743494


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] June 6, 2019
Statistical Analysis Plan  [PDF] September 30, 2020

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02743494    
Other Study ID Numbers: CA209-577
2015-005556-10 ( EudraCT Number )
First Posted: April 19, 2016    Key Record Dates
Results First Posted: June 22, 2021
Last Update Posted: March 1, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action