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Trial record 1 of 1 for:    checkmate-577
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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
Last Update Posted : September 1, 2020
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 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 : May 23, 2016
Estimated Primary Completion Date : May 24, 2021
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 of adjuvant nivolumab in participants with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery [ Time Frame: Approximately 58 months after the first participant is randomized ]

Secondary Outcome Measures :
  1. Overall Survival of adjuvant nivolumab in participants with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery [ Time Frame: Approximately 77 months after the participant is randomized ]
  2. Overall survival rate [ Time Frame: Overall survival rate at 1, 2, and 3 years ]

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
More Information
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Additional Information:

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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
Last Update Posted: September 1, 2020
Last Verified: August 2020

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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