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Trial record 1 of 1 for:    CA209-577
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An Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)

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ClinicalTrials.gov Identifier: NCT02743494
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo.

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

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 : September 14, 2020
Estimated Study Completion Date : October 11, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab
Specified dose on specified days.
Drug: Nivolumab
Specified dose on specified days

Placebo Comparator: Placebo
Specified dose on specified days.
Other: Placebo
Specified dose on specified days




Primary Outcome Measures :
  1. Disease-Free Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery [ Time Frame: Approximately 36 months after the first subject is randomized ]
  2. Overall Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery [ Time Frame: Approximately 49 months after the first subject is randomized ]

Secondary Outcome Measures :
  1. Overall survival rate [ Time Frame: Overall survival rate at 1, 2, and 3 years ]


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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

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


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 211 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02743494     History of Changes
Other Study ID Numbers: CA209-577
2015-005556-10 ( EudraCT Number )
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs