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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 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 : June 9, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 15, 2016
First Posted Date  ICMJE April 19, 2016
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE May 23, 2016
Estimated Primary Completion Date May 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
  • 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 29 months after the first subject is randomized ]
  • 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 42 months after the first subject is randomized ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • 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 ]
  • Overall survival rate [ Time Frame: Overall survival rate at 1, 2, and 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Overall survival rate [ Time Frame: Overall survival rate at 1, 2, and 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
Official Title  ICMJE A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
Brief Summary The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Drug: Nivolumab
    Specified dose on specified days
  • Other: Placebo
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Nivolumab
    Intervention: Drug: Nivolumab
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2016)
760
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 11, 2025
Estimated Primary Completion Date May 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Czechia,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Peru,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02743494
Other Study ID Numbers  ICMJE CA209-577
2015-005556-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP