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

NCT02743494

Description:

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

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT02743494

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal or Gastroesophageal Junction Cancer
  • Official Title: A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

Clinical Trial IDs

  • ORG STUDY ID: CA209-577
  • SECONDARY ID: 2015-005556-10
  • NCT ID: NCT02743494

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
NivolumabNivolumab

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
NivolumabExperimentalSpecified dose on specified days.
  • Nivolumab
PlaceboPlacebo ComparatorSpecified dose on specified days.

    Eligibility 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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure: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
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Overall survival rate
    Time Frame:Overall survival rate at 1, 2, and 3 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Last Updated

    September 1, 2017