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

  • Interventional
  • Not Recruiting
  • NCT02743494
Eligibility Details Visit Clinicaltrials.gov

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02743494

IRB#IRB16-0552

Lead SponsorBristol-Myers Squibb

Lead PhysicianDaniel Catenacci

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting