None listed
Conditions
Interventions
Nivolumab (BMS-936558) or placebo monotherapy administered IV over 30 minutes at 240 mg every 2 weeks for 16 weeks (8 doses) followed by nivolumab 480 mg as a 30 minute infusion every 4 weeks beginnin
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) All subjects must have Stage II or Stage III (per AJCC 7th edition) carcinoma of the esophagus or gastroesophageal junction and have histologically confirmed predominant adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer at the time of initial diagnosis. 2) Subjects must complete pre-operative chemoradiotherapy followed by surgery prior to randomization. Platinum based chemotherapy should be used. 3) Subject must have complete resection (R0), have been surgically rendered free of disease with negative margins on resected specimens. 4) Subject must have residual pathologic disease, ie, non-pathologic complete response (non-pCR) of their EC or GEJ, with at least ypN1 or ypT1 listed in the pathology report of the resected specimens. 5) ECOG performance status score of 0 or 1. 6) All subjects must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization.
Exclusion criteria
Exclusion criteria: 1) Subjects with cervical esophageal carcinoma. 2) Subjects with Stage IV resectable disease. 3) Treatment directed against the resected GEJ and esophageal cancer (eg, chemotherapy, targeted agents, radiation, or biologic therapy) that is administered after the complete resection. 4) Subjects with active, known, or suspected autoimmune disease. 5) Subjects with a condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. 6) Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity. 7) Known history or current of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 8) Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
Countries
Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Romania, Russian Federation, Spain, Switzerland, Turkey, United Kindgdom, United States
Contacts
Public ContactEddy Dumler
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed