A RANDOMIZED, MULTICENTER, DOUBLE BLIND, PHASE III STUDY OF ADJUVANT NIVOLUMAB OR PLACEBO IN SUBJECTS WITH RESECTED LOWER ESOPHAGEAL, OR GASTROESOPHAGEAL JUNCTION CANCER.

BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 0 人开始时间: 2016年7月20日最近更新: 2023年9月4日

研究概览

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•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.

•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.

发起方

BRISTOL MYERS SQUIBB PERU S.A.,