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Protocol No. UW16042

Principal Investigator Lubner, Sam

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

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

Objective The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). Nivolumab is an antibody (a type of of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. Another purpose of this study is to test how well we can detect the expression of a biomarker known as PD-L1. This type of test is known as an in vitro diagnostic, or IVD. The IVD in this study is an investigational device that is not approved by a regulatory authority.

Treatment You will be randomized (assigned by chance) to receive either nivolumab or placebo (a treatment that looks like nivolumab but contains no active study drug). There is a 66.7% chance that you will receive nivolumab and a 33.3% chance that you will receive placebo. Neither you nor your study doctor will know which treatment you are receiving, except in an emergency. Study treatments (nivolumab or placebo) will be started within 3 days of your randomization and will be given for up to one year unless your cancer recurs, you experience an unacceptable toxicity, or you withdraw your consent to participate in this trial.

Description Nivolumab or placebo will be administered every two weeks for the first 16 weeks (8 doses) by intravenous (IV) infusion, meaning the drug is a solution given through a vein. The infusion usually takes about a half hour (30 minutes). After the first 16 weeks of treatment (beginning at Week 17), nivolumab or placebo will be administered every four weeks.

Key Eligibility
  • All subjects must have Stage II or Stage III 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
  • Subjects must complete pre-operative chemoradiotherapy followed by surgery prior to randomization. Platinum based chemotherapy should be used
  • Subject must have complete resection (R0), have been surgically rendered free of disease with negative margins on resected specimens defined as no vital tumor present within 1 mm of the proximal, distal, or circumferential resection margins
  • Subject must have residual pathologic disease
  • Complete resection must be performed in a window 4-16 weeks prior to randomization
  • Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration
  • All subjects must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging studies must include CT/MRI scan of chest and abdomen
  • Tumor tissue from the resected site of disease must be provided for biomarker analyses
  • Women must not be breastfeeding
  • At a minimum, subjects must agree to the use one highly effective method of contraception
  • Subjects with cervical esophageal carcinoma are excluded
  • Subjects who only receive chemotherapy or only radiation prior to surgery are not eligible
  • Subjects with Stage IV resectable disease are not eligible
  • Subjects who have had treatment directed against the resected GEJ and esophageal cancer (eg, chemotherapy, targeted agents, radiation, or biologic therapy) that is administered after the complete resection are not eligible
  • Subjects with active, known, or suspected autoimmune disease are not eligible
  • 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. Inhaled or topical steroids, and adrenal replacement steroids >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways are not eligible
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are not eligible

Applicable Disease Sites Esophagus

Status Open

Participating Institutions UW Hospital and Clinics