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

• Status: Active, not recruiting
• Trial end date: 2025-10-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Nivolumab

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

• Participants who have received a live/attenuated vaccine within 30 days of the first treatment

Other protocol defined Inclusion/exclusion criteria could apply