This study is in progress, not accepting new patients

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

a study on Cancer, General Gastroesophageal Junction Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Andrew Ko (ucsf)
Headshot of Andrew Ko
Andrew Ko

Description

Summary

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

Official Title

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

Keywords

Advanced Cancer, Nivolumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Pacific Hematology Oncology Associates
    San Francisco California 94115 United States
  • Local Institution - 0068
    San Francisco California 94158 United States
  • Local Institution - 0026
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Andrew Ko (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 147 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT02743494
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 794 people participating
Last Updated