Phase 3 N=794 Randomized Double-blind Treatment

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

Advanced Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02743494 ↗

Enrolled (actual)

794

Serious AEs

37.3%

Results posted

Jun 2021

Primary outcome: Primary: Disease-free Survival (DFS) — 22.41; 11.04 Months — p=0.0003

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nivolumab (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Disease-free Survival (DFS)	22.41; 11.04	0.0003 sig
SECONDARY Overall Survival (OS)	51.71; 35.25	0.1064
SECONDARY Overall Survival Rates at 12-, 24-, and 36-months	87.5; 84.6; 68.1; 65.8; 56.9; 49.7	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02743494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.