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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509360-24-00
Acronym
CA209-577
Enrollment
275
Registered
2024-03-13
Start date
2016-06-16
Completion date
2024-11-06
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with resected adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer

Brief summary

Disease-free survival is the primary endpoint of this study. Disease-free survival is the time between randomization date and first date of recurrence or death, whichever occurs first.

Detailed description

Overall survival and overall survival rates are secondary endpoints. -Overall Survival is time between the date of randomization and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive. -The overall survival rate at 1, 2, and 3 years is defined as the probability that a subject is alive at 1, 2, and 3 years, respectively, following randomization.

Interventions

DRUGPlacebo for BMS-936558
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Sponsors

Bristol Myers Squibb International Corporation
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Disease-free survival is the primary endpoint of this study. Disease-free survival is the time between randomization date and first date of recurrence or death, whichever occurs first.

Secondary

MeasureTime frame
Overall survival and overall survival rates are secondary endpoints. -Overall Survival is time between the date of randomization and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive. -The overall survival rate at 1, 2, and 3 years is defined as the probability that a subject is alive at 1, 2, and 3 years, respectively, following randomization.

Countries

Belgium, Czechia, Denmark, France, Germany, Ireland, Netherlands, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026