A study of nivolumab or placebo in patients following removal of their esophageal or gastroesophageal junction cancer.

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer - CheckMate 577: CHECKpoint pathway and nivoluMab clinical Trial Evaluation 577

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005556-10-HU

Enrollment

1113

Registered

2016-04-13

Start date

2016-05-24

Completion date

Unknown

Last updated

2025-02-03

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 MedDRA version: 21.0 Level: LLT Classification code 10015362 Term: Esophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA ver

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-CLINICAL Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Nivolumab CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - subjects diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction - subjects completed pre-operative chemoradiotherapy followed by surgery - subjects diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 857 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 256

Exclusion criteria

Exclusion criteria: -subjects diagnosed with cervical esophageal carcinoma -subjects diagnosed with Stage IV resectable disease -subjects who did not receive concurrent chemoradiotherapy prior to surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: -To compare disease-free survival (DFS) of nivolumab versus placebo in subjects with resected esophageal cancer (EC), or gastro-esophageal junction (GEJ) cancer ;Secondary Objective: - To compare overall survival (OS) of nivolumab versus placebo in subjects with resected EC or GEJ cancer. - To evaluate 1, 2, and 3 year survival rates of nivolumab versus placebo in subjects with resected EC or GEJ cancer ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Subjects will be evaluated for disease recurrence every 12 weeks from the date of first treatment for the first 2 years, and then every 6-12 months between years 3-5.	—

Measure

Time frame

Main Objective: -To compare disease-free survival (DFS) of nivolumab versus placebo in subjects with resected esophageal cancer (EC), or gastro-esophageal junction (GEJ) cancer ;Secondary Objective: - To compare overall survival (OS) of nivolumab versus placebo in subjects with resected EC or GEJ cancer. - To evaluate 1, 2, and 3 year survival rates of nivolumab versus placebo in subjects with resected EC or GEJ cancer ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Subjects will be evaluated for disease recurrence every 12 weeks from the date of first treatment for the first 2 years, and then every 6-12 months between years 3-5.

—

Secondary

Measure	Time frame
Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: up to 5 years from the last patient last treatment	—

Measure

Time frame

Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: up to 5 years from the last patient last treatment

—

Countries

Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russian Federation, Singapore, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026