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-RO

Enrollment

1085

Registered

2016-06-28

Start date

2016-11-15

Completion date

Unknown

Last updated

2024-10-21

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: 19.0 Level: LLT Classification code 10015362 Term: Esophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10062878 Term: Gastrooesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA ver

Interventions

Product Name: Nivolumab Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Nivolumab CAS Number: 946414-94-4 Other descriptive name: BMS936558 Concentra

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 835 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

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

Secondary

Measure	Time frame
Secondary end point(s): 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: Overall survival rate at 1, 2, and 3 years	—

Primary

Measure	Time frame
Main Objective: The purpose of this study is to determine whether nivolumab will improve overall survival, disease-free survival, or both compared with placebo in subjects with resected Esophageal or Gastroesophageal Junction Cancer. ;Secondary Objective: To evaluate 1, 2, and 3 year survival rates of nivolumab versus placebo in subjects with resected Esophageal or Gastroesophageal Junction Cancer;Primary end point(s): Overall survival and Disease-Free Survival are co-primary endpoints. - Disease-Free Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery - Overall Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery;Timepoint(s) of evaluation of this end point: - DFS: Approximately 29 months after the first subject is randomized - OS: Approximately 42 months after the first subject is randomized	—

Measure

Time frame

Main Objective: The purpose of this study is to determine whether nivolumab will improve overall survival, disease-free survival, or both compared with placebo in subjects with resected Esophageal or Gastroesophageal Junction Cancer. ;Secondary Objective: To evaluate 1, 2, and 3 year survival rates of nivolumab versus placebo in subjects with resected Esophageal or Gastroesophageal Junction Cancer;Primary end point(s): Overall survival and Disease-Free Survival are co-primary endpoints. - Disease-Free Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery - Overall Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery;Timepoint(s) of evaluation of this end point: - DFS: Approximately 29 months after the first subject is randomized - OS: Approximately 42 months after the first subject is randomized

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Countries

Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Spain, Switzerland, Turkey, 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