An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Advanced Cancer

Treatments: Drug: Nivolumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02743494

2015-005556-10 (EudraCT Number)

CA209-577

Details and patient eligibility

About

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

Enrollment: 794 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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794 participants in 2 patient groups, including a placebo group

Nivolumab

Experimental group

Treatment:

Drug: Nivolumab

Placebo

Placebo Comparator group

Treatment:

Other: Placebo