Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer (CheckMate649)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Junction Cancer; Gastric Cancer; Esophageal Adenocarcinoma

Treatments: Drug: Fluorouracil; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Ipilimumab; Drug: Leucovorin; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02872116

2016-001018-76 (EudraCT Number)

CA209-649

Details and patient eligibility

About

The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

Enrollment: 2,031 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female at least 18 years of age
• Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
• Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
• Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
• Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion criteria

• Presence of tumor cells in the brain or spinal cord that have not been treated
• Active known or suspected autoimmune disease
• Any serious or uncontrolled medical disorder or active infection
• Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Any positive test result for hepatitis B or C indicating acute or chronic infection

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,031 participants in 5 patient groups

Nivolumab + Ipilimumab

Experimental group

Description:

Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy Enrollment is closed for this arm

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

XELOX (Oxaliplatin + Capecitabine)

Active Comparator group

Treatment:

Drug: Capecitabine

Drug: Oxaliplatin

FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)

Active Comparator group

Treatment:

Drug: Leucovorin

Drug: Oxaliplatin

Drug: Fluorouracil

Nivolumab + XELOX

Experimental group

Treatment:

Drug: Nivolumab

Drug: Capecitabine

Drug: Oxaliplatin

Nivolumab + FOLFOX

Experimental group

Treatment:

Drug: Nivolumab

Drug: Leucovorin

Drug: Oxaliplatin

Drug: Fluorouracil