A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin (CheckMate 648)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Various Advanced Cancer

Treatments: Drug: Fluorouracil; Biological: Ipilimumab; Biological: Nivolumab; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03143153

2016-001514-20 (EudraCT Number)

CA209-648

Details and patient eligibility

About

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Enrollment: 970 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
• Male or Female at least 18 years of age
• Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
• 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 which are symptomatic or require treatment
• 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 and/or detectable virus

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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970 participants in 3 patient groups

Nivolumab + Ipilimumab

Experimental group

Treatment:

Biological: Nivolumab

Biological: Ipilimumab

Nivolumab + Cisplatin + Fluorouacil

Experimental group

Treatment:

Drug: Cisplatin

Biological: Nivolumab

Drug: Fluorouracil

Cisplatin + Fluorouracil

Active Comparator group

Treatment:

Drug: Cisplatin

Drug: Fluorouracil