An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy (CheckMate 451)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer

Treatments: Biological: Ipilimumab; Biological: Nivolumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02538666

CA209-451

2015-002441-61 (EudraCT Number)

Details and patient eligibility

About

In this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. The purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. Patients receiving treatment will be compared with patients taking placebo.

Enrollment: 907 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with histologically or cytologically confirmed extensive stage disease SCLC
• Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

• Subjects with symptomatic Central Nervous System (CNS) metastases
• Subjects receiving consolidative chest radiation
• Subjects with active, known, or suspected autoimmune disease are excluded
• All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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907 participants in 3 patient groups, including a placebo group

Nivolumab monotherapy

Experimental group

Description:

Nivolumab intravenous fusion

Treatment:

Biological: Nivolumab

Nivolumab and ipilimumab combination therapy

Experimental group

Description:

Nivolumab and ipilimumab intravenous fusion

Treatment:

Biological: Nivolumab

Biological: Ipilimumab

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo