Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 907)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03090737

CA209-907

2016-003731-37 (EudraCT Number)

Details and patient eligibility

About

A study to evaluate the safety of Nivolumab in participants with advanced or metastatic non-small cell lung cancer

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non small cell lung cancer (Squamous or non-squamous)
• At least one prior anti-cancer therapy that did not work
• ECOG Performance Scale 0-1

Exclusion criteria

• Cancer that has spread to the brain or leptomeninges unless there is no evidence of progression by MRI for 8 weeks after treatment is complete and within 28 days before first dose of study drug
• Active, known or suspected autoimmune disease or infection
• Prior immuno-oncology therapy
• Corticosteroids within 2 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

Nivolumab

Experimental group

Description:

Specified Dose on Specified Days

Treatment:

Biological: Nivolumab