Last updated on November 2017

A Randomized, Multicenter, Double Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo as Maintenance Therapy in Subjects with Extensive-Stage Disease Small Cell Lung Cancer (SCLC) after Completion of Platinum-based First Line Chemotherapy


Brief description of study

A Randomized, Multicenter, Double Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo as Maintenance Therapy in Subjects with Extensive-Stage Disease Small Cell Lung Cancer (SCLC) after Completion of Platinum-based First Line Chemotherapy

Detailed Study Description

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) in subjects with Small Cell Lung Cancer (SCLC).

BMS would like to find out from this study if nivolumab or nivolumab with ipilimumab helps improve the survival of patients with SCLC, and if it can delay the progression of lung cancer when compared to placebo.

Nivolumab (Opdivo ™) has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer) and a different type of previously treated advanced lung cancer. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells.

Clinical Study Identifier: TX8016

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Pamela Treas

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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