Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Non-Small-Cell Lung Cancer

In brief

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.

Key facts

Study ID

NCT02659059

Run by

Bristol-Myers Squibb

People needed

324

Starts

2016-02-15

Expected to finish

2022-03-07

Last updated by the study team

2023-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and Women ≥ 18 years of age
• Diagnosed with stage IV Non-Small Cell Lung Cancer
• Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.

You may not qualify if…

• Subjects with untreated CNS metastases are excluded.
• Subjects with carcinomatous meningitis
• Subjects with an active, known or suspected autoimmune disease.
• Subjects with a condition requiring systemic treatment with either corticosteroids ( > 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.
• Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.
• Other protocol defined inclusion/exclusion criteria apply

Where it is running

• Sharp Memorial Hospital — San Diego, California, United States
• Cancer Center Of Central Connecticut — Plainville, Connecticut, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Winship Cancer Institute. — Atlanta, Georgia, United States
• Summit Cancer Care — Savannah, Georgia, United States
• Cancer Center Of Kansas — Wichita, Kansas, United States
• University Of Louisville Medical Center, Inc., Dba — Louisville, Kentucky, United States
• Johns Hopkins Cancer Center — Baltimore, Maryland, United States
• Local Institution - 0029 — Boston, Massachusetts, United States
• Local Institution - 0030 — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Local Institution - 0015 — Lincoln, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Local Institution - 0036 — Albuquerque, New Mexico, United States
• Lovelace Cancer Care — Albuquerque, New Mexico, United States
• New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
• New Mexico Cancer Care Center — Albuquerque, New Mexico, United States
• The Cancer Center at Presbyterian — Albuquerque, New Mexico, United States
• Local Institution - 0010 — Mineola, New York, United States
• Memorial Sloan Kettering Nassau — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Novant Health Oncology Specialists — Winston-Salem, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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