Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens

Completed · Phase 2

Conditions studied: Squamous Cell Non-small Cell Lung Cancer

In brief

The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens

Key facts

Study ID

NCT01721759

Run by

Bristol-Myers Squibb

People needed

117

Starts

2012-11-16

Expected to finish

2021-04-22

Last updated by the study team

2022-06-28

Who can join

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

You may qualify if…

• Men and women ≥18 years of age
• Patients with histologically or cytologically documented squamous cell nonsmall-cell lung cancer who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation for locally advanced disease
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
• Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1

You may not qualify if…

• Untreated central nervous system (CNS) metastases. Metastases have been treated and patients neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, patients must have stopped taking corticosteroids or be taking a stable or decreasing dose of ≤10 mg prednisone daily (or equivalent)
• Carcinomatous meningitis
• Active known or suspected autoimmune disease or interstitial lung disease
• Prior treatment on either arm of study CA209-017 or CA184-104
• Prior therapy with anti-Programmed death-1 (anti-PD-1), anti-Programmed cell death ligand 1 (anti-PD-L1), anti-Programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
• A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug

Where it is running

• University Of California Davis Medical Center — Sacramento, California, United States
• Va San Diego Healthcare System — San Diego, California, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Winship Cancer Institute. — Atlanta, Georgia, United States
• Local Institution — Metairie, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Providence Cancer Institute — Southfield, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Beth Israel Comprehensive Cancer Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University Of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Providence Oncology And Hematology — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Network Office of Research and Innovation — Allentown, Pennsylvania, United States
• University Of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Henry-Joyce Cancer Center — Nashville, Tennessee, United States
• Oncology Consultants, Pa — Houston, Texas, United States
• Local Institution — Caen, France
• Local Institution — Créteil, France
• Local Institution — Pierre-Bénite, France
• Local Institution — Rennes, France
• Local Institution — Strasbourg, France

Full record on ClinicalTrials.gov

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