Lung Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

117

Study ID:

NCT01721759

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 33 Locations for this study

See Locations Near You

University Of California Davis Medical Center
Sacramento California, 95817, United States
Va San Diego Healthcare System
San Diego California, 92161, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
Winship Cancer Institute.
Atlanta Georgia, 30322, United States
Local Institution
Metairie Louisiana, 70006, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Providence Cancer Institute
Southfield Michigan, 48075, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Beth Israel Comprehensive Cancer Center
New York New York, 10011, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
University Of North Carolina At Chapel Hill
Chapel Hill North Carolina, 27599, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
The Ohio State University
Columbus Ohio, 43210, United States
Providence Oncology And Hematology
Portland Oregon, 97213, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Network Office of Research and Innovation
Allentown Pennsylvania, 18103, United States
University Of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Henry-Joyce Cancer Center
Nashville Tennessee, 37232, United States
Oncology Consultants, Pa
Houston Texas, 77024, United States
Local Institution
Caen , 14000, France
Local Institution
Creteil , 94010, France
Local Institution
Pierre Benite , 69495, France
Local Institution
Rennes , 35033, France
Local Institution
Strasbourg , 67090, France
Local Institution
Toulouse , 31059, France
Local Institution
Villejuif , 94800, France
Local Institution
Berlin , 13125, Germany
Local Institution
Koeln , 50937, Germany
Local Institution
Muenchen , 80336, Germany
Local Institution
Livorno , 57100, Italy
Local Institution
Lucca , 55100, Italy
Local Institution
Terni , 05100, Italy

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

117

Study ID:

NCT01721759

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

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