Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

Completed · Phase 3

Conditions studied: Squamous Cell Non-small Cell Lung Cancer

In brief

The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

Key facts

Study ID

NCT01642004

Run by

Bristol-Myers Squibb

People needed

272

Starts

2012-10-16

Expected to finish

2021-08-16

Last updated by the study team

2022-12-28

Who can join

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

You may qualify if…

• Men and women ≥18 years of age
• Subjects with histologically or cytologically-documented squamous cell NSCLC who present with Stage IIIB/IV disease or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiation therapy for locally advanced disease)
• Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease
• Measurable disease by computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

You may not qualify if…

• Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent)
• Subjects with carcinomatous meningitis
• Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
• Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
• Prior therapy with anti-Programmed death-1 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
• Prior treatment on the first line study CA184104 first line NSCLC study
• Prior treatment with Docetaxel
• Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
• Treatment with any investigational agent within 14 days of first administration of study treatment

Where it is running

• City Of Hope — Duarte, California, United States
• Local Institution - 0020 — Duarte, California, United States
• Local Institution - 0009 — New Haven, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Local Institution - 0004 — Tampa, Florida, United States
• Local Institution - 0153 — Marietta, Georgia, United States
• Local Institution - 0100 — Chicago, Illinois, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Local Institution - 0003 — Baltimore, Maryland, United States
• Local Institution - 0036 — Boston, Massachusetts, United States
• Local Institution - 0084 — Boston, Massachusetts, United States
• Local Institution - 0150 — Boston, Massachusetts, United States
• Local Institution - 0016 — Mineola, New York, United States
• Winthrop University Hospital — Mineola, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Local Institution - 0006 — New York, New York, United States
• Memorial Sloan Kettering Nassau — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Local Institution - 0008 — Durham, North Carolina, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• St Mary Medical Center — Langhorne, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Local Institution - 0011 — Philadelphia, Pennsylvania, United States
• Mayo Clinic in Arizona - Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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