CompletedPhase 3NCT01642004

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

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.

Checked against the public recordLast updated Dec 28, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations127
SponsorBristol-Myers Squibb
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Bristol-Myers Squibb
Interventions being studied
Biological: Nivolumab; Drug: Docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic in Arizona - ScottsdaleScottsdale, Arizona
  • City Of HopeDuarte, California
  • Local Institution - 0020Duarte, California
  • Local Institution - 0009New Haven, Connecticut
  • Yale UniversityNew Haven, Connecticut
  • H. Lee Moffitt Cancer CenterTampa, Florida
  • Local Institution - 0004Tampa, Florida
  • Local Institution - 0153Marietta, Georgia
  • Local Institution - 0100Chicago, Illinois
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
  • Local Institution - 0003Baltimore, Maryland
  • Local Institution - 0036Boston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 28, 2022. Always confirm current availability with the study team.

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