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Active, Not Recruiting

An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC - CA209-171

Updated: 17 June, 2020   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Cohort A: Treatment - Nivolumab
Drug: Nivolumab

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - ECOG Status: PS 0-1 & PS 2 - Subjects with histologically or cytologically-documented SqNSCLC - Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen - Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria - Subjects with treated or asymptomatic CNS metastases - Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration - Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab - Males and Females, ages 18 or older Exclusion Criteria: - Subjects with untreated, symptomatic CNS metastases - Subjects with carcinomatous meningitis - Subjects with active, known or suspected autoimmune disease. - Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.

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