Expired Study
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Raleigh, North Carolina 27607


Purpose:

The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.


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.


NCT ID:

NCT02409368


Primary Contact:

Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb


Backup Contact:

N/A


Location Contact:

Raleigh, North Carolina 27607
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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