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

Sponsor
Bristol-Myers Squibb
Study ID
NCT02409368
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 29, 2015
Status verified
Oct 2022
Primary completion
Mar 7, 2018
Completion
Aug 27, 2021

Study Design

Enrollment
812 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Cohort A: Treatment - Nivolumab
    Nivolumab IV infusion

Primary Outcome Measure

Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events [ Time Frame: From first dose to time of analysis of primary endpoint (approximately up to 34 months) ]

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