An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects Wit… (NCT02409368) | Clinical Trial Compass
CompletedPhase 2
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
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Timeframe: From first dose to time of analysis of primary endpoint (approximately up to 34 months)