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 o

• Status: Completed
• Trial end date: 2021-08-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: PPD
• Treatments: Antibodies, Monoclonal; Nivolumab

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.