Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment nivolumab
Phase phase 2
Target PD-1
Sponsor Bristol-Myers Squibb
Collaborator PPD
Start date April 2015
End date May 2021
Trial size 800 participants
Trial identifier NCT02409368, 2014-001285-10, CA209-171

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Nivolumab IV infusion
nivolumab

Primary Outcomes

Measure
Incidence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in subjects with advanced or metastatic SqNSCLC
time frame: Approximately 5 years

Secondary Outcomes

Measure
Incidence and to characterize the outcome of all high-grade (CTCAE v4.0 Grades 3-4), select adverse events
time frame: Approximately 5 years
Overall survival (OS) in all treated subject
time frame: Approximately 5 years
Investigator-assessed objective response rate (ORR)
time frame: Approximately 3 years
Median time to onset (Grades 3-4) of select adverse events
time frame: Approximately 5 years
Median time to resolution (Grades 3-4) of select adverse events
time frame: Approximately 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.