This trial is active, not recruiting.

Condition squamous cell non-small cell lung cancer
Treatment nivolumab (bms-936558)
Phase phase 2
Sponsor Bristol-Myers Squibb
Start date November 2012
End date January 2014
Trial size 100 participants
Trial identifier NCT01721759, 2012-003965-16, CA209-063


The purpose of the study is to assess the objective response rate (change in the tumor size from baseline) in subjects with advanced or metastatic squamous cell non-small cell lung cancer (NSCLC) treated with Nivolumab (BMS-936558) after failure of two prior systemic regimens

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Nivolumab (BMS-936558) will be dosed intravenously (IV) over 60 minutes at 3 mg/kg every two weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
nivolumab (bms-936558)

Primary Outcomes

Primary endpoint of Independent Radiology Review Committee (IRC)-assessed objective response rate (ORR)
time frame: 18 Months

Secondary Outcomes

The secondary endpoint of ORR as assessed by investigator
time frame: 18 Months

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: - Men and Women ≥18 years of age - Subjects with histologically- or cytologically-documented squamous cell NSCLC who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multi-modal therapy (radiation therapy, surgical resection or definitive chemoradiation for locally advanced disease - Eastern Cooperative Oncology Group (ECOG) PS 0 or 1 - Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least one additional systemic therapy - Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Exclusion Criteria: - Untreated central nervous system (CNS) metastases. Subjects are eligible if metastases are treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) - Subjects with carcinomatous meningitis - Active known or suspected autoimmune disease or subjects with interstitial lung disease - Prior treatment on either arm of study CA209-017 or CA184-104 - Prior therapy with anti-Programmed death-1 (anti-PD-1), anti-Programmed cell death ligand 1 (anti-PD-L1), anti-Programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways - Subjects with a condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug

Additional Information

Official title A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.