Overview

This trial is active, not recruiting.

Condition non-squamous cell non-small cell lung cancer
Treatments nivolumab, docetaxel
Phase phase 3
Target PD-1
Sponsor Bristol-Myers Squibb
Start date October 2012
End date February 2015
Trial size 574 participants
Trial identifier NCT01673867, 2012-002472-14, CA209-057

Summary

The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
nivolumab BMS-936558 (Anti-PD1)
(Active Comparator)
Docetaxel 75 mg/m² concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
docetaxel Taxotere®

Primary Outcomes

Measure
Overall Survival
time frame: Month 6
Overall Survival
time frame: Month 12
Overall Survival
time frame: Month 18
Overall Survival
time frame: Month 24
Overall Survival
time frame: Month 36
Overall Survival
time frame: Month 48
Overall Survival
time frame: Year 5

Secondary Outcomes

Measure
Objective response rate (ORR) of BMS-936558 (Nivolumab) versus Docetaxel
time frame: 6, 12, 18, 24, 36, 48 months and 5 year
Progression-free survival (PFS) of BMS-936558 (Nivolumab) versus Docetaxel
time frame: 6, 12, 18, 24, 36, 48 months and 5 year
PD-L1 protein expression
time frame: 6, 12, 18, 24, 36, 48 months and 5 year
Disease-related symptom improvement rate
time frame: Up to Week 12

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 & women ≥18 years of age - Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for advanced disease - Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease - Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria - Eastern Cooperative Oncology Group (ECOG) performance status ≤1 - A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient Exclusion Criteria: - Subjects with untreated central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent) - Subjects with carcinomatous meningitis - Subjects with active,or recent history of known or suspected autoimmune disease. Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll - Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization - 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-cluster of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) - Prior treatment with Docetaxel - Treatment with any investigational agent within 14 days of first administration of study treatment

Additional Information

Official title An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Description CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.