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)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01673867Tipo: INTERVENTIONALInicio: 2 de nov de 2012Fin estimado: 17 de dic de 2021

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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 hormone replacement, or 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

Intervenciones

biological

Nivolumab

drug

Docetaxel

Ubicaciones

Local Institution - 0010

Capital Federal, Buenos Aires, Argentina

Local Institution - 0057

Capital Federal, Buenos Aires, Argentina

Local Institution - 0124

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0011

Buenos Aires, Argentina

Local Institution - 0125

La Rioja, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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