An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

CompletadoFase 3ClinicalTrials.gov

ID: NCT02105636Tipo: INTERVENTIONALInicio: 29 de may de 2014Fin estimado: 10 de sept de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting

Criterios de exclusión

Active brain metastases or leptomeningeal metastases are not allowed
Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowed
Subjects with active, known or suspected autoimmune disease

Intervenciones

drug

Nivolumab

drug

Cetuximab

drug

Methotrexate

drug

Docetaxel

Ubicaciones

Local Institution - 0015

Berazategui, Buenos Aires, Argentina

Local Institution - 0013

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0014

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorOno Pharmaceutical Co. Ltd

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