A Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C After Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma

CompletadoFase 1ClinicalTrials.gov

ID: NCT03980314Tipo: INTERVENTIONALInicio: 24 de jun de 2019Fin estimado: 6 de nov de 2023

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the drug levels, immunogenicity and safety of Nivolumab Process D to Nivolumab Process C after complete resection of stage IIIa/b/c/d or stage IV melanoma.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed stage IIIa/b/c/d or stage IV melanoma
Complete resection of Stage III disease that is documented on the surgical and pathology reports or complete resection of Stage IV disease with margins negative for disease that is documented on the pathology report
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Criterios de exclusión

Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured
Any significant acute or chronic medical illness that is uncontrolled
History of ocular/uveal melanoma
Active, known or suspected autoimmune disease
Systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.

Intervenciones

drug

Nivolumab

Specified dose on specified days

Ubicaciones

Local Institution - 0046

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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