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by Estudio Clínico Chile
Etapa actual del estudio en Chile: Reclutamiento (buscando participantes para el estudio clínico)
DESCRIPCIÓN
Este estudio evalúa la eficacia y seguridad de PEMBROLIZUMAB más LENVATINIB + QUIMIOTERAPIA comparado con PEMBROIZUMAB más QUIMIOTERAPIA como primera línea en pacientes con cáncer de esófago de células escamosas metastásico.
Tumor Primario: Esófago
Fase: 3
Ramas de tratamiento:
- A: PEMBROLIZUMAB + LENVATINIB + QUIMIOTERAPIA
- B: PEMBROIZUMAB + QUIMIOTERAPIA
Criterios de inclusión: CEIV escamoso sin terapia previa
- Inclusion Criteria:
- Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
- Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
- Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab, 30 days after the last dose of lenvatinib, or 180 days after the last dose of chemotherapy, whichever occurs last, and agrees not to donate eggs during this period
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization
- Has adequate organ function
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