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by Estudio Clínico Chile
Etapa actual del estudio en Chile: Reclutamiento (buscando participantes para el estudio clínico)
DESCRIPCIÓN
Este estudio pretende evaluar la eficacia y seguridad de PEMBROLIZUMAB más BELZUTIFAN más LENVATINIB o PEMBROLIZUMAB/QUAVONLIMAB más LENVATINIB versus PEMBROLIZUMAB más LENVATINIB como primera línea en participantes con cáncer renal de células claras avanzado.
Tumor Primario: Riñón
Fase: 3
Ramas de tratamiento:
- A: PEMBROLIZUMAB + BELZUTIFAN + LENVATINIB
- B: PEMBROLIZUMAB + QUAVONLIMAB + LENVATINIB
- C: PEMBROLIZUMAB + LENVATINIB
Criterios de inclusión: 1L para EIV
- Has histologically confirmed diagnosis of RCC with clear cell component
- Has received no prior systemic therapy for advanced ccRCC
- Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib
- Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
- Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation
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