Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients

Autores Roberto Iacovelli -Más
Categoría Estudio primario
Revistahttps://clinicaltrials.gov/show/NCT05817903
Año 2023
Enlaces Registro de estudios
The present study aims to demonstrate if the addition of axitinib to nivolumab maintenance after nivolumab plus ipilimumab induction can improve the rate of response considering that the incidence of partial response was 32% and 51% in Checkmate214 and Keynote426 trials respectively. This study requires 106 patients to show an improvement from 30% to 50% of the incidence of partial responses with a power of 80%, and alpha-error 0.10 (one-side p). Assuming a drop out of 10%, the final estimated number to enroll should be 118 (59 in arm A and 59 in arm B).
Epistemonikos ID: d67905afb69715495e2948ee69467accef7af75f
First added on: Feb 19, 2024