Phase II clinical trial - Pédiatrie Tumeurs solides

Pédiatrie Tumeurs solides
Ouvert depuis le: 12.01.2023
Site: Paris
Public cible
Metro-PD1: a phase I/II trial evaluating anti-PD1 (Nivolumab) in combination with metronomic chemotherapy in children and teenagers with refractory /relapsing solid tumors or lymphoma
Description de l'essai
The study is a two-stage trial:;1.First stage : Phase I feasibility trial to evaluate the safety of the combination of Nivolumab + metronomic chemotherapy considering three possible metronomic chemotherapy regimens;2.Second stage: Phase II randomized controlled balanced 1:1 open- label trial comparing the efficacy of the metronomic chemotherapy regimen selected at the end of the previous stage, with or without nivolumab.