Nivolumab in Combination With Metronomic Chemotherapy in Paediatrics Refractory / Relapsing Solid Tumors
Status:
Recruiting
Trial end date:
2028-01-01
Target enrollment:
Participant gender:
Summary
The study is a two-stage trial:
1. First stage (closed - 16 patients recruited in France):
Phase I feasibility trial to evaluate the safety of the combination of Nivolumab +
metronomic chemotherapy considering three possible metronomic chemotherapy regimens
2. Second stage (opened - 86 patients expected in France and Belgium):
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 (arm C:
cyclophosphamide, capecitabine, vinblastine), with or without nivolumab.