Childhood Solid Tumor Clinical Trial
Official title:
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
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. 3. "Trans-MetroPD1" ancillary sub-study is partially implemented since April 2022, and proposed to patients participating to second stage
1. First stage (closed): - Arm A: Nivolumab + Cyclophosphamide-Vinblastine - Arm B: Nivolumab + Capecitabin - Arm C: Nivolumab + Cyclophosphamide-Vinblastine + Capecitabin Arm A and Arm B have been allocated sequentially (A/B/A/B/A/B). Arm C has been opened, since arm A and Arm B were deemed safe. In each arm, the second patient was not recruited before the first patient has been observed for a 28-day duration. 2. Second stage (opened): Following the analysis of safety data from first stage, and according to IDMC's recommendations on December 2020, the metronomic chemotherapy selected for second stage was arm C: cyclophosphamide, capecitabine, vinblastine Randomization will be balanced 1:1, controlling for: - histological type: embryonal brain tumor, ependymoma, low-grade glioma, rhabdomyosarcoma, neuroblastoma, Ewing sarcoma, and other solid tumors after approval from coordinators, - and treating center, using a dynamic allocation of treatment (minimization program) with a random factor set at 0.8. 3. Trans-MetroPD1 is divided into 3 axes: - to evaluate the health-related quality of life - to measure the kinectis of progastrin/hPG80, a biomarker over-expressed in a wide range of cancers - to determine the distribution of immune cells within blood tissue ;
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