Nivolumab in Combination With Metronomic Chemotherapy in Paediatrics Refractory / Relapsing Solid Tumors
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. 3. "Trans-MetroPD1" ancillary sub-study is partially implemented since April 2022, and proposed to patients participating to second stage
Timeline
- Start
- 2019-03-26
- Primary completion
- 2025-05-31
- Completion
- 2025-12-27
Outcome
Outcome not reported
Stopped: “Analysis conducted on spring 2025, according to the provisional schedule: the results were sufficient to conclude about all endpoints, and the sponsor defined a new end of trial on 27 Dec 2025 (modification approved on CTIS on May 26, 2026).”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 400 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 600 mg/m2 | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 30 mg/m2 | Oral |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Vinblastine | Small molecule | 2 mg/m2 | Intravenous |