drugset / Trial / NCT05217069
FOLFIRI + Cetuximab + Avelumab RAS Wild-type CRC
Phase 2
Completed
57 enrolled
Ludwig-Maximilians - University of Munich
ClinAssess · collabMerck KGaA, Darmstadt, Germany · collab
NaSingle-groupOpen-labelTreatment
Summary
Within the proposed single arm multicenter phase-II trial it is intended to investigate the feasi-bility of adding Avelumab to FOLFIRI plus Cetuximab after 4 cycles (2 months) of treatment with FOLFIRI plus Cetuximab. After 4 more cycles of FOLFIRI plus Cetuximab plus Avelumab the treatment will be de-escalated to Avelumab as a maintenance concept until progression of the disease according to RECIST 1.1 has occurred.
Timeline
- Start
- 2019-09-27
- Primary completion
- 2023-09-01
- Completion
- 2023-10-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | 180 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |