drugset / Trial / NCT06750094
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
Timeline
- Start
- 2024-12-12
- Primary completion
- 2027-12-15
- Completion
- 2029-04-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amivantamab | Monoclonal antibody | — | — |
| Comparator | Bevacizumab | Monoclonal antibody | — | — |
| Comparator | Cetuximab | Monoclonal antibody | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Levoleucovorin | Unknown | — | — |
| Background | fluorouracil | Small molecule | — | — |