drugset / Trial / NCT04776655
Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB
Phase 3
Recruiting
280 enrolled
Azienda USL Reggio Emilia - IRCCS
Istituto Di Ricerche Farmacologiche Mario Negri · collabIstituto Nazionale Tumori IRCCS - Fondazione G. Pascale · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a prospective, randomized phase III, to evaluate if in patients with mCRC RAS/BRAF wild type on tumor tissue and RAS mutations on liquid biopsy, treating in first line with antibody anti-VEGF (bevacizumab) plus chemotherapy (FOLFIRI) is superior in terms of PFS compared to standard treatment with antibody anti-EGFR (cetuximab) plus FOLFIRI, and then in patients RAS/BRAF wild type on tumor tissue who develop RAS mutations on liquid biopsy after the beginning of the first line treatment with cetuximab plus FOLFIRI, in the absence of a clinical or radiological progression disease, to anticipate a change of treatment with bevacizumab plus FOLFIRI further impacts on the PFS.
Timeline
- Start
- 2021-04-30
- Primary completion
- 2025-05-04
- Completion
- 2026-05-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Comparator | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | — | — |
| Background | Levoleucovorin | Unknown | — | — |
| Background | fluorouracil | Small molecule | — | — |