drugset / Trial / NCT06578559
Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC
Phase 2
Active not recruiting
16 enrolled
Gruppo Oncologico del Nord-Ovest
Merck Sharp & Dohme LLC · collabPierre Fabre Laboratories · collab
NaSingle-groupOpen-labelTreatment
Summary
The aim of this study is to evaluate the activity, in terms of best response according to RECIST criteria 1.1 as assessed by the local investigator, of the ctDNA-guided retreatment with encorafenib plus cetuximab in BRAFV600E mutated mCRC patients experiencing benefit from previous exposure to encorafenib plus cetuximab (+/- chemotherapy) and with BRAFV600E mutated, KRAS, NRAS and MAP2K1 wild-type and MET not amplified status on ctDNA at the time of study entry.
Timeline
- Start
- 2024-07-23
- Primary completion
- 2026-08-01
- Completion
- 2027-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Encorafenib | Small molecule | 300 mg | Oral |