CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen
Status:
Recruiting
Trial end date:
2026-06-15
Target enrollment:
Participant gender:
Summary
This clinical program aims to evaluate the activity and efficacy of cetuximab continuation of
treatment for three lines of therapy with rotation of chemotherapy (FOLFIRI, FOLFOX,
irinotecan) in mCRC patients, whose tumors remain RAS/BRAF WT. The study will also evaluate
the activity and efficacy of cetuximab re-introduction in combination with irinotecan as
third line therapy in the concept of re-challenge for those patients that will be treated in
second line with chemotherapy plus anti-angiogenic drugs (FOLFOX plus bevacizumab), having a
RAS or BRAF mutant disease at the time of progression after FOLFIRI plus cetuximab first line
treatment. A novel characteristic of this program is that the therapeutic algorithm will be
defined at each treatment decision (first line, second line and third line) in a prospective
fashion in each patient by liquid biopsy assessment of RAS/BRAF status.