NCT06578559

Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC

Single Arm Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients With BRAF V600E Mutated mCRC (BRICKET)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a proof-of-concept, multicenter, open-label, single arm one-stage phase II trial of a ctDNA-guided retreatment with encorafenib plus cetuximab for mCRC patients bearing the BRAFV600E mutation and with the key following characteristics: * initial benefit and then secondary resistance to a previous exposure to encorafenib and cetuximab with or without chemotherapy; * only one subsequent intervening anti-BRAF and anti-EGFR-free line of therapy; * confirmed BRAFV600E mutated status and no detectable mutations in KRAS, NRAS, MAP2K1 and no amplification of MET in ctDNA at the time of retreatment; Eligible patients will receive Encorafenib 300 mg once daily (four 75 mg oral capsules) and Cetuximab 500 mg/sqm iv infusion every 14 days.Treatment will be delivered in 28-day cycles until disease progression, unacceptable toxic effects, withdrawal of consent, initiation of subsequent anticancer therapy, or death.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab	500 mg/sqm intravenous infusion over 120-minute at cycle 1 (if well tolerated, it is administered over 90 minutes at second administration, and over 60 minutes by the third administration) every 14 days.
DRUG	Encorafenib	300 mg once daily (four 75 mg oral capsules).

Timeline

• Start date: 2024-07-23
• Primary completion: 2026-08-01
• Completion: 2027-04-01
• First posted: 2024-08-29
• Last updated: 2026-01-05

Locations

13 sites across 1 country: Italy