NCT05510895

Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AIO-KRK-0420 NeoBRAF is a single arm, multicenter, phase II trial with neoadjuvant encorafenib, binimetinib and cetuximab for patients with BRAF V600E mutated/pMMR localized colorectal cancer.

Detailed description

This is a single arm, multicenter, phase II trial for patients with unresected BRAF V600E mutated/pMMR localized colorectal cancer (CRC). Patients enrolled will be treated with neoadjuvant encorafenib (300mg QD), binimetinib (45mg BID) and cetuximab (500mg/m² biweekly) for 8 weeks. Neoadjuvant treatment will be followed by surgery. First Endpoint is TRG (Tumor-Regression-Grade) which will be analyzed centrally. Patients with TRG\>1 will receive adjuvant treatment with encorafenib (300mg QD), binimetinib (45mg BID) and cetuximab (500mg/m² biweekly) for up to 16 weeks. For patients with TRG\<2 EOT will be reached 4-6 weeks after last dosage of encorafenib, binimetinib and cetuximab and further treatment is at investigator discretion (CAPOX recommended). All subjects will be followed every 3 months after surgery for up to 4 years after start of recruitment.

Conditions

• Colorectal Cancer
• Colon Cancer
• BRAF V600E
• BRAF V600 Mutation
• Localized Cancer

Interventions

Type	Name	Description
DRUG	Binimetinib	Triplet combination administered neoadjuvant and adjuvant, depending on TRG

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-07-31
• Completion: 2025-01-31
• First posted: 2022-08-22
• Last updated: 2025-10-01

Locations

1 site across 1 country: Germany