Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer
NCT05510895 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2025-10-01
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.
Conditions
- Colorectal Cancer
- Colon Cancer
- BRAF V600E
- BRAF V600 Mutation
- Localized Cancer
Interventions
- DRUG
-
Binimetinib
Triplet combination administered neoadjuvant and adjuvant, depending on TRG
Sponsors & Collaborators
-
Pierre Fabre Pharma GmbH
collaborator INDUSTRY -
Merck Serono GmbH, Germany
collaborator INDUSTRY -
Universitätsklinikum Hamburg-Eppendorf
collaborator OTHER -
AIO-Studien-gGmbH
lead OTHER
Principal Investigators
-
Alexander Stein, Prof. Dr. · Hämatologisch-Onkologische Praxis Eppendorf, 20249 Hamburg, Germany
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2024-07-31
- Completion
- 2025-01-31
Countries
- Germany
Study Locations
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