Pierre Fabre W00090 GE 2 01 ANCHOR
Research type
Research Study
Full title
Phase II, open-label, single arm, multicenter study of encorafenib, binimetinib plus cetuximab in subjects with previously untreated BRAF V600E -mutant Metastatic Colorectal Cancer
IRAS ID
257061
Contact name
Paul Jonathan Ross
Contact email
Sponsor organisation
Pierre Fabre Laboratories
Eudract number
2018-000271-32
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 9 months, 17 days
Research summary
Research Summary
Metastatic colorectal cancer (mCRC) continues to be a serious, life-threatening condition. It's estimated that there are 1.36 million new cases diagnosed each year leading to 693,000 deaths worldwide from colorectal cancer (CRC). Approximately 10% of CRC cases test positive for BRAF (B-RAF proto-oncogene, serine/threonine kinase) mutation, which is considered a marker of poor prognosis in subjects with mCRC, especially the BRAF v600E mutation. The purpose of this study is to evaluate if the combination of study drugs encorafenib + binimetinib and cetuximab are safe and have beneficial effects in people who have BRAF V600E-mutant metastatic colorectal cancer and have not received any treatment yet for their metastatic disease. Each one of the study drugs blocks different proteins (called MEK, BRAF and EGFR, respectively) and could potentially have an effect in patients whose tumour has the BRAF-mutation.
Study treatment (encorafenib, binimetinib and cetuximab) will be administered until unacceptable toxicity, progression of disease, particpant’s decision, withdrawal of consent, initiation of subsequent anticancer therapy or death.
The study comprises of a screening part (up to 28 days), a Treatment period (according to a 28-day cycle) and Follow-up visits (at end of treatment and approximately 30 days after the last dose of study treatment).
It is expected that about 90 patients will participate in approximately 40 sites around Europe and North America. In the UK it is expected that the study will take place in 06 sites.Summary of Results
The results of this clinical trial show that the combination of encorafenib, binimetinib, and cetuximab is effective and safe for treating, as a first therapy, patients with a type of colorectal cancer called BRAF-mutant mCRC, which is cancer that has a particular genetic mutation. In terms of effectiveness, the study found that the treatment met its main goal, with approximately 48% of patients showing a positive response. A positive response is a significant reduction at a time of the size of the tumours as measured on scans regularly performed throughout the study. The median time until the disease progressed (median progression-free survival) was approximately 5.8 months when assessed by the physician and 5.0 months when assessed by radiologists reviewing the patients’ scans independently. The median overall survival time, which represents the midpoint where half of the patients in the study treatment group are still alive was about 17.2 months. In terms of safety, the side effects observed were similar to what we already know about these type of combination therapies in colorectal cancer; there were no new safety concerns identified. The side effects were consistent throughout the study, and there were no deaths related to the treatments. Overall, the results of this study suggest that the combination of encorafenib, binimetinib, and cetuximab is a viable option for treating BRAF-mutantmCRC, with similar effectiveness and safety compared to other recommended treatments for this typeof cancer.
REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/0084
Date of REC Opinion
14 Mar 2019
REC opinion
Further Information Favourable Opinion