This is an open-label, unicentre, single-arm Phase 2 study of encorafenib and cetuximab as rechallenge treatment in patients with BRAF V600E-mutant metastatic colorectal cancer after previous therapy with BRAF inhibitors-based combinations.
The study aims to evaluate the antitumor activity of encorafenib plus cetuximab as a rechallenge strategy measured by progression-free survival rate at 4 months.
Eligible patients (a total of 25) will receive encorafenib 300 mg (four 75 mg capsules) once daily (q.d) in 28-day cycles plus intravenous cetuximab at 500 mg/m2 every 2 weeks (Q2W). Treatment will be administered until progression, unacceptable toxicity, patient request, physician's decision or subsequent anticancer therapy.
Provision of signed and dated informed consent form.
Age ≥18 years at the time of informed consent.
Histologically- or cytologically confirmed mCRC that is metastatic.
Presence of confirmed BRAF V600E mutation.
Treatment with another investigational drug or participation in another investigational study at enrolment or within 30 days prior to enrollment.
Patient unable to comply with the study protocol owing to psychological, social (lack of social support or social exclusion) or geographical reasons.
Patient is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
Known history of chronic pancreatitis.
Single group
Rechalange with bevacizumab + encorafenib
DrugPatients will receive encorafenib 300mg once daily plus cetuximab 500mg/m2 every 2 weeks until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy or death.
Progression free survival
Progression-free survival rate at 4 months (4-month PFS rate) according to RECIST V1.1 by Investigator assessment.
Progression-free survival
Progression-free survival (PFS) according to RECIST V1.1 by Investigator assessment.
Objective response rate
Description: Objective Response Rate (ORR) according to RECIST V1.1 by Investigator assessment.
Overal Survival
Overall survival (OS)
Evaluate the safety and tolerability profile
Incidence and severity of adverse events (AEs), graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Change in clinical laboratory test parameters, vital signs, ECGs and echocardiogram/MUGA scans.
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