BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment

Launched by PIERRE FABRE PHARMA GMBH · Dec 13, 2020

Keywords

ClinConnect Summary

The BERING CRC trial is investigating the effectiveness and safety of two medications, encorafenib and cetuximab, for patients with a specific type of metastatic colorectal cancer (mCRC) that has a BRAFV600E mutation. This mutation is known to make the cancer harder to treat, leading to shorter survival times with standard therapies. The goal of this study is to see how well these two drugs work together in real-life settings, focusing on patients who have already received treatment.

To be eligible for this study, participants must be at least 18 years old, have the BRAFV600E mutation in their metastatic colorectal cancer, and have undergone previous treatments. They should also be starting the combination therapy of encorafenib and cetuximab within three months of joining the study. Participants will contribute to understanding how this treatment works outside of clinical trials, which could help improve care for future patients. It's important to note that those who have had more than two prior treatments for their cancer or are currently involved in other clinical trials cannot participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent of the patient with regard to the pseudonymized documentation of his/her data in the frame of this non-interventional study
• • Legally capable patient ≥ 18 years of age (no upper limit)
• • Metastatic colorectal carcinoma with BRAFV600E-mutation, pretreated with systemic therapy
• • Decision was taken to treat the patient with the doublet therapy (encorafenib and cetuximab) in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
• • Treatment with the doublet therapy (encorafenib plus cetuximab) has been started ≤ 3 months prior to providing written informed consent for this study or is planned to be started in the near future.
• Exclusion Criteria:
• • More than 2 prior systemic regimens in the metastatic setting (adjuvant systemic therapy with relapse ≤ 6 months will be counted as metastatic treatment line; maintenance treatment will not be counted as separate metastatic treatment line)
• • Prior treatment with any RAF-inhibitor or MEK-inhibitor.
• • Presence of any contraindication with regard to the doublet therapy (encorafenib plus cetuximab) as specified in the corresponding SmPCs
• • Current or upcoming participation in an interventional clinical trial
• • Current or upcoming systemic treatment of any other tumor than metastatic colorectal carcinoma
• • Prisoners or persons who are compulsorily detained (involuntarily incarcerated).