Investigation of Encorafenib and Cetuximab for BRAF-mutated Metastatic Colorectal Cancer

Encorafenib and Cetuximab in Patients With Metastatic, BRAFV600E-mutated, Colorectal Carcinoma: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland

This study is testing if the combination of encorafenib and cetuximab can help people with advanced colorectal cancer that has a specific genetic mutation feel better and live longer after other treatments.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pierre Fabre Pharma GmbH (Industry-sponsored)
• Drugs / interventions: cetuximab, binimetinib, Chemotherapy
• Locations: 70 sites (Braunau am Inn, Upper Austria and 69 other locations)
• Trial ID: NCT04673955 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the real-world effectiveness of the combination therapy of encorafenib and cetuximab in patients with metastatic colorectal carcinoma (mCRC) harboring the BRAFV600E mutation. It focuses on patients who have been pretreated with systemic therapy and have recently started or are about to start this targeted therapy. The study will document treatment outcomes and survival rates in a longitudinal manner, providing insights into the efficacy of this regimen in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with metastatic colorectal carcinoma and a confirmed BRAFV600E mutation who have been pretreated with systemic therapy.

Not a fit: Patients who have undergone more than two prior systemic regimens in the metastatic setting may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and overall survival for patients with BRAF-mutated metastatic colorectal cancer.

How similar studies have performed: The BEACON CRC trial, which utilized a similar approach, has shown significant success in improving treatment outcomes for patients with BRAFV600E-mutant mCRC.

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).

Where this trial is running

Braunau am Inn, Upper Austria and 69 other locations

• Clinic — Braunau am Inn, Upper Austria, Austria (Recruiting)
• Clinic — Linz, Upper Austria, Austria (Recruiting)
• Clinic — Feldkirch, Voralberg, Austria (Recruiting)
• Clinic — Vienna, Austria (Recruiting)
• Practice — Offenburg, Baden-Wurttemberg, Germany (Recruiting)
• Medical Care Centre — Ulm, Baden-Wurttemberg, Germany (Recruiting)
• Clinic — Ulm, Baden-Wurttemberg, Germany (Recruiting)
• Practice — Augsburg, Bavaria, Germany (Recruiting)
• Practice — Donauwörth, Bavaria, Germany (Recruiting)
• Clinic — Erlangen, Bavaria, Germany (Recruiting)
• Practice — München, Bavaria, Germany (Recruiting)
• Practice — Würzburg, Bavaria, Germany (Recruiting)
• Medical Car Centre — Aschaffenburg, Bayer, Germany (Recruiting)
• Medical Care Centre — Potsdam, Brandenburg, Germany (Recruiting)
• Practice — Celle, Lower Saxony, Germany (Recruiting)
• Medical Care Centre — Goslar, Lower Saxony, Germany (Recruiting)
• Practice — Göttingen, Lower Saxony, Germany (Recruiting)
• Medical Practice — Hanover, Lower Saxony, Germany (Recruiting)
• Practice — Hanover, Lower Saxony, Germany (Recruiting)
• Practice — Leer, Lower Saxony, Germany (Recruiting)
• Clinic — Weißenfels, Lower Saxony, Germany (Recruiting)
• Medical Practice — Wilhelmshaven, Lower Saxony, Germany (Recruiting)
• Practice — Rostock, Mecklenburg-Vorpommern, Germany (Recruiting)
• Practice — Rostock, Mecklenburg-Vorpommern, Germany (Recruiting)
• Clinic — Rostock, Melcklenburg-Vorpommern, Germany (Recruiting)
• Clinic — Aachen, North Rhine-Westphalia, Germany (Recruiting)
• Clinic — Bochum, North Rhine-Westphalia, Germany (Recruiting)
• Practice — Bonn, North Rhine-Westphalia, Germany (Recruiting)
• Clinic — Bonn, North Rhine-Westphalia, Germany (Recruiting)
• Practice — Bottrop, North Rhine-Westphalia, Germany (Recruiting)
• Clinic — Essen, North Rhine-Westphalia, Germany (Recruiting)
• Practice — Moers, North Rhine-Westphalia, Germany (Recruiting)
• Medical Care Centre — Mönchengladbach, North Rhine-Westphalia, Germany (Recruiting)
• Medical Care Centre — Mülheim, North Rhine-Westphalia, Germany (Recruiting)
• Medical Care Centre — Neuss, North Rhine-Westphalia, Germany (Recruiting)
• Clinic — Paderborn, North Rhine-Westphalia, Germany (Recruiting)
• Medical Care Centre — Porta Westfalica, North Rhine-Westphalia, Germany (Recruiting)
• Practice — Stolberg, North Rhine-Westphalia, Germany (Recruiting)
• Practice — Troisdorf, North Rhine-Westphalia, Germany (Recruiting)
• Clinic — Wuppertal, North Rhine-Westphalia, Germany (Recruiting)
• Practice — Bad Kreuznach, Rhineland-Palatinate, Germany (Recruiting)
• Practice — Kaiserslautern, Rhineland-Palatinate, Germany (Recruiting)
• Practice — Worms, Rhineland-Palatinate, Germany (Recruiting)
• Clinic — Saarbrücken, Saarland, Germany (Recruiting)
• Practice — Dresden, Saxony, Germany (Recruiting)
• Prctice — Naunhof, Saxony, Germany (Recruiting)
• Clinic — Torgau, Saxony, Germany (Recruiting)
• Practice — Halle, Saxony-Anhalt, Germany (Recruiting)
• Clinic — Köthen, Saxony-Anhalt, Germany (Recruiting)
• Practice — Köthen, Saxony-Anhalt, Germany (Recruiting)

Study contacts

• Study coordinator: Marion Schmoll

Conditions Metastatic Colorectal Carcinoma; BRAFV600E mutation