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

Recruiting · NCT04673955 · Observational (researchers observe without assigning treatment) · Lead sponsor: Pierre Fabre Pharma GmbH

Interventions studied

What this trial is about

The presence of a BRAFV600E mutation is a marker of poor prognosis in patients with mCRC and associated with a median overall survival (mOS) of approximately 12 to 14 months compared to 20 to 25 months for patients with BRAF wild-type tumours. After 1st line therapy, treatment outcomes with standard therapy are poor in patients with BRAF-mutated mCRC, with response rates (ORR) of ≤ 11%, a median progression-free survival (mPFS) between 1.8 and 2.8 months, and a mOS between 4.1 and 6.2 months. Failure to achieve adequate survival outcomes with standard treatment regimens in patients with BRAF-mutated mCRC has encouraged efforts to combine multiple targeted therapies: With 665 randomized patients, the BEACON CRC trial represents the largest trial and is currently the only phase III study in patients with BRAFV600E-mutant mCRC. BERING CRC - designed as a prospective (allowing initial retrospective documentation), longitudinal, non-interventional study - will investigate the real-world effectiveness, quality of life, safety and tolerability of encorafenib and cetuximab in BRAFV600E-mutant mCRC patients, who have received prior systemic therapy. Data from this study will contribute to a deeper understanding and characterization to the everyday use of encorafenib and cetuximab in a broader patient population in the German, Austrian, and Swiss routine setting.

Who can take part

Where it is running

60 locations listed.

• Hospital - Aschaffenburg, Germany
• Medical Care Centre - Berlin, Germany
• Practice - Berlin, Germany
• Practice - Berlin, Germany
• Clinic - Berlin, Germany
• Private Practice - Berlin, Germany
• Private Practice - Dresden, Germany
• Hospital - Esslingen am Neckar, Germany
• Practice - Hamburg, Germany
• Practice - Hamburg, Germany
• Private Practice - Heidelberg, Germany
• Private Practice - Leer, Germany
• Private Practice - Lübeck, Germany
• Private Practice - Naunhof, Germany
• Private Practice - Offenburg, Germany
• Private Practice - Oldenburg in Holstein, Germany
• Private Practice - Schorndorf, Germany
• Clinic - Vienna, Austria
• Private Practice - Würzburg, Germany
• Practice - Offenburg, Baden-Wurttemberg, Germany
• Medical Care Centre - Ulm, Baden-Wurttemberg, Germany
• Clinic - Ulm, Baden-Wurttemberg, Germany
• Practice - Augsburg, Bavaria, Germany
• Practice - Donauwörth, Bavaria, Germany
• Clinic - Erlangen, Bavaria, Germany
• Practice - München, Bavaria, Germany
• Practice - Würzburg, Bavaria, Germany
• Medical Car Centre - Aschaffenburg, Bayer, Germany
• Medical Care Centre - Potsdam, Brandenburg, Germany
• Practice - Celle, Lower Saxony, Germany
• Medical Care Centre - Goslar, Lower Saxony, Germany
• Practice - Göttingen, Lower Saxony, Germany
• Medical Practice - Hanover, Lower Saxony, Germany
• Practice - Hanover, Lower Saxony, Germany
• Practice - Leer, Lower Saxony, Germany
• Clinic - Weißenfels, Lower Saxony, Germany
• Medical Practice - Wilhelmshaven, Lower Saxony, Germany
• Practice - Rostock, Mecklenburg-Vorpommern, Germany
• Practice - Rostock, Mecklenburg-Vorpommern, Germany
• Clinic - Rostock, Melcklenburg-Vorpommern, Germany
• Clinic - Aachen, North Rhine-Westphalia, Germany
• Clinic - Bochum, North Rhine-Westphalia, Germany
• Practice - Bonn, North Rhine-Westphalia, Germany
• Clinic - Bonn, North Rhine-Westphalia, Germany
• Practice - Bottrop, North Rhine-Westphalia, Germany
• Clinic - Essen, North Rhine-Westphalia, Germany
• Practice - Moers, North Rhine-Westphalia, Germany
• Medical Care Centre - Mönchengladbach, North Rhine-Westphalia, Germany
• Medical Care Centre - Mülheim, North Rhine-Westphalia, Germany
• Medical Care Centre - Neuss, North Rhine-Westphalia, Germany
• Clinic - Paderborn, North Rhine-Westphalia, Germany
• Medical Care Centre - Porta Westfalica, North Rhine-Westphalia, Germany
• Practice - Stolberg, North Rhine-Westphalia, Germany
• Practice - Troisdorf, North Rhine-Westphalia, Germany
• Clinic - Wuppertal, North Rhine-Westphalia, Germany
• Practice - Bad Kreuznach, Rhineland-Palatinate, Germany
• Practice - Kaiserslautern, Rhineland-Palatinate, Germany
• Practice - Worms, Rhineland-Palatinate, Germany
• Clinic - Saarbrücken, Saarland, Germany
• Practice - Dresden, Saxony, Germany

Showing 60 of 70 listed sites. See the official record for the complete list.