RecruitingNCT04673955

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

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

Sponsor

Pierre Fabre Pharma GmbH

Enrollment

500 participants

Start Date

Sep 3, 2020

Study Type

OBSERVATIONAL

Conditions

Metastatic Colorectal Carcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on patients with a specific type of colorectal cancer — BRAF V600E mutated metastatic colorectal cancer — who are being treated with a targeted drug combination (encorafenib and cetuximab). Researchers want to understand how this treatment performs in everyday clinical practice, outside of a controlled trial setting. **You may be eligible if you:** - Are 18 years of age or older - Have metastatic colorectal cancer with the BRAF V600E mutation - Have already received prior systemic therapy - Have been prescribed encorafenib plus cetuximab by your treating oncologist (this decision must be made before joining the study) - Treatment must have started no more than 3 months before enrolling in the study **You may NOT be eligible if you:** - Do not have the BRAF V600E mutation - Have not received any prior systemic treatment - Are not being treated with encorafenib and cetuximab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEncorafenib

Observation of real-life treatment with encorafenib and cetuximab

DRUGCetuximab

Observation of real-life treatment with encorafenib and cetuximab

Locations(70)

Clinic

Braunau am Inn, Upper Austria, Austria

Clinic

Linz, Upper Austria, Austria

Clinic

Feldkirch, Voralberg, Austria

Clinic

Vienna, Austria

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

Prctice

Naunhof, Saxony, Germany

Clinic

Torgau, Saxony, Germany

Practice

Halle, Saxony-Anhalt, Germany

Clinic

Köthen, Saxony-Anhalt, Germany

Practice

Köthen, Saxony-Anhalt, Germany

Clinic

Flensburg, Schleswig-Holstein, Germany

Clinic

Eisenach, Thuringia, Germany

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

Private Practice

Würzburg, Germany

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NCT04673955

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