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

NCT04673955 | Recruiting

• 1 other identifier: NIS-PFO-2020-3101
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 70

Brief 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.

Conditions

Metastatic Colorectal Carcinoma

Keywords

BRAFV600E mutation

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall Survival rate

  At 12 months after start of treatment

Secondary Outcomes (20)

• Patient and disease profiles at start of treatment with encorafenib plus cetuximab

  Baseline

• BRAF-mutation assessment

  Baseline

• Type and sequence of treatments before and after encorafenib plus cetuximab

  Through study completion, an average of 17 months

• Characteristics of treatment with encorafenib plus cetuximab

  Through encorafenib plus cetuximab treatment completion, an average of 9 months

• Effectiveness of treatment with encorafenib and cetuximab

  Through encorafenib plus cetuximab treatment completion, an average of 9 months

Interventions

Encorafenib DRUG

Observation of real-life treatment with encorafenib and cetuximab

Also known as: Braftovi

Cetuximab DRUG

Observation of real-life treatment with encorafenib and cetuximab

Also known as: Erbitux

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with metastatic, BRAFV600E-mutant, colorectal carcinoma, who have received prior systemic therapy, with the decision to receive the doublet therapy encorafenib plus cetuximab according to the current SmPC.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pierre Fabre Pharma GmbH: lead
• iOMEDICO AG: collaborator
• Pierre Fabre Pharma AG: collaborator
• Pierre Fabre Pharma Austria: collaborator

Study Sites (70)

Clinic

Braunau am Inn, Upper Austria, 5280, Austria

RECRUITING

Clinic

Linz, Upper Austria, 4010, Austria

RECRUITING

Clinic

Feldkirch, Voralberg, 6807, Austria

RECRUITING

Clinic

Vienna, 1090, Austria

RECRUITING

Practice

Offenburg, Baden-Wurttemberg, 77654, Germany

RECRUITING

Medical Care Centre

Ulm, Baden-Wurttemberg, 89073, Germany

RECRUITING

Clinic

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Practice

Augsburg, Bavaria, 86150, Germany

RECRUITING

Practice

Donauwörth, Bavaria, 86609, Germany

RECRUITING

Clinic

Erlangen, Bavaria, 91054, Germany

RECRUITING

Practice

München, Bavaria, 81241, Germany

RECRUITING

Practice

Würzburg, Bavaria, 97080, Germany

RECRUITING

Medical Car Centre

Aschaffenburg, Bayer, 63739, Germany

RECRUITING

Medical Care Centre

Potsdam, Brandenburg, 14467, Germany

RECRUITING

Practice

Celle, Lower Saxony, 29221, Germany

RECRUITING

Medical Care Centre

Goslar, Lower Saxony, 38642, Germany

RECRUITING

Practice

Göttingen, Lower Saxony, 37073, Germany

RECRUITING

Medical Practice

Hanover, Lower Saxony, 30161, Germany

RECRUITING

Practice

Hanover, Lower Saxony, 30161, Germany

RECRUITING

Practice

Leer, Lower Saxony, 26789, Germany

RECRUITING

Clinic

Weißenfels, Lower Saxony, 26121, Germany

RECRUITING

Medical Practice

Wilhelmshaven, Lower Saxony, 26389, Germany

RECRUITING

Practice

Rostock, Mecklenburg-Vorpommern, 18057, Germany

RECRUITING

Practice

Rostock, Mecklenburg-Vorpommern, 18107, Germany

RECRUITING

Clinic

Rostock, Melcklenburg-Vorpommern, 18059, Germany

RECRUITING

Clinic

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Clinic

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

Practice

Bonn, North Rhine-Westphalia, 53123, Germany

RECRUITING

Clinic

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Practice

Bottrop, North Rhine-Westphalia, 46236, Germany

RECRUITING

Clinic

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Practice

Moers, North Rhine-Westphalia, 47441, Germany

RECRUITING

Medical Care Centre

Mönchengladbach, North Rhine-Westphalia, 41239, Germany

RECRUITING

Medical Care Centre

Mülheim, North Rhine-Westphalia, 45468, Germany

RECRUITING

Medical Care Centre

Neuss, North Rhine-Westphalia, 41462, Germany

RECRUITING

Clinic

Paderborn, North Rhine-Westphalia, 33098, Germany

RECRUITING

Medical Care Centre

Porta Westfalica, North Rhine-Westphalia, 32457, Germany

RECRUITING

Practice

Stolberg, North Rhine-Westphalia, 52222, Germany

RECRUITING

Practice

Troisdorf, North Rhine-Westphalia, 53840, Germany

RECRUITING

Clinic

Wuppertal, North Rhine-Westphalia, 42283, Germany

RECRUITING

Practice

Bad Kreuznach, Rhineland-Palatinate, 55543, Germany

RECRUITING

Practice

Kaiserslautern, Rhineland-Palatinate, 67655, Germany

RECRUITING

Practice

Worms, Rhineland-Palatinate, 67547, Germany

RECRUITING

Clinic

Saarbrücken, Saarland, 66113, Germany

RECRUITING

Practice

Dresden, Saxony, 01307, Germany

RECRUITING

Prctice

Naunhof, Saxony, 04683, Germany

RECRUITING

Clinic

Torgau, Saxony, 04860, Germany

RECRUITING

Practice

Halle, Saxony-Anhalt, 06110, Germany

RECRUITING

Clinic

Köthen, Saxony-Anhalt, 06366, Germany

RECRUITING

Practice

Köthen, Saxony-Anhalt, 06366, Germany

RECRUITING

Clinic

Flensburg, Schleswig-Holstein, 24939, Germany

RECRUITING

Clinic

Eisenach, Thuringia, 99817, Germany

RECRUITING

Hospital

Aschaffenburg, Germany

RECRUITING

Medical Care Centre

Berlin, 10407, Germany

RECRUITING

Practice

Berlin, 10707, Germany

RECRUITING

Practice

Berlin, 10715, Germany

RECRUITING

Clinic

Berlin, 12559, Germany

RECRUITING

Private Practice

Berlin, Germany

RECRUITING

Private Practice

Dresden, Germany

RECRUITING

Hospital

Esslingen am Neckar, Germany

RECRUITING

Practice

Hamburg, 10259, Germany

RECRUITING

Practice

Hamburg, 20259, Germany

RECRUITING

Private Practice

Heidelberg, Germany

RECRUITING

Private Practice

Leer, Germany

RECRUITING

Private Practice

Lübeck, Germany

RECRUITING

Private Practice

Naunhof, Germany

RECRUITING

Private Practice

Offenburg, Germany

RECRUITING

Private Practice

Oldenburg in Holstein, Germany

RECRUITING

Private Practice

Schorndorf, Germany

RECRUITING

Private Practice

Würzburg, Germany

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

encorafenib; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Marion Schmoll

CONTACT

+4976115242627; marion.schmoll@iomedico.com

Frank Reichenbach, Dr. rer. nat

CONTACT

+4976145261846; frank.reichenbach@pierre-fabre.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: December 17, 2020
• Study Start: September 3, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (66); AU (4)