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

  • STATUS
    Recruiting
  • End date
    Sep 28, 2026
  • participants needed
    500
  • sponsor
    Pierre Fabre Pharma GmbH
Updated on 28 January 2021

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 and Austrian routine setting.

Details
Condition Metastatic Colorectal Carcinoma
Treatment Cetuximab, Encorafenib
Clinical Study IdentifierNCT04673955
SponsorPierre Fabre Pharma GmbH
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Metastatic Colorectal Carcinoma??
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)
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