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

NCT04673955 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-09-29

No results posted yet for this study

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

Interventions

DRUG

Encorafenib

Observation of real-life treatment with encorafenib and cetuximab

DRUG

Cetuximab

Observation of real-life treatment with encorafenib and cetuximab

Sponsors & Collaborators

  • iOMEDICO AG

    collaborator INDUSTRY

  • Pierre Fabre Pharma AG

    collaborator INDUSTRY

  • Pierre Fabre Pharma Austria

    collaborator UNKNOWN

  • Pierre Fabre Pharma GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2026-09-30
Completion
2027-01-31

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673955 on ClinicalTrials.gov