NCT04673955 BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment
| NCT ID | NCT04673955 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pierre Fabre Pharma GmbH |
| Condition | Metastatic Colorectal Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-09-03 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2020-09-03 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04673955 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Colorectal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04673955 currently recruiting?
Yes, NCT04673955 is actively recruiting participants. Contact the research team at marion.schmoll@iomedico.com for enrollment information.
Where is the NCT04673955 trial being conducted?
This trial is being conducted at Braunau am Inn, Austria, Linz, Austria, Feldkirch, Austria, Vienna, Austria and 11 additional locations.
Who is sponsoring the NCT04673955 clinical trial?
NCT04673955 is sponsored by Pierre Fabre Pharma GmbH. The trial plans to enroll 500 participants.