Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT04673955

Recruiting

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

Observational

Phase not listed

Hospital

Sponsor: Pierre Fabre

Last Updated: September 29, 2022
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Show Detailed Description

Treatment Category

Monoclonal Antibodies, Targeted Therapy

Required Mutations

BRAF

Trial Started

September 3, 2020

Last Updated by Sponsor

September 29, 2022

Estimated Completion

September 1, 2026

Contact Study

Name:Marion Schmoll

Email:marion.schmoll@iomedico.com

Phone:+4976115242627

Name:Frank Reichenbach, Dr. rer. nat

Email:frank.reichenbach@pierre-fabre.com

Phone:+4976145261846

Eligibility

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).

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Design Details

AllocationN/A

Intervention ModelN/A

MaskingN/A

Number to Enroll500

Arms & Interventions

Arms

Interventions

No interventions available.

Outcome Measures

Primary Outcome Measures

Overall SurvivalAt 12 months after start of treatment

Overall Survival rate

Secondary Outcome Measures

Patient and disease profiles at start of treatment with encorafenib plus cetuximabBaseline

Demographic and disease chracteristics

BRAF-mutation assessmentBaseline

Date and type of BRAFV600E testing

Type and sequence of treatments before and after encorafenib plus cetuximabThrough study completion, an average of 17 months

Treatment sequence prior to and after encorafenib plus cetuximab

Characteristics of treatment with encorafenib plus cetuximabThrough encorafenib plus cetuximab treatment completion, an average of 9 months

Evaluation of reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other)