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Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment | Clinical Trials | Clareo Health

RECRUITING

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Encorafenib Plus Binimetinib in Patients With Locally Advanced, Unresectable or Metastatic BRAFV600-mutated Melanoma: a Multi-centric, Multinational, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland - BERING MELANOMA

NCT04045691•Pierre Fabre Pharma GmbH

View on ClinicalTrials.gov

Summary

BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study - investigates real-world effectiveness, quality of life, safety and tolerability of encorafenib plus binimetinib in unresectable advanced or metastatic BRAF(Rapidly Accelerated Fibrosarcoma isoform B)-V600-mutant malignant melanoma after commercial availability of these two products in Germany, Austria and Switzerland. The study focusses on the documentation of the first and second line setting (i.e. after one line of prior checkpoint inhibition) by documenting patients treated according to the SmPC (Summary of Product Characteristics).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent of the patient with regard to the pseudonymized documentation as well as the transfer and processing of his/her data within the study and the ADOREG \[Cancer Registry of German Working Group of Dermato-Oncology\] registry (data transfer to ADOREG registry only for patients from German sites);
•Legally capable male or female patient ≥ 18 years of age (no upper limit);
•Decision was taken to treat the patient with encorafenib plus binimetinib in accordance with the current SmPC \[Summary of Product Characteristics\] and by prescription; this decision was taken prior to and independent from the inclusion into the study;
•Treatment with encorafenib plus binimetinib has been started ≤ 6 months prior to providing written informed consent for this study or is planned to be started in the near future;
•Unresectable advanced or metastatic malignant melanoma with BRAF \[Rapidly Accelerated Fibrosarcoma isoform B\] V600 mutation;
•Treatment-naive or after one prior line of checkpoint inhibitor treatment (anti-CTLA4 \[Cytotoxic T-Lymphocyte Antigen-4\] and/or anti-PD(L)1 \[Programmed cell Death protein 1\]) in the unresectable advanced or metastatic setting.

Exclusion Criteria

•Previous treatment with a BRAF- and/or MEK \[Mitogen-Activated Protein/Extracellular-signal Regulated Kinase\]- inhibitor except for:
•\-- prior adjuvant treatment with BRAF+MEK-inhibitor combination therapy that ended \> 6 months prior start of Encorafenib/Binimetinib treatment;
•More than one prior line of checkpoint inhibitor treatment in the unresectable advanced or metastatic setting;
•Any previous chemotherapeutic treatment of the melanoma disease;
•Presence of any contraindication with regard to the encorafenib-binimetinib-treatment 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 melanoma;
•Prisoners or persons who are compulsorily detained (involuntarily incarcerated).

Locations (59)

Graz, Austria

Innsbruck, Austria

Klagenfurt, Austria

Linz, Austria

Salzburg, Austria

Vienna, Austria

Wiener Neustadt, Austria

Ahaus, Germany

Key Dates

Start Date

October 17, 2019

Primary Completion Date

December 1, 2026

Completion Date

September 1, 2027

Last Updated

January 19, 2021

Enrollment

750

ESTIMATED participants

Conditions

Melanoma Stage IVMelanoma Stage III

Interventions

Encorafenib

DRUG

Binimetinib

DRUG

Contacts

Christian A Rosé, MD

CONTACT

+49 761 45261 bering_de@pierre-fabre.com

Andrea Schmidt, MSc

CONTACT

+49 641 94436 ansc@alcedis.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

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