NCT04045691

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: Pierre Fabre Pharma GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Melanoma Stage IV
• Melanoma Stage III

Interventions

Type	Name	Description
DRUG	Encorafenib	Observation of real-life treatment with encorafenib and binimetinib
DRUG	Binimetinib	Observation of real-life treatment with encorafenib and binimetinib

Timeline

• Start date: 2019-10-17
• Primary completion: 2026-12-01
• Completion: 2027-09-01
• First posted: 2019-08-05
• Last updated: 2021-01-19

Locations

59 sites across 3 countries: Austria, Germany, Switzerland