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UK ENcorafenib and BInimetinib Real-world Study in Melanoma

RECRUITINGSponsored by Pierre Fabre Ltd
Actively Recruiting
SponsorPierre Fabre Ltd
Started2025-07-31
Est. completion2028-01-13
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

This is a prospective longitudinal multi-centre observational study conducted in the United Kingdom, in patients with metastatic cutaneous BRAF V600 mutation-positive melanoma assigned to receive encorafenib and binimetinib. The aim of this study is to learn about how encorafenib and binimetinib perform, patients' experiences of using them, and how they might affect patient's quality of life, in the real world, when these treatments are prescribed by doctors instead of in a clinical trial. Participants will complete electronic data entry via questionnaires over a 24-month period. Site research teams will also complete electronic data entry using participants' medical records over a 24-month period.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion criteria:

* Aged 18 years or older
* Willing and capable of providing written informed consent
* Access to a smartphone
* Diagnosis of metastatic cutaneous melanoma with presence of BRAF V600 mutation in tumour tissue prior to enrolment
* Clinical decision has been made to begin encorafenib plus binimetinib treatment in accordance with current Summary of Product Characteristics
* Encorafenib plus binimetinib to be prescribed as second-line treatment for BRAF V600-mutant metastatic melanoma

Exclusion criteria:

* Patients receiving systemic treatment for any tumours other than melanoma
* Patients participating in a clinical trial

Conditions2

CancerMetastatic Melanoma, BRAF V600 Mutation Positive

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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