(Neo)Adjuvant BRAF/MEK Inhibition in pN1c Melanoma

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

Phase 2 open-label single arm intervention study administering encorafenib/binimetinib in neo-adjuvant setting followed by surgery and subsequent adjuvant encorafenib/binimetinib in patients diagnosed solely with in-transit metastatic melanoma. Primary objective is to determine the efficacy of neo-adjuvant encorafenib/binimetinib as measured by pathological response rate (partial-, complete- and no response). In the biopsy at week 0 the viability will be judged and will be graded according to the amount of tumor necrosis: >50% tumor necrosis with <50% viable tumor cells, <50% necrosis with >50% viable tumor cells and 100% necrosis without viable tumor cells. Partial response is defined as a decrease of at least 50% of the viable tumor cells and complete response as 100% decrease of tumor cells, whereas no response is defined as more than 50% of viable tumor cells present. Secondary objectives are to assess efficacy of adjuvant BRAF/MEK inhibition, measured as local recurrence free survival (LRFS), distant metastases-free survival (DFMS), recurrence free survival (local and/or distant recurrence, RFS) and overall survival (OS). Additionally, the toxicity of the administered regimen will be assessed by analyzing the frequency- and type of adverse events, and occurrences of therapy interruption, dose reduction and or therapy cessation. Moreover, an exploration of drug measurements and ctDNA in blood and additional research of biopsies / resections will be done. ;

Study Design

Related Conditions & MeSH terms

In-Transit Metastasis of Cutaneous Melanoma
Melanoma
Melanoma Stage III
Neoplasm Metastasis

Clinical Trial Details

NCT number	NCT05767879
Study type	Interventional
Source	Leiden University Medical Center
Contact	HW Kapiteijn, phd
Phone	0715264036
Email	h.w.kapiteijn@lumc.nl
Status	Recruiting
Phase	Phase 2
Start date	January 1, 2022
Completion date	January 1, 2026

View Details

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