A two-arm, randomised trial investigating the response of encorafenib and binimetinib compared to standard adjuvant therapy.
A phase II, multi-centre, open label, randomised trial. The trial will assess the delivery, response rate, treatment compliance, efficacy and safety of encorafenib and binimetinib compared to standard adjuvant therapy in patients with BRAFV600 mutant clinically detected AJCC stage III(B/C/D) or oligometastatic stage IV Melanoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Encorafenib is a potent and highly selective ATP-competitive small molecule RAF kinase inhibitor, which suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, D and K). Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. Binimetinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity
Standard Adjuvant Treatment
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Pathological response rate
% of patients with a complete response using Haemotoxylin and Eosin staining of tumour removed at surgery.
Time frame: During scheduled surgery
Treatment compliance
Incidence of missed treatment doses assessed from number of tablets returned.
Time frame: Through study completion for an average of 12 months
Radiological response
% of patients with a complete response using CT scan tumour measurement assessment (RECIST) from start of treatment until 8 weeks.
Time frame: Through study completion for an average of 12 months
Toxicity of treatment
Rate of patients with drug related toxicities reported from start of study until end of treatment
Time frame: Through study completion for an average of 12 months
Lymphoedema toxicity
Incidence of lymphoedema toxicity using circumferential limb measurement and questionnaires for an average of 12 months.
Time frame: Through study completion for an average of 12 months
Survival rate
Number of patients deceased from start of treatment for an average of 12 months.
Time frame: Through study completion for an average of 12 months
Quality of life
Quality of life assessed by Functional Assessment of Cancer Therapy - Melanoma (FACT-M) questionnaire for an average of 12 months.
Time frame: Through study completion for an average of 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Recruitment rate
Rate of monthly recruitment achieved during the last 6 months of the trial recruitment period
Time frame: Through study completion for an average of 12 months