Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. (NCT05270044)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Pre-Screening
2. Male or female ≥ 18 years of age;
3. Surgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;
4. Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.
5. Sentinel node (SN) staged node negative (pN0);
6. Available tumour sample for central determination of the BRAF V600E/K mutation. Screening
7. Melanoma confirmed centrally to be BRAF V600E/K mutation-positive;
8. Participant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);
9. No more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;
10. Recovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);
11. ECOG performance status of 0 or 1;
12. Adequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin ≥ 9.0 g/dL;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (155 Sites)

• Centro Oncologico Korben — CABA, Buenos Aires
• Centro de Investigaciones Medicas Mar del Plata — Mar del Plata, Buenos Aires
• Fundacion CIDEA — Ciudad Autonoma Bs As, Ciudad Autonoma Buenos Aires
• Sanatorio Britanico S.A. — Rosario, Santa Fe Province
• Instituto de Oncologia de Rosario — Rosario, Santa Fe Province
• Hospital Aleman — Ciudad Autonoma Buenos Aires,
• Instituto Medico Especializado Alexander Fleming — Ciudad Autonoma Buenos Aires,
• Clinica Adventista Belgrano — Ciudad Autonoma Buenos Aires,
• Westmead Hospital — Sydney, New South Wales
• Melanoma Institute Australia — Wollstonecraft, New South Wales
• Princess Alexandra Hospital — Woolloongabba, Queensland
• Adelaide Oncology & Haematolog, Calvary North Adelaide Hospital — North Adelaide, South Australia
• Box Hill Hospital — Box Hill, Victoria
• Austin Health — Heidelberg, Victoria
• The Alfred Hospital — Prahran, Victoria
• Hollywood Private Hospital — Nedlands, Western Australia
• Sir Charles Gairdner Hospital — Nedlands, Western Australia
• Landeskrankenhaus - Universitaetsklinikum Graz — Graz,
• Krankenhaus der Elisabethinen Linz — Linz,
• Universitätsklinikum St.Pölten-Lilienfeld — Sankt Pölten,
• AKH - Medizinische Universität Wien — Vienna,
• Institut Jules Bordet — Anderlecht,
• ZNA Middelheim — Antwerp,
• Universitair Ziekenhuis Brussel — Brussels,
• Cliniques Universitaires Saint-Luc — Brussels,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.