Compassionate Use Program to Access Trametinib and Dabrafenib for Patients With BRAF Mutation-positive Metastatic Melanoma

Inclusion criteria

• . Has or is willing to give consent to the Treating Physician in accordance with the local regulatory requirements, with age at the time of consent ≥18 years.
• . Has confirmed BRAF V600 or other BRAF activating mutation-positive metastatic melanoma. Histologically Stage IIIC (unresectable) or Stage IV (metastatic) cutaneous melanoma with confirmed BRAF V600E/K positive mutation.
• . All clinical trials that the patient might qualify for have been ruled out.
• . Is receiving care at a clinical site with a Treating Physician who has experience with administering investigational agents for the end-stage melanoma population, or the patient is willing and/or able to travel to a site and receive treatment under the guidance of physician with this experience. NOTE: The latter option would require the patient being evaluated in advance by the Treating Physician at the experienced site and his/her agreement to assume responsibility for the care of the patient.
• . Is able to retain oral medication and swallow tablets/capsules (appropriate exceptions allowed for patients who are unable to swallow tablets/capsules - this is subject to availability of alternative (liquid) oral formulations).
• . Does not require treatment with any (other) anti-cancer medication (exceptions might be allowed and are subject to individual evaluation).
• . For patients with active brain metastases: the patient does not require or is ineligible for immediate local treatment.
• . Is not eligible for participation in any of the IMP's ongoing clinical trials or has recently completed a clinical trial that has been terminated and, after considering other options (e.g., trial extensions, amendments, etc.), the clinical team has determined that treatment is necessary and there are no other feasible alternatives for the patient.