Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection

Inclusion Criteria:

1. Has or is willing to give consent to the Treating Physician in accordance with the local regulatory requirements.

2. Has the following diagnosis: Completely resected (R0) histologically confirmed high-risk (stage III) cutaneous melanoma with confirmed BRAF V600E/K activating mutation.

   Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible. Patients with an unknown primary melanoma are not eligible.

3. All clinical trials that the patient might qualify for have been ruled out.
4. Is receiving care at a clinical site with a Treating Physician who has experience with administering investigational agents for patients with this condition, or the patient is willing and/or able to travel to a site and receive treatment under the guidance of physician with this experience.
5. 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).
6. Does not require treatment with any (other) anti-cancer medication while on the Managed Access Program (exceptions might be allowed and are subject to individual evaluation).
7. For patients with active brain metastases: the patient does not require or is ineligible for immediate local treatment.
8. 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.

Exclusion Criteria:

1. Uveal or mucosal melanoma.
2. Evidence of metastatic disease including in-transit metastasis.
3. Female who is pregnant or nursing (patient must discontinue nursing in order to enroll in the program).
4. Patients who have any lab abnormalities
5. Patients who have received prior therapy with a BRAF inhibitor other than dabrafenib.
6. Current evidence of cardiovascular risk.
7. Known history for testing positive for Human Immunodeficiency Virus (HIV).
8. Not able to understand and to comply with treatment instructions and requirements.

Other protocol-defined inclusion/exclusion criteria may apply at the end.