NO_LONGER_AVAILABLENot Applicable

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

Plain-language summary

The purpose of this Cohort Treatment Plan is to allow access to trametinib (monotherapy or in combination) and dabrafenib (monotherapy or in combination) for eligible patients diagnosed with metastatic melanoma BRAF mutation-positive.

Who can participate

Age range18 Years – 100 Years

SexALL

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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.

Exclusion criteria

✕. Uveal or mucosal melanoma.
✕. Female who is pregnant or nursing (patient must discontinue nursing in order to enroll in the program).
✕. Patients who have any lab abnormalities or AE/SAEs greater than Grade 3 (CTCAE v5.0)
✕. Concurrent treatment with other systemic anti-cancer therapies is not allowed, with the exception of whole brain radiation and brain radiosurgery. Patients who are currently being treated with another systemic anti-cancer therapy (e.g., chemotherapy, immune, biologic, or targeted therapy) must discontinue use prior to initiation of treatment with trametinib and dabrafenib. NOTE: Radiation skin injury has been reported with concurrent use of dabrafenib and radiation. All AEs/SAEs related to WBRT (whole brain radiation) or brain radiosurgery are required to resolve to Grade 1 or less (CTCAE v5.0) prior to start of the Managed Access Program treatment.
✕. Patients who have received prior therapy with a BRAF inhibitor other than dabrafenib.
✕. Presence of any malignancy with confirmed activating RAS mutation. NOTE: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility.
✕. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib or dabrafenib, or excipients or to dimethyl sulfoxide (DMSO).
✕. Any medical conditions or physical examination or clinical laboratory findings which would put the patient at high risk for an adverse outcome.

Trial details

NCT IDNCT04489433

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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