NO_LONGER_AVAILABLENot Applicable

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

Plain-language summary

The purpose of this Treatment Plan is to allow access to trametinib and dabrafenib for eligible high-risk BRAF mutation-positive patients in the adjuvant treatment of melanoma after surgical resection. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

Who can participate

Age range1 Year – 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.
✓. Has the following diagnosis: Completely resected (R0) histologically confirmed high-risk (stage III) cutaneous melanoma with confirmed BRAF V600E/K activating 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 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.
✓. 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).
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3 (or equivalent) and is in stable clinical condition. NOTE: patient in rapidly deteriorating clinical condition prior to start of therapy should not be considered for this program.
✓. Does not require treatment with prohibited concomitant medications (please refer to the IB or approved label/SmPC).

Exclusion criteria

✕. Uveal or mucosal melanoma.
✕. Evidence of metastatic disease.
✕. 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 surgery (other exceptions might be allowed and are subject to individual evaluation). 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.
✕. 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 IDNCT04544202

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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