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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04544202
Status
No Longer Available

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib and Trametinib — DRUG
    The starting dose of the combination treatment will be administered as follows: * Dabrafenib, 150 mg, twice daily (BID); * Trametinib, 2.0 mg, once daily (QD)
  • Dabrafenib — DRUG
    If administration of dabrafenib is interrupted or permanently discontinued, administration of trametinib may continue.
  • Trametinib — DRUG
    If administration of trametinib is interrupted or permanently discontinued, administration of dabrafenib may be continued.

Study Details

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.

Key Dates

Status verified
Nov 2024

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