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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04489433
Status
No Longer Available

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 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 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.

Key Dates

Status verified
Dec 2025

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