Compassionate Use Program for Trametinib and Dabrafenib in Patients with BRAF Mutation-positive Metastatic Melanoma

Sponsor: Novartis Pharmaceuticals

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04489433

Provider View

This program allows patients with BRAF mutation-positive metastatic melanoma to access the drugs trametinib and dabrafenib. It is designed for patients who cannot participate in clinical trials and need these medications before they are widely available.

Patient Parameters

Program Overview

The program provides access to trametinib and dabrafenib for patients with metastatic melanoma that has a specific BRAF mutation. It is intended for those who cannot join clinical trials and need these drugs before they are commercially available. The program will continue until the drugs are available in all participating countries, alternative treatments are found, or if there are changes in the drug's safety or effectiveness.

Description

Patients' doctors must follow treatment guidelines and local health regulations. Doctors request access to the drugs from Novartis, which reviews and approves the request. The program will provide access until the drugs are available in all participating countries, alternative treatments are found, or if there are changes in the drug's safety or effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to give consent.
  • Have confirmed BRAF V600 or other BRAF mutation-positive metastatic melanoma.
  • Cannot join any clinical trials for their condition.
  • Must be treated by a doctor experienced with these drugs or willing to travel to such a doctor.
  • Able to take oral medication.
  • Not needing other anti-cancer medications.
  • If brain metastases are present, they must not need immediate local treatment.
  • Not eligible for ongoing clinical trials or have completed a terminated trial with no other options.
  • ECOG performance status of 0 to 3 and stable condition.
  • Not needing prohibited medications.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.

Exclusion Criteria

  • Have uveal or mucosal melanoma.
  • Pregnant or nursing women.
  • Have severe lab abnormalities or side effects.
  • Receiving other systemic anti-cancer therapies, except for specific brain treatments.
  • Previously treated with a BRAF inhibitor other than dabrafenib.
  • Have a malignancy with a RAS mutation.
  • Allergic to trametinib, dabrafenib, or related substances.
  • Have medical conditions that increase risk of adverse outcomes.
  • Have eye conditions like retinal vein occlusion.
  • Have significant heart problems or risks.
  • Unable to understand or follow treatment instructions.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.