Official Title
Managed Access Program (MAP) to Provide Access to Trametinib and Dabrafenib, for Patients With BRAF Mutation-positive Metastatic Melanoma
Brief 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.

Detailed Description

The patient's Treating Physician should follow the suggested treatment guidelines and comply

with all local health authority regulations.



The requesting Treating Physician submitted a request for access to drug (often referred to

as Compassionate Use) to Novartis which was reviewed and approved by the medical team

experienced with the drug and indication.



This program will provide access to patients until:



- All participating countries have received marketing authorization and product is

commercially available and accessible to all participating patient(s) or



- Alternative treatment options are available and/or



- In case of changes in the safety profile or a lack of overall efficacy of the product.

Available
Treatment IND/Protocol
Melanoma

Drug: Dabrafenib and Trametinib
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)

Drug: Dabrafenib
If a dose reduction below 50 mg BID for dabrafenib is required, dabrafenib will be permanently discontinued, but the patient will be allowed to continue trametinib.

Drug: Trametinib
If a dose reduction below 1.0 mg once daily for trametinib is required, then trametinib will be permanently discontinued, but the patients will be allowed to continue dabrafenib.

Eligibility Criteria

This program is no longer accepting new patients

Eligibility Gender
All
Eligibility Age
Maximum: 100 Years
Contacts

Novartis Pharmaceuticals
+41613241111
novartis.email@novartis.com

Novartis Pharmaceuticals

Novartis Pharmaceuticals
NCT Number
Keywords
Metastatic melanoma
melanoma
Stage IV melanoma
Cutaneous
Mucosal
Ocular
Dabrafenib
Trametinib
DRB436
TMT212
Compassionate Use
cohort
Expanded Access
MeSH Terms
Melanoma
Trametinib
Dabrafenib
Intervention Name
Dabrafenib and Trametinib
Dabrafenib
Trametinib