NCT04544202

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

Managed Access Program (MAP) Cohort Treatment Plan CDRB436F2001CM to Provide Access to Trametinib and Dabrafenib Combination Therapy in the Adjuvant Treatment of High-risk BRAF 600 Mutation-positive Melanoma After Surgical Resection

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 1 Year – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Melanoma
• Adjuvant

Interventions

Type	Name	Description
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 administration of dabrafenib is interrupted or permanently discontinued, administration of trametinib may continue.
DRUG	Trametinib	If administration of trametinib is interrupted or permanently discontinued, administration of dabrafenib may be continued.

Timeline

• First posted: 2020-09-10
• Last updated: 2024-11-12