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

NCT04544202 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Eligibility

Min Age
1 Year
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04544202 on ClinicalTrials.gov