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

NCT04489433 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-12-18

No results posted yet for this study

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.

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
18 Years
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 NCT04489433 on ClinicalTrials.gov