Trial with melanoma patients who are treated with dabrafenib and trametinib to make the tumor smaller, so it can be surgically removed.
Recruiting
- Conditions
- Stage III-IV Melanoma
- Registration Number
- NL-OMON25911
- Lead Sponsor
- Antoni van Leeuwenhoek ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1.Has provided signed informed consent.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Known ocular or primary mucosal melanoma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0 resection.
- Secondary Outcome Measures
Name Time Method Recurrence free survival; time-to-next treatment, overall survival. <br><br /><br /><br>Objectives translational research: <br>To investigate treatment induced changes in exome mutations within the tumor, changes in gene expression profiles and development of gene signatures for response to treatment, target protein inhibition (levels of pMEK, pERK, pAKT) and IHC for lymphocytic infiltrates and expression of PD-L1, Gata-3, IDO etc.)<br /><br>To perform patient derived xenografting (PDX) in immunodeficient mice to investigate development of resistance.