Dabrafenib + Trametinib Before and After Surgery for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dabrafenib and trametinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving dabrafenib and trametinib after surgery may kill any remaining tumor cells.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it mentions that you cannot use certain prohibited medications during the study. It's best to discuss your current medications with the trial team to see if any are prohibited.
Is the combination of Dabrafenib and Trametinib generally safe for humans?
How is the drug combination of Dabrafenib and Trametinib unique for treating melanoma?
The combination of Dabrafenib and Trametinib is unique because it targets the MAPK pathway, specifically inhibiting mutant BRAF and MEK proteins, which helps improve survival in patients with BRAF-mutant melanoma. This combination is used both before and after surgery to enhance treatment outcomes, offering a novel approach compared to traditional chemotherapy.678910
What data supports the effectiveness of the drug Dabrafenib + Trametinib for melanoma?
Who Is on the Research Team?
Rodabe N. Amaria
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with stage IIIB-C melanoma that can be removed by surgery and have a BRAF V600 mutation. Participants must be fit for surgery, not on current cancer treatments, able to consent, and meet specific health criteria including blood counts. Women of childbearing potential and men must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive dabrafenib and trametinib orally for 8 weeks before surgery
Surgery
Participants undergo surgery to remove the tumor
Adjuvant Treatment
Participants receive dabrafenib and trametinib orally for 44 weeks after surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dabrafenib
- Therapeutic Conventional Surgery
- Trametinib
Dabrafenib is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator