Drug Combinations for Advanced Melanoma
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain treatments like corticosteroids or immunosuppressive medications, you may need to adjust or stop them before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Dabrafenib and Trametinib for advanced melanoma?
Is the combination of dabrafenib and trametinib safe for humans?
The combination of dabrafenib and trametinib is generally considered safe, with most patients experiencing mild to moderate side effects that can be managed with dose adjustments. However, some serious side effects like heart issues and high fever can occur, so it's important to monitor and manage these during treatment.25678
How is the drug combination of Dabrafenib, Encorafenib, Nivolumab, and Trametinib unique for treating advanced melanoma?
This drug combination is unique because it combines BRAF and MEK inhibitors (Dabrafenib, Encorafenib, and Trametinib) with an immune checkpoint inhibitor (Nivolumab), potentially addressing both tumor growth and immune system activation, which may improve outcomes in patients with advanced melanoma.49101112
What is the purpose of this trial?
This phase II trial studies the side effects and how well nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib work in treating patients with BRAF-mutated stage III-IV melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Trametinib, dabrafenib, encorafenib, and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib may work better in treating patients with BRAF-mutated melanoma.
Research Team
Hussein A. Tawbi
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with stage III-IV melanoma that's spread or can't be surgically removed, specifically those with a BRAF V600 mutation. It includes patients who've had prior treatments except for BRAFi/MEKi and requires stable brain metastases if present. Participants must have good organ function, not need high steroid doses, and agree to contraception.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive nivolumab, dabrafenib, and trametinib or encorafenib and binimetinib in cycles of 28 days for up to 3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Dabrafenib
- Encorafenib
- Laboratory Biomarker Analysis
- Nivolumab
- Pharmacological Study
- Trametinib
Dabrafenib is already approved in European Union, United States, Canada, Japan for the following indications:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
- Unresectable or metastatic melanoma with a BRAF V600E mutation
- Adjuvant treatment of melanoma with a BRAF V600E or V600K mutation
- Metastatic non-small cell lung cancer with a BRAF V600E mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
- Adjuvant treatment of melanoma with a BRAF V600 mutation
- Unresectable or metastatic melanoma with a BRAF V600 mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator