Trametinib + Ceritinib for Melanoma
Trial Summary
Will I have to stop taking my current medications?
You may need to stop taking certain medications before joining the trial. Specifically, you must stop medications that affect the heart's rhythm, certain enzyme-affecting drugs, warfarin, unstable doses of corticosteroids, and some anticonvulsants at least one week before starting the trial.
What data supports the effectiveness of the drug combination Trametinib and Ceritinib for treating melanoma?
Research shows that combining Trametinib with Ceritinib can effectively inhibit tumor growth in certain types of melanoma that lack common mutations, by targeting specific cellular pathways. Additionally, Trametinib has been shown to improve survival in melanoma patients when used with other drugs.12345
What safety information is available for Trametinib in combination therapies?
Trametinib, when used in combination with other drugs like dabrafenib, has been shown to have a manageable safety profile, though it can cause side effects such as fever, fatigue, and nausea. These side effects have been effectively managed in patients with melanoma, suggesting that the combination can be safe with proper monitoring and management.12678
How is the drug combination of Trametinib and Ceritinib unique for treating melanoma?
Trametinib is a MEK inhibitor that targets a specific pathway in melanoma cells, often used in combination with other drugs like dabrafenib to improve effectiveness and delay resistance. The combination with Ceritinib, which is typically used for lung cancer, may offer a novel approach by targeting different pathways, potentially enhancing treatment efficacy for melanoma.127910
What is the purpose of this trial?
The main purpose of this study is to determine the risks and benefits of ceritinib (ZYKADIA) given in combination with trametinib (MEKINIST) in patients who have progressed on prior melanoma therapy.
Research Team
Zeynep Eroglu, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria
This trial is for adults with advanced melanoma that can't be surgically removed and who have already tried certain therapies without success. They must be in relatively good health, able to use birth control, and have tumors measurable by standard criteria. People with severe allergies to the drugs' ingredients, uncontrolled brain metastases, recent heart issues, or those on conflicting medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive trametinib and ceritinib in 4-week cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ceritinib
- Trametinib
Ceritinib is already approved in United States for the following indications:
- High-risk neuroblastoma in the bone or bone marrow
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Novartis Pharmaceuticals
Industry Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD