Trametinib + Ceritinib for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two drugs, trametinib and ceritinib, to evaluate their joint effectiveness for people with advanced melanoma (a type of skin cancer) that has not responded well to previous treatments. The goal is to determine if this combination is safe and effective in slowing cancer growth. Suitable participants have melanoma that cannot be surgically removed and have already tried other cancer treatments without success. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering a chance to be among the first to receive this new combination therapy.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, researchers found that using ceritinib and trametinib together did not cause any unexpected side effects. This means the side effects aligned with what doctors anticipated based on past use of these drugs. Studies have shown that patients generally tolerated this combination well, and doctors identified a manageable dose. No new safety issues emerged, which is a positive sign. Overall, the combination appears safe based on the available information.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Trametinib and Ceritinib for treating melanoma because it offers a unique approach by targeting multiple pathways involved in cancer growth. Unlike standard treatments like immunotherapy or chemotherapy, Trametinib works by inhibiting MEK, a protein that contributes to cell division, while Ceritinib targets ALK and ROS1, which are involved in cancer cell survival and proliferation. By combining these two drugs, the treatment has the potential to more effectively halt the progression of melanoma, especially in cases where other treatments might not be as effective. This dual-target strategy could improve patient outcomes by addressing resistance mechanisms that often limit the success of current therapies.
What evidence suggests that this treatment might be an effective treatment for melanoma?
Research suggests that combining trametinib and ceritinib might be promising for treating melanoma, a type of skin cancer. In this trial, participants will receive both trametinib and ceritinib. Studies have shown that ceritinib can enhance the effectiveness of trametinib in certain melanoma cells. This combination has demonstrated potential benefits for patients who have already tried anti-PD-1 therapies, with some evidence indicating longer survival times. Observations indicate that using ceritinib with trametinib is more effective than using either drug alone. While more research is needed, early findings support the potential benefit of this combination for melanoma patients who have not responded to other treatments.12678
Who Is on the Research Team?
Zeynep Eroglu, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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