Active not recruitingPHASE2INTERVENTIONAL

Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

If you have advanced melanoma that has spread or can't be removed by surgery, and your previous treatments haven't worked, this study might be for you. Researchers are testing new treatment combinations to see if they can help. The study will look at how effective these new medicines (LXH254, LTT462) are when given with established treatments like Trametinib or Ribociclib. All participants will have already received other melanoma therapies, including checkpoint inhibitors. The main aim is to find out if these new drug combinations can improve how well people respond to treatment and to check if they are safe. This is a Phase 2 study, meaning it's exploring if the treatments work and can be used in larger studies later on.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

134

Start

30 Oct 2020

Estimated completion

02 Feb 2027

Melanoma

What is this study about?

This study is focused on a type of skin cancer called melanoma, specifically when it's advanced. This means the cancer has spread to other parts of the body (metastatic) or can't be removed by surgery (unresectable). The good news is that medical science is always looking for better ways to treat cancer, and that's exactly what this study is trying to do for people facing advanced melanoma.

The main idea behind this research is to test combinations of new medications called LXH254 and LTT462. These new drugs will be given alongside treatments that are already known, like Trametinib or Ribociclib. The hope is that by combining these medicines, they might be more effective at fighting the cancer than previous treatments. All the patients taking part in this study will have already received other treatments for their melanoma, and the cancer will have continued to grow despite these therapies.

By carefully observing how patients respond to these new combinations and monitoring for any side effects, the researchers want to understand if these treatments work well and are safe. This kind of research is crucial because it helps doctors find better options for people with difficult-to-treat cancers, potentially leading to new standard treatments in the future. It's a key step in medical progress against melanoma.

Key takeaways

This study evaluates new drug combinations for advanced melanoma.
It's for people whose melanoma has progressed after previous treatments.
The study aims to check how well the drugs work and their safety.
Potential for new treatment options for difficult-to-treat melanoma.
Your medical team will closely monitor your health throughout.

Who may be eligible?

To join this study, you must be at least 12 years old. If you're aged between 12 and 17, you need to weigh more than 40 kilograms (about 6 stone 4 pounds). All participants must have melanoma that has been confirmed by a doctor to be advanced – meaning it cannot be removed with surgery or has spread to other parts of the body.

Another important requirement is that you must have already received treatment for your advanced melanoma in the past, and your melanoma must have continued to grow despite these treatments. The exact types of previous treatments vary slightly depending on the specific features of your tumour, but generally, you will have had checkpoint inhibitor therapies. If your melanoma has a specific change called a 'BRAF V600 mutation', you'll also need to have received targeted therapy for it.

There are also certain conditions that would prevent someone from joining the study, which the medical team will discuss with you. These are to ensure your safety and that the study can provide clear results. Your doctor will be able to tell you if you meet all the criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 12 years old or older? (If 12-17, do you weigh over 40kg?)
Have you been diagnosed with advanced melanoma that has spread or can't be removed?
Has your melanoma been previously treated, but it has started to grow again?
Have you received checkpoint inhibitor therapy for your melanoma?
If your melanoma has a specific BRAF V600 mutation, have you also received targeted therapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be giving new medication combinations for your melanoma. The doctors and nurses in the study team will closely monitor your health. This will involve regular visits to the hospital or clinic, where you might have blood tests, scans (like CT or MRI scans) to check your cancer, and physical examinations. You'll also be asked questions about how you're feeling and any side effects you might be experiencing. The exact schedule of visits and assessments will be explained to you in detail by the study team. You'll continue to receive the study medication for as long as it is benefiting you and you are tolerating it well. Following this, there will be a follow-up period to monitor your health. The total time you're involved in the study can vary, but the study team will give you a clear idea of what to expect.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments for your melanoma before they are widely available. While these treatments are being tested to see if they are effective, there's no guarantee that they will work for everyone, and some people may not experience any improvement. As with all medications, there's a risk of side effects, which could range from mild to serious. The study team will provide you with a full list of known and potential side effects. Your safety is a top priority, and you'll be closely monitored throughout the study. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (36)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Angeles Clinic and Research Institute
Verified postcode
Los Angeles, United States
UCSF Medical Center
Verified postcode
San Francisco, United States
Florida Cancer Specialists
Verified postcode
Fort Myers, United States
H Lee Moffitt Cancer Center and Research Institute
Verified postcode
Tampa, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
Dana Farber Cancer Institute
Verified postcode
Boston, United States
Mayo Clinic Mayo Rochester
Verified postcode
Rochester, United States
Mayo Clinic Rochester
Verified postcode
Rochester, United States
NYU Laura and Isaac Perlmutter Cancer Center
Verified postcode
New York, United States
Memorial Sloan Kettering
Verified postcode
New York, United States
University of Pittsburgh Med Center
Verified postcode
Pittsburgh, United States
Univ of TX MD Anderson Cancer Cntr
Verified postcode
Houston, United States

Common questions

What is advanced melanoma?

Advanced melanoma means the skin cancer has spread to other parts of the body or cannot be removed by surgery.

What are 'checkpoint inhibitors' and 'targeted therapy'?

These are types of medicines that work in different ways to fight cancer. Checkpoint inhibitors help your immune system attack cancer, while targeted therapies focus on specific features of cancer cells.

What does 'Phase 2' in the study mean?

Phase 2 means this study is mainly checking if the new treatments work for patients and if they are safe. It follows earlier studies that checked for safety in small groups.

Will I know if I'm getting the old treatment or the new one?

All participants in this study will receive combinations of the new medicines (LXH254, LTT462) with established ones (Trametinib, Ribociclib). There isn't a placebo group in this study.

What happens if the treatment doesn't work for me?

Your doctors will regularly monitor how your cancer is responding. If the treatment isn't working or if you experience unacceptable side effects, your study doctors will discuss other treatment options with you.