A phase II, monocentric, single arm trial evaluating the efficacy and safety of Pembrolizumab in combination with Lenvatinib in metastatic Uveal MElanoma patients
Uveal melanoma is a rare type of cancer that starts in the eye. When it spreads to other organs, such as the liver, it can be very difficult to treat with standard therapies. This phase II clinical trial is testing a combination of two anti-cancer medicines: pembrolizumab and lenvatinib. Pembrolizumab works by helping your body's immune system recognise and attack cancer cells. Lenvatinib is a targeted medicine that blocks proteins cancer cells need to grow and build new blood vessels. In this trial, all participants receive both medicines together. The main aim of the research is to find out how well this combination shrinks or slows down the cancer, and to carefully check what side effects it might cause. The study is open to adults aged 18 and older whose eye melanoma has spread.
At a glance
What is this study about?
Uveal melanoma is an uncommon cancer that begins in the tissues of the eye. While early treatments can often manage the cancer in the eye itself, the disease can sometimes spread (metastasise) to other parts of the body, most commonly the liver. Once it has spread, standard cancer treatments often do not work as well as doctors would like, meaning new treatment options are urgently needed.
This clinical trial is exploring whether two modern cancer drugs working together can offer better results. The first drug, pembrolizumab, is a type of immunotherapy. It helps take the brakes off your natural immune defences so they can fight cancer cells. The second drug, lenvatinib, is a targeted therapy that starves tumours of the blood supply they need to survive and spread.
Because this is a phase II study, researchers want to see if the two medicines together are safe and effective at shrinking or controlling the tumours. Doctors will closely track how patients respond and monitor any side effects. The results could help shape future treatments for people facing this challenging condition.
Key takeaways
- Tests a two-drug combination (pembrolizumab and lenvatinib) for eye melanoma that has spread.
- A phase II study checking both the safety and effectiveness of the treatment.
- Open to adults aged 18 and older with metastatic uveal melanoma.
- All participants receive the study medications; there is no placebo.
- Participation is entirely voluntary and you can stop at any point.
Who may be eligible?
This study is designed for adults aged 18 or older who have been diagnosed with uveal melanoma that has spread beyond the eye to other parts of the body (metastatic disease).
To take part, participants generally need to be well enough to carry out daily activities and have acceptable blood test results showing that their liver, kidneys, and bone marrow are functioning safely.
People may not be able to join if they have certain other severe medical conditions, active autoimmune diseases, or if they have previously had specific treatments that make taking these study drugs unsafe. Your cancer specialist will review your full medical history to see if this trial is right for you.
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.
- I am aged 18 or over.
- I have been diagnosed with uveal melanoma (melanoma that started in the eye).
- My cancer has spread to other parts of my body (metastatic disease).
- I am well enough to attend regular hospital appointments and take daily medication.
- I am willing to undergo regular scans and blood tests.
What does participation involve?
If you decide to join this study, you will receive pembrolizumab as a drip into a vein (an intravenous infusion) at the hospital, usually once every few weeks. You will also take lenvatinib as a daily capsule at home. You will need to visit the hospital clinic regularly for routine health checks, blood tests, and scans (such as CT or MRI scans) to see how your body and the cancer are responding. You will continue the treatment for as long as it is helping and the side effects are manageable. Even after you stop the medication, the study team will keep in touch to check on your long-term health and wellbeing.
Potential risks and benefits
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Common questions
What is uveal melanoma?
It is a rare type of melanoma that develops inside the eye rather than on the skin. It can sometimes spread to other organs, especially the liver.
Will I receive a dummy drug (placebo)?
No. This is a single-arm study, meaning every person who joins receives the active study treatment.
How are the medicines given?
Pembrolizumab is given as an infusion into a vein at the clinic every few weeks, while lenvatinib is taken as a capsule by mouth every day at home.
How long will I be in the trial?
You will stay on the treatment for as long as your cancer remains controlled and any side effects are manageable, followed by regular check-up visits.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary. You can leave the study at any time, for any reason, without it affecting your ongoing cancer care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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