RecruitingNAINTERVENTIONAL

Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors

This study aims to discover if a natural substance, Urolithin A (also known as MitoPure®), can help the immune system of people with newly diagnosed solid cancers like non-small cell lung cancer or melanoma. These patients are already receiving a modern cancer treatment called immune checkpoint inhibitors. Researchers want to see if adding Urolithin A improves how well the immune system responds to these treatments, compared to patients who receive a dummy pill (placebo) instead. The study hopes to understand if Urolithin A can make these important cancer treatments even more effective.

At a glance

Status

Recruiting

Phase

Sponsor

Goethe University

Enrolment target

Start

02 Jan 2026

Estimated completion

01 Mar 2027

Solid Cancer Non-Small Cell Lung Cancer Melanoma

What is this study about?

This research study is looking at new ways to help people with certain types of cancer. If you have been diagnosed with a solid cancer, such as non-small cell lung cancer or melanoma, and are about to start a treatment called immune checkpoint inhibitors, this study might be relevant to you. Immune checkpoint inhibitors are a modern type of cancer treatment that helps your body's own immune system fight cancer cells more effectively.

The study wants to find out if taking a natural substance called Urolithin A, also known as MitoPure®, at the same time as your immune checkpoint inhibitor treatment, can make a difference. Urolithin A is thought to have effects on the immune system, and researchers are keen to see if these effects could be beneficial for cancer patients. They will compare patients who take Urolithin A with those who take a placebo, which is an inactive dummy pill, to see if there are any clear differences.

By taking part, you would be helping doctors learn more about how Urolithin A might work alongside your existing cancer treatment. This could lead to better ways of treating cancer in the future, potentially helping many other people like you. The goal is to see if Urolithin A has any positive impact on the immune system's fight against cancer when combined with this standard modern therapy.

Key takeaways

Tests Urolithin A with standard cancer treatment (immune checkpoint inhibitors).
Aims to improve immune system response in solid cancers.
Compares Urolithin A to a dummy pill (placebo).
For newly diagnosed patients, no prior cancer drug treatment.
Participation involves regular visits and blood samples.
Your standard cancer care continues alongside the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been recently diagnosed with a solid cancer, such as lung cancer or melanoma. This means you haven't had other cancer treatments like chemotherapy for this current cancer yet, though you might be having some treatments before surgery (neoadjuvant therapy).

You must be planning to start a type of cancer treatment called an immune checkpoint inhibitor, either on its own or with chemotherapy. It's important that you're generally well enough to manage the study, with a life expectancy of at least 3 months and able to attend all appointments.

There are also some important reasons why you might not be able to join. For example, if you've recently taken certain medications that affect the immune system or have taken mitochondrial supplements (like coenzyme Q1) recently, you would not be eligible. If you're a woman who could become pregnant, you'd need to use effective contraception during the study. The study team will check all these details carefully with 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.

Are you 18 years old or older?
Have you been recently diagnosed with a solid cancer (like lung cancer or melanoma) and not yet had other drug treatments for it?
Are you about to start an immune checkpoint inhibitor treatment?
Are you generally well enough to attend appointments for at least 3 months?
Have you avoided certain immune-affecting medicines or mitochondrial supplements in the last 3 months?
If female and able to get pregnant, are you willing to use effective contraception during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would either receive Urolithin A (MitoPure®) or a placebo (a dummy pill that looks the same) for a set period. You wouldn't know which one you're taking, and neither would your doctors, which helps ensure the results are fair. Your cancer treatment with immune checkpoint inhibitors would continue as planned, as this is your standard treatment.

Throughout the study, you would have regular hospital visits. During these visits, doctors and nurses would take blood samples (called 'biospecimens') so they can look at how your immune system is responding to the treatment and the study drug. These visits would be scheduled to fit in with your regular cancer care as much as possible. The study team would explain exactly how often you would need to visit and for how long the study would continue for you.

Potential risks and benefits

Participating in research always has potential benefits and risks. A potential benefit of this study is that Urolithin A might help your immune system fight your cancer more effectively, although we don't know this for sure yet. There's also the chance that taking part helps future patients by adding to our understanding of cancer treatments. Potential risks include side effects from the Urolithin A, although it's a natural substance, or from additional blood tests. The dummy pill itself will not have side effects. You will be closely monitored for any reactions. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie
Verified postcode
Frankfurt, Germany· Recruiting

Common questions

What is Urolithin A?

Urolithin A is a natural substance that is made by your body when you eat certain foods, like pomegranates and berries. It's being studied for its potential health benefits, including how it might affect the immune system.

What are immune checkpoint inhibitors?

These are modern cancer treatments that work by helping your body's own immune system recognise and attack cancer cells. They are a standard treatment for many cancers today.

Will I know if I'm getting Urolithin A or the placebo?

No, neither you nor your doctors will know if you are taking Urolithin A or the placebo. This is called 'blinding' and helps to make sure the study results are fair and unbiased.

How long will I need to be in the study?

The study team will give you all the details about the exact duration for your participation and how long you will need to take the study medication. They will also explain how often you will need to attend appointments.

What happens if I change my mind?

You can decide to leave the study at any time, for any reason. This will not affect your relationship with your doctors or the standard medical care you receive.

How to find out more

Fabian Acker, MD

acker@med.uni-frankfurt.de 06963015970 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.