AuthorisedTherapeutic exploratory (Phase II)Interventional

Pilot study with Low-dose nivolumab in Advanced Neoplasms that are TMB-high

This clinical trial is looking at a medicine called nivolumab (also known as Opdivo) for adults with advanced cancer. It focuses specifically on tumours described as 'TMB-high'. TMB stands for tumour mutational burden, meaning the cancer cells have a high number of genetic changes. These changes can make tumours easier for the immune system to recognise. Nivolumab is an immunotherapy drug that helps your body's immune system fight cancer. In this study, doctors are testing a lower dose of the drug than is usually given. They want to find out how many patients see their tumours shrink or disappear, and whether this lower dose is safe and effective. Taking part involves receiving the drug through a drip in hospital, having regular health checks and scans, and working closely with your cancer care team.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

UZ Brussel

Enrolment target

Start

09 Sep 2026

TMB-high advanced neoplasms

What is this study about?

When cancer develops, changes happen inside the DNA of the cancer cells. Some tumours have a particularly high number of these genetic mistakes. Doctors describe these as 'TMB-high' tumours (high tumour mutational burden). Because these cells look very unusual, the body's immune system often has a better chance of spotting and attacking them, especially with the help of modern immunotherapy medicines.

Nivolumab is a well-known immunotherapy drug that works by releasing the 'brakes' on the immune system, allowing natural defence cells to attack the cancer. While nivolumab is already approved for several cancers at standard doses, researchers are keen to find out whether a lower dose could work just as well for TMB-high cancers.

Using a lower dose could potentially reduce the chance of troublesome side effects and make treatment gentler for patients. In this trial, doctors will carefully track how tumours respond and measure the overall success rate of the treatment.

Key takeaways

This study tests a lower dose of the immunotherapy drug nivolumab for advanced cancers.
It is specifically for tumours identified as 'TMB-high' (high tumour mutational burden).
The main aim is to see how well the lower dose shrinks or stabilises tumours.
Participation involves hospital visits for drip infusions, regular blood tests, and scans.
Joining is entirely your choice, and you can withdraw at any time.

Who may be eligible?

This trial is open to adults aged 18 and older who have been diagnosed with an advanced cancer or tumour. To take part, laboratory tests on a sample of your tumour must show that it is 'TMB-high', meaning it has a large number of genetic mutations.

You will need to be well enough to carry out daily activities and attend hospital visits. Because this is an early-stage study for advanced disease, participants have usually already tried standard cancer treatments, or there may be no standard therapies suitable for their type of cancer.

People with certain medical conditions, such as severe active autoimmune diseases or serious ongoing infections, may not be able to join. Your hospital doctor will review your complete medical history and blood tests to confirm whether taking part is safe 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 older.
I have been diagnosed with an advanced cancer or tumour.
My tumour has been tested and confirmed as 'TMB-high'.
I am well enough to attend regular hospital appointments.
I do not have an uncontrolled autoimmune disease or severe active infection.

Answer every question to see your result.

What does participation involve?

If you join the trial, you will receive nivolumab as an intravenous infusion (a slow drip into a vein) at a hospital clinic. Before treatment starts, you will have baseline tests, including blood tests, physical checks, and imaging scans (such as CT or MRI scans) to measure your cancer.

You will visit the clinic regularly to receive your doses and see the medical team. During these appointments, the team will check for any side effects and take blood samples. Every few months, you will have repeat scans to see how your tumour is responding to the medicine.

Treatment usually continues for as long as it helps you and remains safe, though the exact length varies. After you finish the trial treatment, the study team will continue to follow your health through periodic clinic visits or phone calls.

Potential risks and benefits

The possible benefit of taking part is that the lower dose of nivolumab may help shrink or control your cancer, although this cannot be guaranteed. However, all cancer medicines carry risks. Nivolumab can cause the immune system to attack normal tissues, leading to side effects such as tiredness, skin rashes, diarrhoea, or changes in how organs like the liver or thyroid work. Using a lower dose aims to keep these effects milder, but they can still occur. Taking part is completely voluntary, and you are free to leave the trial at any time without it affecting your standard NHS care.

Locations (1)

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

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Unverified
Belgium

Common questions

What does TMB-high mean?

TMB stands for tumour mutational burden. A 'high' TMB means your cancer cells have many genetic changes, which can make them easier for immunotherapy drugs to target.

Why test a lower dose of nivolumab?

Doctors want to see if a smaller amount of the medicine works just as well to control the cancer while potentially causing fewer or milder side effects.

How is the medicine given?

Nivolumab is given as a liquid through a drip directly into a vein, usually at a hospital day unit.

Will I have to pay for the trial treatment?

No, clinical trial medicines and study-specific tests are provided free of charge, and you will continue to receive care through your healthcare team.

Can I stop taking part if I change my mind?

Yes. You have the right to withdraw from the trial at any point, for any reason, and your regular medical team will discuss alternative treatment options with you.