Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC

This research is investigating a new combination treatment for people with advanced skin cancer (melanoma) or a type of lung cancer (non-small cell lung cancer), especially when their previous immunotherapy treatments have stopped being effective. The study is testing two drugs together: bexmarilimab and nivolumab. Researchers believe bexmarilimab might 'wake up' immune cells in the tumour, helping them send stronger signals to fight the cancer. This could make nivolumab, which is a common immunotherapy drug, work better again. The study has two main parts. First, it will find the safest and most effective dose of bexmarilimab to use with nivolumab. Then, it will test this combination in larger groups of patients with either melanoma or non-small cell lung cancer.

At a glance

Status

Not yet recruiting

Phase

PHASE1, PHASE2

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

01 Jul 2026

Estimated completion

31 Jan 2030

Melanoma (Skin Cancer)Non Small Cell Lung Cancer Solid Tumor in Advanced Stage

What is this study about?

This study is a clinical trial exploring a new approach to treating advanced cancers, specifically melanoma (a type of skin cancer) and non-small cell lung cancer. It's designed for people whose cancers have become resistant to standard immunotherapy, meaning those treatments are no longer working as well as they did.

The trial is focusing on a combination of two drugs: bexmarilimab and nivolumab. Nivolumab is already a known immunotherapy drug that helps the body's immune system fight cancer. The researchers believe that bexmarilimab might play a special role by changing certain immune cells within the tumour. These changes could make the immune cells send out a stronger 'alarm signal,' which might then help other immune cells recognize and destroy the cancer cells more effectively. The hope is that this 're-activation' could allow immunotherapy drugs like nivolumab to work well again against the cancer.

This trial has two main stages, called Phase 1 and Phase 2. In Phase 1, a small group of patients with advanced solid tumours will receive increasing doses of bexmarilimab alongside a standard dose of nivolumab. The main goal here is to find the safest and most suitable dose of bexmarilimab to use in future studies. Once this ideal dose is found, the study moves to Phase 2. In Phase 2, two separate groups of patients – one with non-small cell lung cancer and another with melanoma – will be treated with this selected dose combination, to further understand how well it works and if it can help improve their condition.

Key takeaways

This study is for advanced skin (melanoma) and lung (non-small cell lung) cancers.
It aims to find new ways to help when previous immunotherapy has stopped working.
The trial combines two drugs, bexmarilimab and nivolumab.
It will first confirm the safest dose, then test its effectiveness.
Patients must have had some benefit from prior immunotherapy but now have progressing disease.
You can stop participating at any time.

Who may be eligible?

To join this study, you would typically need to be an adult (18 years or older) with advanced cancer. For those with a solid tumour, it generally means your cancer hasn't responded to usual treatments, or there aren't standard treatments available. You must also be generally well enough to take part, meaning you can mostly look after yourself.

If you have non-small cell lung cancer or melanoma, you must have tried at least one, but no more than three, different treatments for advanced cancer. Crucially, your cancer must have stopped responding to a type of treatment called an immune checkpoint inhibitor (a common immunotherapy), and this progression must have happened within 12 weeks of your last dose. You also need to have shown some benefit from your previous immunotherapy, like getting treatment for more than 6 months or seeing some improvement.

For women who could become pregnant, you would need to confirm you are not pregnant or breastfeeding, and agree to use effective contraception during the study and for six months afterwards. Everyone joining the study needs to have cancer that can be measured by scans.

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?
Do you have advanced melanoma or non-small cell lung cancer?
Has your cancer stopped responding to immunotherapy you previously received?
Did you show some benefit from that past immunotherapy (e.g., treated for 6+ months or showed some improvement)?
Are you generally well enough to manage your daily activities?
If you could become pregnant, are you able to use reliable 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 receive the study drugs, bexmarilimab and nivolumab, given through a drip (intravenously) at specific times. You would have regular appointments for check-ups, which would include blood tests, physical examinations, and scans to monitor your cancer and how you are responding to the treatment. These assessments will help the doctors understand if the treatment is working and if there are any side effects. The total duration of your participation in the study would depend on how your body responds to the treatment and the phase of the study you are in. You would also have follow-up visits after stopping treatment. The exact schedule would be explained in detail by the study team.

Potential risks and benefits

Like all medical treatments, taking part in this study comes with potential benefits and risks. While there's no guarantee, a potential benefit is that the experimental drug combination might help to control your cancer when other treatments haven't. However, there is also a chance you might not benefit. Potential risks include experiencing side effects from the drugs. The research team will carefully monitor you for any side effects and manage them as best as possible. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom
The Royal Marsden NHS Foundation Trust - Drug Development Unit
Verified postcode
Sutton, United Kingdom

Common questions

What is a 'solid tumour'?

A solid tumour is an abnormal mass of tissue that usually doesn't contain cysts or liquid areas. Most cancers, like those of the lung, breast, or bowel, form solid tumours.

What is an 'immune checkpoint inhibitor'?

This is a type of medicine that helps your own immune system recognize and fight cancer cells. Nivolumab is an example of this kind of drug.

What does 'advanced stage' mean?

This usually means the cancer has spread from where it started to other parts of the body, or it can't be cured with surgery alone.

Will I know if I'm getting the active drugs or a dummy treatment?

No, in this study, everyone receives both bexmarilimab and nivolumab. There isn't a dummy treatment (placebo) arm in this trial.

How long will I be on the trial treatment?

You will remain on the treatment as long as it is benefiting you and you are not experiencing significant side effects. The study team will discuss exact timescales with you.

How to find out more

Aasia Hussain, PhD

blaze@icr.ac.uk 02034376301 Official trial record

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