RecruitingPHASE2INTERVENTIONAL

Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease

This study explores a new way to treat certain advanced cancers, including lung, head and neck, melanoma, and bladder cancers. For patients whose cancer is stable while on immunotherapy (like pembrolizumab), researchers want to see if adding a special type of radiation, called carbon ion therapy, can improve outcomes. Immunotherapy helps your body's immune system fight cancer, and studies suggest that this specific radiation might make immunotherapy work even better. The study will check if this combined approach is safe and effective for patients who have already seen their cancer stabilised by immunotherapy alone.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

CNAO National Center of Oncological Hadrontherapy

Enrolment target

Start

26 Jul 2022

Estimated completion

01 Aug 2026

Non Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Melanoma Urothelial Carcinoma

What is this study about?

This study is looking into a new way to treat certain advanced cancers where standard immunotherapy has managed to keep the cancer stable, meaning it hasn't grown but also hasn't shrunk significantly. Immunotherapy works by boosting your body's own immune system to fight the cancer, and it's a very important treatment for many advanced cancers today.

Researchers wonder if adding a special type of radiation treatment, called carbon ion therapy, could help immunotherapy work even better. Carbon ion therapy is a very precise way to deliver radiation to a tumor. Scientists believe that this type of radiation might not only kill cancer cells directly but also stimulate the immune system in a way that helps immunotherapy become more powerful. This study is trying to understand if combining these two treatments is a good idea, focusing on its safety and how well it works.

The idea is to improve how well immunotherapy works, especially for patients whose cancer has reached a stable point. By being very precise with the radiation, the aim is to damage the cancer cells while protecting healthy immune cells, which are crucial for the body's fight against cancer. This is a Phase 2 study, which means it's still in the earlier stages, gathering information on safety and initial effectiveness.

Key takeaways

This study combines immunotherapy with a special radiation treatment for certain advanced cancers.
It's for patients whose cancer has been stable on existing immunotherapy.
The goal is to see if adding this radiation can make immunotherapy work better and is safe.
Carbon ion therapy is a precise radiation that might boost the immune response.
This is a Phase 2 study focused on safety and early effectiveness.
Treatment with carbon ion therapy happens in Pavia, Italy.

Who may be eligible?

To be considered for this study, you would need to have certain types of cancer, such as non-small cell lung cancer, head and neck cancer, melanoma, or bladder cancer. Importantly, you must already be receiving a specific type of immunotherapy (like pembrolizumab) as part of your standard care, and your cancer needs to have been stable with this treatment. This means your cancer hasn't grown or spread significantly during your immunotherapy.

You also need to have at least two areas of cancer that can be measured, one of which can be treated with carbon ion therapy. You must be aged 18 or over and generally well enough to take part, with a good physical ability to manage your daily life.

However, there are reasons you might not be able to join. For example, if you've had certain other cancer treatments at the same time as immunotherapy, or if you've already had radiation to the specific tumor that would be treated in this study. People with severe autoimmune diseases or a high number of cancer spots (more than 10) are also not suitable for this particular study.

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.

Do you have non-small cell lung, head and neck, melanoma, or bladder cancer?
Are you currently receiving immunotherapy (like pembrolizumab) and has your cancer been stable?
Are you 18 years old or older?
Do you have at least two measurable cancer spots?
Have you NOT had radiation to the spot that would be treated in this study?
Do you feel generally well enough to manage daily activities?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue your current immunotherapy treatment. Additionally, you will receive carbon ion therapy for one of your cancer spots that hasn't been treated with radiation before. This special radiation treatment will be given at Fondazione CNAO in Pavia, Italy. You will have regular check-ups and tests, such as scans (CT or MRI) and blood tests, to see how your body is responding to the treatment and to monitor for any side effects. The exact number of visits and the full duration of your participation will be explained in detail by the study team, so you know what to expect.

Potential risks and benefits

Participating in this study might offer a potential benefit if combining carbon ion therapy with immunotherapy proves more effective than immunotherapy alone for your stable cancer. However, as with any medical treatment, there are potential risks and side effects, both from the immunotherapy you're already receiving and from the added carbon ion therapy. The study team will carefully monitor you for any side effects and explain all potential risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

GSI Helmholtzzentrum für Schwerionenforschung GmbH
Verified postcode
Darmstadt, Germany· Active not recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Verified postcode
Milan, Italy· Recruiting
National Center for Oncological Hadrontherapy (CNAO)
Verified postcode
Pavia, Italy· Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Verified postcode
Pavia, Italy· Recruiting

Common questions

What is 'carbon ion therapy'?

It's a very precise type of radiation treatment that uses carbon particles to target cancer cells, aiming to damage them more effectively while protecting surrounding healthy tissues.

What does 'immunotherapy' do?

Immunotherapy helps your body's own immune system recognise and fight cancer cells.

What does 'stable disease' mean in this study?

It means your cancer hasn't grown or spread significantly while you've been receiving immunotherapy treatment.

Where does the carbon ion therapy take place?

The carbon ion therapy will be given at Fondazione CNAO, which is located in Pavia, Italy.

Can I still join if I've had other cancer treatments?

It depends on the treatment. If you've had certain chemotherapy or other immunotherapy combinations, or previous radiation to the specific spot they want to treat, you might not be able to join. The study team will check this carefully.

How to find out more

Chiara Campo, PhD

campo@cnao.it +39 0382078407 Official trial record

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