AuthorisedTherapeutic exploratory (Phase II)Interventional

Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers with stable disease (ICONIC)

The ICONIC study is investigating a new approach for treating certain advanced cancers, including melanoma, bladder cancer, lung cancer, and head and neck cancer. This study combines specific immunotherapy drugs (like pembrolizumab, atezolizumab, nivolumab, or cemiplimab, which help your body's immune system fight cancer) with carbon ion radiotherapy (a highly targeted form of radiation that uses carbon particles to destroy cancer cells). Researchers want to see how well this combination works by measuring if tumours shrink, how long people live without their disease getting worse, and the overall survival. The study will also carefully track any side effects. It's a Phase II study, meaning it's exploring whether this new combination is effective and safe enough to be studied further.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Centro Nazionale Di Adroterapia Oncologica

Enrolment target

Start

26 Nov 2024

Unresectable or metastatic melanoma Locally advanced or metastatic urothelial carcinoma Locally advanced or metastatic non-small cell lung cancer (NSCLC)Untreated recurrent/metastatic head & neck sqamous cell carcinoma (HNSCC)

What is this study about?

The ICONIC study (which stands for Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers) is looking at new ways to treat several types of advanced cancer. These include melanoma (a type of skin cancer), bladder cancer, a common type of lung cancer (non-small cell lung cancer), and head and neck cancer. These are cancers that haven't responded well to standard treatments or have spread to other parts of the body.

In this study, doctors are combining two powerful types of treatment: immunotherapy drugs and carbon ion radiotherapy. Immunotherapy drugs, such as pembrolizumab, atezolizumab, nivolumab, and cemiplimab, work by 'unblocking' your immune system, allowing your body's natural defences to recognise and fight cancer cells. Carbon ion radiotherapy is a very precise form of radiation that uses carbon particles to target and destroy cancer cells while trying to spare healthy tissues as much as possible.

The main goal of the study is to see if giving these immunotherapy drugs alongside carbon ion radiotherapy can make tumours shrink or disappear. Researchers will also be checking to see how long people live without their cancer getting worse and how long they live overall. They'll also be carefully monitoring for any side effects or unwanted reactions to these treatments. This is a Phase II study, which means it's an important step in determining if this new combination treatment is promising enough to be tested in larger studies in the future.

Key takeaways

The ICONIC study explores combining immunotherapy with carbon ion radiotherapy for advanced cancers.
It targets specific cancers: melanoma, bladder, lung, and head & neck.
The main goal is to see if tumours shrink and how long patients live.
It's a Phase II study, meaning it's exploring effectiveness and safety.
Participants will receive study medications and a special type of radiation.

Who may be eligible?

To join the ICONIC study, you'll need to meet certain requirements. The study is open to adults aged 18 and over, of any gender. People of all sexes can take part.

More specifically, the study is looking for patients who have been diagnosed with certain types of advanced cancer. These include melanoma that cannot be surgically removed or has spread, bladder cancer that is advanced or has spread, a specific type of lung cancer (non-small cell lung cancer) that is advanced or has spread, or head and neck cancer that has come back or spread and hasn't been treated before.

Beyond these main conditions, doctors will check other aspects of your health and medical history to make sure the study is a safe and suitable option for you. This often involves looking at your general health, how well your organs are working (like your kidneys and liver), and any other medications you might be taking.

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 diagnosed with advanced melanoma, bladder cancer, non-small cell lung cancer, or head and neck cancer?
Has your cancer not responded well to previous treatments, or has it spread?
Are you able to travel to the study site for regular appointments?
Do you understand that this is a research study and not guaranteed treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the ICONIC study, you would receive specific cancer medications (either pembrolizumab, atezolizumab, nivolumab, or cemiplimab) along with treatment using carbon ion radiotherapy. The exact schedule and number of visits would depend on which specific treatment combination you receive and how your body responds. You would have regular appointments for check-ups, blood tests, and scans to monitor your health, how the treatment is working, and to look for any side effects. These assessments would include detailed scans to see if your tumour is shrinking, starting at least 8 weeks after the carbon ion radiotherapy. There would also be ongoing follow-up visits after your main treatment period to track your progress long-term. The total duration of your participation would involve the treatment period and follow-up, which can last for several months or even longer, depending on the study's design and your individual response.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving new and advanced cancer treatments that may help shrink your tumours or slow the progression of your disease. However, like all medical treatments, there are potential risks and side effects from the immunotherapy drugs and carbon ion radiotherapy, which your care team will explain in detail. You will be closely monitored for these. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical 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
Italy

Common questions

What kind of cancers are being studied?

The study is looking at advanced melanoma, bladder cancer, non-small cell lung cancer, and head and neck cancer that haven't responded well to other treatments or have spread.

What are 'immune checkpoint inhibitors'?

These are special medicines that help your body's own immune system find and fight cancer cells more effectively.

What is 'carbon ion radiotherapy'?

It's a very precise type of radiation treatment that uses carbon particles to target and destroy cancer cells while trying to protect healthy tissues.

Will I definitely get benefit from this study?

We cannot guarantee any specific outcome. This is a research study to see if this new treatment combination is effective and safe. Some people may benefit, while others may not.

What phase is this study in?

This is a Phase II study, which means it's an earlier stage of research designed to see if the treatment is effective and identify any side effects.