Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma

This research study is for older patients with a type of advanced head and neck cancer that doctors don't think will respond well to platinum-based chemotherapy. The study is investigating a new treatment approach. It involves a special gel called NBTXR3, which is injected into the tumour and then activated by standard radiotherapy. In some cases, another medication called Cetuximab (also known as Erbitux) might also be used alongside the radiotherapy. The main aim of the study is to see if this new combination helps patients live longer without their cancer growing or spreading. Researchers will also look at how long patients live overall. This is an important step to find better ways to treat this specific type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Nanobiotix

Enrolment target

Start

08 Nov 2024

Locally Advanced Head & Neck Squamous Cell Carcinoma

What is this study about?

This study is called a 'Phase 3' study, which means it's a very important stage of research. It's looking at a new treatment for a type of cancer called 'Locally Advanced Head and Neck Squamous Cell Carcinoma'. This cancer affects parts of the head and neck and has grown but hasn't spread to distant parts of the body. Specifically, this study is for older patients who might not be able to have standard chemotherapy treatment, perhaps because of other health conditions.

The new treatment involves a special gel called NBTXR3. This gel is put directly into the tumour. Once it's in place, it's activated by radiotherapy, which is a common cancer treatment using high-energy rays. Sometimes, another drug called Cetuximab (brand name Erbitux) might also be given alongside the radiotherapy. Researchers want to see if this combination therapy can help stop the cancer from growing or coming back, and if it helps people live longer overall.

The main goal is to measure how long patients live without their cancer getting worse, whether it's growing locally, spreading, or causing death. They will also look at how long patients live overall. This is about finding better and gentler ways to treat this challenging cancer, especially for older patients who may be more fragile.

Key takeaways

This study is for advanced head and neck cancer in older patients.
It tests a new gel (NBTXR3) combined with radiotherapy, possibly with another drug (Cetuximab).
The main goal is to see if it helps patients live longer without cancer worsening.
It's an important step to find better, gentler treatments.
Participation involves regular hospital visits for treatment and check-ups.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 or older. There is no upper age limit, meaning patients of all adult ages could potentially join. Both men and women are welcome to take part.

Key to joining is having 'Locally Advanced Head & Neck Squamous Cell Carcinoma', which means the cancer is confined to the head and neck area but has grown significantly. Your doctor would also need to determine that standard platinum-based chemotherapy is not a suitable option for you, perhaps due to your overall health or other reasons.

There will be other detailed medical checks to make sure the study is safe and appropriate for you, and that your health status meets all the requirements. Your doctors will discuss these with you thoroughly.

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 'Locally Advanced Head & Neck Squamous Cell Carcinoma'?
Has your doctor said you're not a good candidate for standard platinum-based chemotherapy?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be carefully monitored throughout. It will involve regular visits to the hospital for assessments, which could include physical examinations, blood tests, and scans to track your health and how the treatment is working. The main treatment involves receiving the NBTXR3 gel (injected into the tumour) and then undergoing radiotherapy. If you are in a group that receives Cetuximab, you would also have that as an infusion.

These treatments and assessments would continue for a period, and then you would have follow-up visits to see how you are doing over the longer term. The total duration of your participation, including follow-up, could be quite extensive, potentially lasting several years. All procedures, schedules, and expectations will be clearly explained by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is the chance to receive a new and innovative treatment that might be more effective or have fewer side effects than standard options, especially considering you might not be suitable for chemotherapy. However, there's no guarantee the treatment will work for you, and it's possible it may not be better than existing care. As with any new treatment, there could be unknown side effects or reactions to the NBTXR3 gel, radiotherapy, or Cetuximab, in addition to the known side effects of each. You will be closely monitored for any problems. It is very important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Czechia
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Unverified
Greece
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Unverified
Germany

Common questions

What is 'Locally Advanced Head & Neck Squamous Cell Carcinoma'?

It's a type of cancer that starts in the flat cells lining the head and neck. 'Locally advanced' means it has grown quite a bit in the area but hasn't spread to distant parts of your body.

What is NBTXR3?

NBTXR3 is a special gel that's injected directly into the tumour. It's designed to work with radiotherapy to make the treatment more effective at killing cancer cells.

What is Cetuximab (Erbitux)?

Cetuximab, also known by its brand name Erbitux, is a type of cancer drug given as an infusion. It works by targeting specific proteins on cancer cells to help stop their growth.

Why is this study for older patients?

This study specifically looks at older patients whose doctors believe standard chemotherapy might not be suitable for them. It aims to find better and potentially gentler treatment options for this group.

Will I definitely get the new treatment?

This is a research study, so you might be in a group that receives the new treatment or a group that receives standard care (like radiotherapy alone or with Cetuximab, without NBTXR3) to compare the results. Your doctors will explain which group you are in.