RecruitingPHASE3INTERVENTIONAL

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

This study is investigating a new treatment device, JNJ-90301900 (NBTXR3), when used alongside standard radiation therapy. Sometimes, another drug called cetuximab might also be given. The aim is to see how well this new combination works and if it's safe for older patients (aged 60 and above) with locally advanced squamous cell carcinoma of the head and neck. These are patients who haven't had previous treatment for this specific cancer and cannot receive certain types of chemotherapy due to other health factors. The study compares the new treatment combination to just receiving radiation therapy (with or without cetuximab) to see which approach is better.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Enrolment target

500

Start

10 Dec 2021

Estimated completion

30 Jun 2028

Carcinoma, Squamous Cell

What is this study about?

This study is for people in the UK and globally who have a type of cancer in the head and neck area called locally advanced squamous cell carcinoma. This means the cancer has grown in the local area but hasn't spread far. Doctors are looking for better ways to treat this condition, especially for older patients who might not be able to have standard chemotherapy treatments.

The study is testing a new approach that uses a substance called JNJ-90301900 (NBTXR3). This substance is injected directly into the tumour. The idea is that when this substance is activated by regular radiotherapy (which uses high-energy rays to kill cancer cells), it might make the radiotherapy more effective at shrinking or destroying the tumour. In some cases, another medicine called cetuximab might also be given alongside these treatments.

Patients taking part will be randomly assigned to one of two groups. One group will receive the new substance (JNJ-90301900 (NBTXR3)) plus standard radiation therapy (with or without cetuximab). The other group will receive only the standard radiation therapy (with or without cetuximab). This comparison helps the researchers understand if adding the new substance improves the treatment outcomes and is safe. This is a "Phase 3" study, which means it's one of the final steps before a new treatment might be considered for wider use.

Key takeaways

It's for specific types of locally advanced head and neck cancer.
It's for patients aged 60 and over who can't have platinum chemotherapy.
It tests a new substance (NBTXR3) with radiation, sometimes adding cetuximab.
You'll be randomly assigned to either the new treatment combination or standard radiation.
The aim is to see if the new approach is more effective and safe.

Who may be eligible?

To be considered for this study, you must be at least 60 years old and have a confirmed diagnosis of squamous cell carcinoma in specific areas of the head and neck, such as the mouth, throat, or voice box. Your cancer needs to be at a certain advanced stage locally, and there must be one main tumour that doctors can inject directly.

An important part of the study is for patients who cannot have platinum-based chemotherapy. This might be due to kidney problems, significant hearing loss or ringing in the ears, numbness or tingling in your hands and feet, heart conditions, or being aged 75 or older (or between 70-74 with a low Geriatric 8 score indicating frailty).

There are also reasons why you might not be able to join. For example, if your cancer is in different parts of the head and neck (like the nose or salivary glands), if it's a different type of cancer, or if you've already had surgery, radiotherapy, or chemotherapy for this head and neck cancer. You also can't have other active cancers or ongoing serious infections.

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 60 years old or older?
Do you have confirmed squamous cell carcinoma of the head and neck?
Are you unable to receive platinum-based chemotherapy due to health reasons (e.g., kidney issues, hearing loss, heart problems)?
Have you not had previous treatment for this specific head and neck cancer?
Do you have one main tumour that could be injected directly?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups. One group will receive the new treatment (JNJ-90301900 (NBTXR3) injected into your tumour before radiation therapy, possibly with cetuximab), and the other group will receive standard radiation therapy (possibly with cetuximab).

You will have regular appointments with the study team to monitor your health, how the treatment is working, and any side effects you might experience. These visits will likely involve physical exams, blood tests, and scans. The exact number and frequency of visits will be explained by the study team. You will be monitored throughout your treatment and possibly for a period afterwards to track your progress. The total duration of your participation, including follow-up, will be made clear by the study team.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to new treatments before they are widely available and close monitoring by medical professionals. However, there are also potential risks, including side effects from the treatments, which might be new or more severe than those from standard care. The new treatment being tested might not work for everyone, or it might not work as well as expected. Your doctors and the study team will explain all known side effects and potential risks thoroughly. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (191)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
City of Hope
Verified postcode
Duarte, United States· Recruiting
University of California at San Diego Moores Cancer Center
Verified postcode
La Jolla, United States· Recruiting
Memorial Radiation Oncology Medical Group Laguna Hills
Verified postcode
Laguna Hills, United States· Completed
UCLA Hematology Oncology
Verified postcode
Los Angeles, United States· Recruiting
Hoag Memorial Hospital
Verified postcode
Newport Beach, United States· Completed
University of California San Francisco
Verified postcode
San Francisco, United States· Recruiting
George Washington University Cancer Center
Verified postcode
Washington D.C., United States· Recruiting
Mayo Clinic Jacksonville
Verified postcode
Jacksonville, United States· Recruiting
AdventHealth Orlando
Verified postcode
Orlando, United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
Emory University Hospital Midtown
Verified postcode
Atlanta, United States· Recruiting

Common questions

What is JNJ-90301900 (NBTXR3)?

It's a new substance injected into the tumour that is designed to help radiation therapy work better by increasing its effect on cancer cells.

What is cetuximab?

Cetuximab is a type of targeted therapy drug that can be used alongside radiation therapy for some head and neck cancers, aiming to help shrink the tumour.

Why is this study only for older patients?

This study focuses on older patients (aged 60 and above) who often cannot tolerate certain standard chemotherapy treatments due to other health conditions or side effects, making new treatment options particularly important for them.

Will I know which treatment group I'm in?

This is an 'open-label' study, which means both you and the study team will usually know which treatment you are receiving.

Where does 'platinum-ineligible' come from?

This means you cannot receive chemotherapy drugs that contain platinum (like cisplatin) for various medical reasons, such as kidney problems, severe hearing issues, or certain heart conditions.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

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