RecruitingPHASE3INTERVENTIONAL

A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

This important study is investigating a new approach to treating a type of head and neck cancer called squamous cell carcinoma, which has returned or spread to other parts of the body. The research aims to see if adding a new drug, amivantamab, to existing standard treatments like pembrolizumab, carboplatin, and 5-fluorouracil, can be more effective than the standard treatments by themselves. Participants in this study will be those who haven't had previous treatment for their cancer that has returned or spread. The goal is to find better ways to fight this cancer and improve outcomes for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

500

Start

03 Dec 2025

Estimated completion

18 Jun 2029

Squamous Cell Carcinoma of Head and Neck

What is this study about?

This study is looking for better ways to treat a specific type of cancer called head and neck squamous cell carcinoma, or HNSCC. This cancer starts in the moist, outer lining of your mouth or throat, for example. We're focusing on cases where the cancer has come back or spread beyond its original area, and where standard local treatments are no longer an option.

The main idea behind this research is to see if adding a new medicine, called amivantamab, to the usual treatments can make a difference. Currently, doctors use a combination of drugs like pembrolizumab, carboplatin, and 5-fluorouracil for this type of cancer. This study will compare how well patients do when they receive the new drug combined with these standard medicines, versus those who only receive the standard medicines.

We know that facing a cancer diagnosis where the disease has returned or spread can be very challenging. This study is designed to explore potentially more effective treatment options for people in this situation who haven't had prior systemic treatment for their recurrent or metastatic cancer. By carefully comparing these different treatment approaches, we hope to learn more and ultimately improve care for people with head and neck cancer.

Key takeaways

This study is for head and neck cancer that has returned or spread.
It's comparing standard treatment alone with standard treatment plus a new drug, amivantamab.
Participants must not have had previous drug treatment for their recurrent/metastatic cancer.
Close monitoring by a medical team is part of taking part.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have head and neck squamous cell carcinoma that has come back or spread, and your doctors believe it can't be cured with local treatments like surgery or radiation alone. This includes cancers in your mouth, the middle part of your throat (oropharynx), the lower part of your throat (hypopharynx), or your voice box (larynx).

It's important that you haven't received any previous drug treatment for your cancer once it returned or spread. Your general health and ability to carry out daily activities will be assessed, usually by a simple rating called an ECOG score (0 or 1). Doctors will also need to be able to measure your cancer to see if the treatment is working, and if your oropharyngeal cancer is linked to HPV, your HPV status must be negative.

There are also some reasons why you wouldn't be able to join. For instance, if you have other serious uncontrolled illnesses, certain heart conditions, untreated cancer that has spread to your brain, or if your organs like your kidneys or liver aren't working well enough. You also can't participate if you're known to be allergic or very sensitive to any of the medicines used in the 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.

Are you 18 years old or older?
Do you have head and neck squamous cell carcinoma that has come back or spread?
Have you not received any prior drug treatment for your cancer that has returned or spread?
Are you in reasonably good general health, as assessed by a doctor?
Do you not have certain other serious health conditions, especially heart or brain issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups. One group will receive the new drug amivantamab along with standard treatments, and the other group will receive only the standard treatments. Your medical team will explain which specific medications you will be taking.

Participation will involve regular visits to the clinic for treatments, check-ups, and tests. These tests might include blood tests, scans (like CT scans), and physical exams to monitor your health and how your cancer is responding to treatment. The exact number of visits and tests will depend on the treatment you receive and how you respond. The study will continue as long as the treatment is benefiting you, or until you experience side effects that make continuing difficult, or you choose to withdraw. Afterstopping treatment, there will be follow-up visits or calls to check on your long-term health, which can last for several months or longer.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the new treatment combination is more effective than standard care; however, there's no guarantee it will help your specific condition. You will also be closely monitored by a dedicated medical team. As with all medications, there's a risk of side effects, which can vary from mild to severe, and we can’t predict exactly what side effects any individual might experience. You will be fully informed about known and potential risks of all treatments involved. Remember, joining a study is always your choice, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (177)

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

Ironwood Cancer and Research Center
Verified postcode
Chandler, United States· Recruiting
Providence St Jude Medical Center
Verified postcode
Fullerton, United States· Recruiting
Valkyrie Clinical Trials
Verified postcode
Los Angeles, United States· Recruiting
Valkyrie Clinical Trials Murrieta
Verified postcode
Murrieta, United States· Recruiting
Stanford University Medical Center
Verified postcode
Stanford, United States· Recruiting
Hartford Hospital
Verified postcode
Hartford, United States· Recruiting
Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
Florida Cancer Specialists South
Verified postcode
Fort Myers, United States· Recruiting
University of Miami Sylvester Comprehensive Cancer Center
Verified postcode
Miami, United States· Recruiting
Florida Cancer Specialists North Region
Verified postcode
St. Petersburg, United States· Recruiting
Florida Cancer Specialists East
Verified postcode
West Palm Beach, United States· Recruiting
Emory University
Verified postcode
Atlanta, United States· Recruiting

Common questions

What is `recurrent/metastatic` cancer?

This means your cancer has either come back after previous treatment, or it has spread from where it started to other parts of your body.

What does `standard of care` mean?

This refers to the treatments that are currently accepted by medical experts as appropriate and effective for your type of cancer.

Will I definitely receive the new drug?

No, this study involves two groups. You will either receive the new drug plus standard care, or just the standard care. This allows researchers to compare the treatments fairly.

Do I have to pay to be in the study?

Generally, all study-related treatments and tests are provided at no cost to you. Your study team will give you all the details.

How long will I be in the study?

The time you spend in the study can vary. You'll receive treatment as long as it's helping and you're tolerating it well. After treatment, there will be follow-up appointments to check on your health.

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.