RecruitingPhase IIIInterventional

A study of amivantamab in addition to standard of care agents compared with standard of care in participants with recurrent/metastatic head and neck cancer

This study is investigating a new medicine called amivantamab for people with head and neck cancer that has come back or spread, and where current treatments haven't worked well for everyone. Head and neck cancer starts in the mouth or throat. Researchers want to see if adding amivantamab to standard treatments like pembrolizumab and carboplatin can slow tumour growth more effectively and help people live longer, compared to standard treatments alone. Amivantamab works by blocking two specific proteins that help cancer cells grow. The study involves adults who haven't had previous treatment for their advanced head and neck cancer. This Phase III study aims to find out if this new combination could offer a better way to treat this condition.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Janssen-Cilag International NV

Enrolment target

500

Start

23 Oct 2025

Estimated completion

16 Jun 2027

Recurrent/metastatic head and neck squamous cell carcinoma

What is this study about?

This study is looking into new ways to treat a type of cancer called head and neck squamous cell carcinoma (HNSCC). This cancer can start in the mouth or throat. Sometimes, current treatments don't work for everyone, so doctors are always searching for better options to improve how people live and their quality of life. This research is important because it could lead to new treatments for people who need them.

The new medicine being tested is called amivantamab. It's a special kind of protein designed to block two other proteins, EGFR and MET, that help cancer cells grow. By blocking these, amivantamab might slow down or even stop the cancer from growing. In this study, doctors want to see how well amivantamab works when given together with other standard cancer medicines like pembrolizumab and carboplatin. They will compare this new combination against standard treatment options that don't include amivantamab.

The study is for adults who have head and neck cancer that has come back (recurrent) or spread (metastatic) and haven't had treatment for this stage of their cancer before. This is a 'Phase III' study, which means it's a large study that compares the new treatment with existing ones to see if it's more effective and safe. The goal is to find out if adding amivantamab can help people live longer and improve their health outcomes.

Key takeaways

The study is for recurrent/metastatic head and neck cancer.
It tests a new medicine, amivantamab, against standard treatments.
Participants will be randomly assigned to one of two treatment groups.
The treatment involves drips or injections every three weeks and can last up to 24 months.
Strict birth control is required for both men and women during and after the study.
The study aims to improve outcomes and quality of life for patients.

Who may be eligible?

This study is looking for adult patients, aged 18 or older, who have a specific type of head and neck cancer called squamous cell carcinoma. This cancer must have returned or spread, and doctors must consider it incurable with local treatments alone. You also shouldn't have received any previous treatment for your cancer at this advanced stage.

To join, your general health needs to be good, measured by something called an ECOG performance status of 0 or 1. Doctors will also need to be able to measure your tumour to see if the treatment is working. This might involve a biopsy of the tumour or providing an existing tissue sample.

There are also important rules about birth control. If you can become pregnant, you must have a negative pregnancy test and agree to use highly effective contraception during the study and for 3-14 months afterwards. Men in the study whose partners can become pregnant must also use effective contraception unless they've had a vasectomy. You cannot be pregnant or breastfeeding to take part.

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 previous cancer treatment for this stage of your condition?
Are you willing and able to use strict birth control if you or your partner can become pregnant?
Are you in reasonably good general health (ECOG 0 or 1)?
Are you able to provide a tissue sample (biopsy) or have a recent one available?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have a screening period lasting up to 28 days. During this time, doctors will do health checks and tests to make sure the study is right for you. If you're suitable, you'll then be randomly assigned to one of two treatment groups, like flipping a coin, so neither you nor your doctor chooses which group you're in.

Group A will receive a new medicine called amivantamab, along with pembrolizumab and carboplatin. Group B will receive pembrolizumab, 5-fluorouracil, and either carboplatin or cisplatin. These medicines are given through a drip into your vein or as an injection, usually every three weeks. The treatment period could last for up to 24 months (two years). After your treatment has finished, you'll have regular follow-up visits so the doctors can continue to monitor your health and how you're doing. The study is expected to run from September 2025 to June 2029.

Potential risks and benefits

At the time of registration, specific benefits of participating in this study were not listed. However, by taking part in a clinical trial, you are contributing to medical research that could help others in the future, and you will receive close medical monitoring. All treatments carry potential risks and side effects. For this study, you will be given detailed information about the possible side effects of amivantamab, such as skin rashes, lung inflammation (which can be serious), and reactions when the medicine is given. There are also risks with other treatments like chemotherapy (carboplatin, cisplatin, 5-fluorouracil) and pembrolizumab, which will be explained. Procedures like blood tests, ECGs, MRI scans, and CT scans also have minor risks, such as discomfort, allergic reactions to dyes, or very small radiation exposure. 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.

The Royal Marsden Hospital (surrey)
City only
Sutton, England

Common questions

What type of cancer is this study for?

This study is for head and neck squamous cell carcinoma that has come back or spread and hasn't been treated before at this stage.

What is amivantamab?

Amivantamab is a new medicine designed to block two proteins that help cancer cells grow, aiming to slow down or stop the cancer.

Will I get the new drug amivantamab?

You might. Participants are randomly put into one of two groups; one group will receive amivantamab, and the other will receive standard treatments.

How often will I need treatment?

Treatments are generally given through a drip or injection every three weeks, and the treatment period could last up to two years.

Can I get pregnant or make someone pregnant during the study?

No, you must use strict birth control during the study and for several months afterwards due to potential risks to an unborn baby.

How to find out more

Joe Taylor

jtaylo63@its.jnj.com +44 7393267595 Official trial record

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