RecruitingPhase IIInterventional

A Phase Ib/II, open-label study of amivantamab monotherapy and amivantamab in addition to other therapeutic agents in participants with head and neck squamous cell carcinoma

Head and neck cancer starts in the cells lining the mouth, nose, and throat. For many people, the cancer can return or spread after initial treatment, and better therapies are urgently needed. This clinical trial is testing a targeted medicine called amivantamab. Amivantamab works by blocking two specific proteins that help cancer cells grow and resist treatment. Researchers want to find out how safe and effective amivantamab is when used alone or combined with other cancer treatments, such as immunotherapy (pembrolizumab) or chemotherapy (paclitaxel or carboplatin). The trial is open to adults aged 18 and older who have head and neck squamous cell cancer. Depending on the group they join, participants receive treatment through an injection under the skin and, in some cases, a drip into a vein, while doctors closely monitor their health.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Janssen-Cilag International NV

Enrolment target

217

Start

14 Apr 2024

Estimated completion

30 Dec 2026

Head and neck squamous cell carcinoma

What is this study about?

Head and neck cancer usually starts in the squamous cells that line the moist surfaces inside the mouth, throat, voice box, or nose. Even though treatments have improved in recent years, this type of cancer often comes back or spreads to other areas of the body. When this happens, standard therapies may not work as well, so researchers are searching for newer, more targeted treatments.

This trial investigates a drug called amivantamab. Amivantamab is an antibody—a type of protein designed to track down and attach to specific targets in the body. It works by blocking two key proteins (called EGFR and MET) that act like fuel for cancer cells, helping them multiply and spread. By shutting down these pathways, doctors hope amivantamab can stop tumours from growing and make them more vulnerable to treatment.

In this study, doctors are looking at amivantamab on its own and in combination with other treatments. These combinations include immunotherapy, which helps the body's natural immune system fight cancer, and standard chemotherapy drugs. By testing these different options, the trial aims to find the safest and most effective approach for people with head and neck cancer.

Key takeaways

Tests a targeted drug called amivantamab, either alone or with immunotherapy and chemotherapy.
Aimed at adults with head and neck squamous cell cancer that has spread, returned, or requires surgery.
Amivantamab is given as an injection under the skin, with some treatments given via an intravenous drip.
Treatment happens in 21-day cycles with regular scans, blood tests, and safety checks.
Participation is completely voluntary and study-related travel expenses may be reimbursed.

Who may be eligible?

This trial is for adults aged 18 and over who have been diagnosed with squamous cell cancer of the head and neck. This includes cancers starting in the mouth, throat, tonsils, or voice box. In most study groups, participants have cancer that has returned or spread, and cannot be cured with local treatments like surgery alone. One group includes patients with locally advanced cancer that can be treated with surgery.

To see which group you might fit into, the study team will look closely at your past treatments and the exact location of your tumour. They will also test your tumour tissue for specific markers, such as the human papillomavirus (HPV) or related proteins like p16, as different study groups focus on HPV-positive or HPV-negative cancers.

You will need to have reasonable overall health and have standard medical checks, such as blood tests and scans, to make sure it is safe for you to take part. The trial team will review your full medical history with you to confirm your eligibility.

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.

I am 18 years of age or older.
I have been diagnosed with squamous cell carcinoma of the mouth, throat, or voice box.
My cancer has either returned, spread to other areas, or is locally advanced and suitable for surgery.
I have tumour test results available (or can have them tested) for markers like p16 or HPV.
I am well enough to attend regular hospital appointments for injections, drips, and scans.

Answer every question to see your result.

What does participation involve?

Taking part begins with a screening period lasting up to 28 days. During this time, the team will run tests such as blood work, heart traces (ECGs), and physical examinations to make sure the trial is right for you. If you join, your treatment is given in 21-day cycles. Amivantamab is given as an injection under the skin, while other study medicines (like chemotherapy or immunotherapy) are given through a drip into a vein. Some people may also receive treatment before and after surgery.

Throughout the study, you will have regular clinic visits so doctors can check your general health, monitor your blood, and do imaging scans to see how your tumour is responding. After you finish treatment, there is a follow-up period to check on your recovery and monitor your safety. This follow-up lasts between 30 and 100 days after your final dose, depending on which drugs you received. The trial will cover the cost of the study medicines and tests, and you may be reimbursed for travel and parking expenses.

Potential risks and benefits

You may benefit from taking part if the study treatments help control or shrink your cancer, and the regular check-ups provide close monitoring of your overall health. Your participation will also help doctors learn how to treat head and neck cancer better in the future. However, there is no guarantee that the treatment will work for you. Like all cancer therapies, the drugs can cause side effects. These can range from mild issues like skin rashes or tiredness, to more serious problems such as allergic reactions, lung inflammation, changes in liver function, or low blood cell counts that increase the risk of infection. Your study team will watch you closely and treat any side effects promptly. Taking part is entirely voluntary, and you are free to leave the trial at any time without your regular NHS care being affected.

Locations (6)

Royal Marsden Hospital
Approximate
Sutton, England
Addenbrookes
Approximate
Cambridge, England
The Christie Hospital
Approximate
Manchester, England
University College London Hospital
City only
London, England
Royal Surrey County Hospital
Approximate
Guildford, England
The Royal Marsden Hospital
Unverified
London, England

Common questions

What is amivantamab and how is it given?

Amivantamab is a targeted antibody designed to block two proteins that head and neck cancer cells use to grow. In this study, it is given as a quick injection under the skin.

Will I have to pay for the treatment?

No. The study sponsor covers the cost of the trial drugs and all study-related tests. You may also receive reimbursement to help cover your travel and parking costs.

Can I leave the study if I change my mind?

Yes, taking part is completely voluntary. You can decide to stop participating at any time, for any reason, and your usual medical care will not be affected.

Will I know which treatment group I am in?

Yes. This is an 'open-label' trial, which means both you and your study doctor will know exactly which medicines you are receiving.

How often will I need to visit the hospital?

Treatment is given on day one of each 21-day cycle. You will also have scheduled visits for safety monitoring, blood tests, and scans, which your study doctor will explain in detail.

How to find out more

Aoife Kelly

Official trial record

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