RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

This study is exploring new treatments for head and neck cancer that has come back or spread, and also for some advanced cancers before surgery. Researchers are testing a drug called Amivantamab, both on its own and combined with other medicines like Pembrolizumab, Paclitaxel, or Carboplatin. The main goals are to see how safe these treatments are and how well they shrink or control the cancer. Doctors are also trying to find the best dose when Amivantamab is used with Paclitaxel. For some patients who can have surgery, the study will also look at Amivantamab and Pembrolizumab given before and after their operation. This research helps us understand better ways to fight head and neck cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

287

Start

22 Apr 2024

Estimated completion

27 Dec 2032

Squamous Cell Carcinoma of Head and Neck

What is this study about?

This study is looking into new treatment options for a type of cancer called squamous cell carcinoma, which can affect the head and neck. Sometimes, this cancer can come back or spread to other parts of the body, which doctors call 'recurrent/metastatic'. The study is also looking at some advanced head and neck cancers that can be treated with surgery.

The main focus is on a new drug called Amivantamab. Researchers want to see how safe this drug is and how effective it is in slowing down or shrinking the cancer. They are testing Amivantamab in different ways: by itself, or together with other well-known cancer drugs like Pembrolizumab, Paclitaxel, and Carboplatin. Combining treatments can sometimes be more effective than using just one drug.

Part of this study involves finding the right dose for Amivantamab when it's used with Paclitaxel. This is important to ensure patients get the maximum benefit with the fewest side effects. For patients who are having surgery for their head and neck cancer, the study will also look at using Amivantamab and Pembrolizumab both before and after their operation to see if this helps improve their outcomes. This type of research helps doctors find better ways to treat head and neck cancer in the future.

Key takeaways

This study is testing a new drug, Amivantamab, for head and neck cancer.
It aims to find out if Amivantamab is safe and how well it treats cancer, alone or combined with other drugs.
Different groups of patients, including those with advanced or recurrent cancer, may be eligible.
Some patients having surgery will receive treatment before and after their operation.
Participation involves regular clinic visits for treatment and monitoring.

Who may be eligible?

To join this study, people must be at least 18 years old and have been diagnosed with squamous cell carcinoma of the head and neck. For most parts of the study, this means your cancer has either come back or spread, and can't be cured by local treatments like surgery or radiotherapy.

There are different groups within the study, and each group has slightly different rules. For example, some groups require your cancer to be negative for a certain marker called p16, especially if it's in a specific area like the throat. Other groups might specifically look for cancers linked to the HPV virus. If you have an advanced cancer that can be removed by surgery, there's also a group you might be able to join.

Overall, the specific location of your cancer (like mouth, throat, voice box), its p16 status, and sometimes its HPV status will help determine if you fit into one of the study groups. Your medical team will look at all these details to see if this study could be right for you.

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?
Has your cancer come back or spread, or is it advanced but removable by surgery?
Do you know the p16 status of your cancer (especially for throat cancers)?
Are you able to attend regular hospital visits for treatment and checks?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the study drugs (Amivantamab, possibly with Pembrolizumab, Paclitaxel, or Carboplatin) on a regular schedule. This will involve regular visits to the clinic for drug administration, usually through a drip into your vein. You'll have frequent check-ups, including physical exams, blood tests, and scans (like CT or MRI) to monitor your health and how the treatment is working. For those having surgery, there will be visits before and after the operation. The total duration of your participation will depend on how you respond to the treatment, but generally involves ongoing treatment and follow-up for a period of time.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to new treatments before they are widely available, which might help control your cancer. However, there are also risks. The experimental drugs could cause side effects, some of which may be serious or unknown. Your doctors will monitor you closely for any unwanted effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (55)

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

University of California at San Diego Moores Cancer Center
Verified postcode
La Jolla, United States· Completed
University of Colorado Denver Anschultz Medical Campus
Verified postcode
Aurora, United States· Recruiting
Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
The University of Chicago Medical Center (UCMC)
Verified postcode
Chicago, United States· Recruiting
University of Maryland School of Medicine
Verified postcode
Baltimore, United States· Recruiting
University of Michigan Rogel Cancer Center
Verified postcode
Ann Arbor, United States· Recruiting
Karmanos Cancer Institute
Verified postcode
Detroit, United States· Recruiting
Washington University School Of Medicine
Verified postcode
St Louis, United States· Recruiting
Rutgers Cancer Institute of New Jersey
Verified postcode
New Brunswick, United States· Recruiting
University of North Carolina at Chapel Hill
Verified postcode
Chapel Hill, United States· Recruiting
Cleveland Clinic
Verified postcode
Cleveland, United States· Recruiting
University of Utah Huntsman Cancer Institute
Verified postcode
Salt Lake City, United States· Recruiting

Common questions

What is Amivantamab?

Amivantamab is a new drug being tested in this study to treat head and neck cancer. It works in a specific way to target cancer cells.

What are the other drugs used in this study?

Other drugs like Pembrolizumab, Paclitaxel, and Carboplatin might be used alongside Amivantamab. These are existing cancer treatments that work in different ways.

What does 'recurrent/metastatic' mean?

This means the cancer has either returned after previous treatment or has spread to other parts of the body.

What does 'Phase 1' and 'Phase 2' mean?

Phase 1 studies first check a drug's safety. Phase 2 studies then look at how well the drug works and continue to monitor safety in more people.

Can I stop participating in the study if I want to?

Yes, you have the right to leave the study at any time, for any reason, and it won't affect your future medical care.

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.