AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases

This research study is for people in the UK who have squamous cell carcinoma of the head and neck (a type of head and neck cancer) that has returned in the same region after previous treatment, but hasn't spread to other parts of the body. The study is comparing a new treatment called ASP-1929 Photoimmunotherapy, given together with another drug called Pembrolizumab, against the usual standard treatments doctors currently use. The main goal is to see if the new combination treatment helps people live longer. Researchers will also look at how many people see their cancer shrink or disappear and how safe the treatments are. It's a 'Phase 3' study, meaning it's a larger trial aiming to confirm if this new treatment is better than what's currently available.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Rakuten Medical Inc.

Enrolment target

Start

03 Apr 2026

Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC)

What is this study about?

This study is for adults diagnosed with a type of cancer called squamous cell carcinoma of the head and neck. This is when the cancer has returned in the area it started in (like the mouth, throat, or voice box) after previous treatment, but importantly, it hasn't spread to distant parts of the body. The research aims to find out if a new combination treatment works better than the standard treatments currently used.

The new combination involves two treatments: ASP-1929 Photoimmunotherapy and a drug called Pembrolizumab (also known as Keytruda). Pembrolizumab is an immunotherapy drug that helps your body’s immune system fight cancer. ASP-1929 Photoimmunotherapy is a newer approach that uses light to activate a special drug (ASP-1929) to target and destroy cancer cells. Researchers want to see if combining these two treatments is more effective than standard chemotherapy options.

The core purpose of this study is to compare how long people live when having the new combination treatment versus when they receive standard treatments. They will also be looking at how well the cancer responds to each treatment, for example, if it shrinks or disappears. This is a Phase 3 study, which means it’s one of the final stages of testing to confirm if the new treatment is safe and more effective than existing options, potentially leading to it becoming a new standard treatment option in the future.

Key takeaways

New study for head and neck cancer that has returned.
Compares a new combination treatment to standard care.
Investigates ASP-1929 Photoimmunotherapy combined with Pembrolizumab.
Aims to see if the new treatment helps people live longer and is effective.
For adults with local recurrence, not spread to distant sites.
Participation involves random assignment to a treatment group.

Who may be eligible?

To join this study, you must be an adult, aged 18 or older. Both men and women can take part.

Key to eligibility is that you have a specific type of head and neck cancer (squamous cell carcinoma) that has come back in the local area or nearby lymph nodes. Importantly, the cancer must not have spread to other, more distant parts of your body, like your lungs or liver.

There will be other medical checks and tests to make sure the study treatment is safe and suitable for your overall health. Your doctor will discuss all the detailed requirements with you to see if you are a good fit for this research.

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?
Have you been diagnosed with squamous cell carcinoma of the head and neck?
Has your cancer come back in the same area or nearby? (Locoregional recurrence)
Has your cancer NOT spread to other parts of your body (no distant metastases)?
Are you currently in good general health, apart from your cancer diagnosis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening period to check if you meet all the requirements. If you do, you would be randomly assigned to one of two groups: either receiving the new combination treatment (ASP-1929 Photoimmunotherapy plus Pembrolizumab) or one of the standard chemotherapy treatments. This means you wouldn't get to choose which treatment you receive. Regular hospital visits would be needed for your treatments, which are given directly into your vein (infusion), and for check-ups and tests. These tests might include blood tests, scans (like CT or MRI), and physical examinations, to monitor your health and how well the treatment is working. The total time you spend in the study, including treatments and follow-up, will depend on how you respond to the treatment and your overall health, but it could last for many months to a few years. You would continue to be monitored even after your active treatment stops.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new treatment combination that isn't widely available yet, which could be more effective than current options for your type of cancer. However, there are also potential risks, as all medical treatments can have side effects. Doctors will monitor you closely for any unwanted effects, which can vary depending on the specific drugs. Your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

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Unverified
Poland

Common questions

What is squamous cell carcinoma of the head and neck?

It's a type of cancer that starts in the flat cells lining the moist surfaces inside the head and neck area, such as the mouth, throat, or voice box.

What does 'locoregional recurrence' mean?

This means the cancer has come back in the same general area where it first appeared, or in nearby lymph nodes, after having been treated before.

What is 'Photoimmunotherapy'?

It's a newer type of treatment that uses light to activate a special drug (ASP-1929) to specifically target and destroy cancer cells while trying to leave healthy cells alone.

What is Pembrolizumab (Keytruda)?

It's a powerful drug that helps your body's own immune system find and fight cancer cells more effectively. It's a type of immunotherapy.

Why is this study being done?

The study aims to see if combining a new light-activated treatment with an immunotherapy drug is better at treating this type of recurring head and neck cancer than the standard treatments currently available.