Study of ASP-1929 and pembrolizumab for patients with recurrent head and neck squamous cell carcinoma without distant metastases

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What is this study about?

This study investigates treatments for Squamous Cell Carcinoma of the Head and Neck, specifically in cases of Locoregional Recurrence, which means the cancer has returned in the same general area where it first started, without spreading to distant parts of the body. The purpose of the study is to assess the effect on survival. Participants may receive a combination of the experimental drug ASP-1929, which is a form of Photoimmunotherapy—a method that uses light to activate a drug to target cancer cells—alongside pembrolizumab. Alternatively, participants may receive the current standard treatments, which include medications such as docetaxel, fluorouracil, carboplatin, paclitaxel, cisplatin, or pembrolizumab delivered via intravenous use, which means the medicine is administered directly into a vein through an infusion.

Who Can Join the Study?

You must provide written informed consent, which means you agree to take part in the study by signing a document after being fully informed about it.
You must be male or female and at least 18 years old at the time you sign the agreement.
You must have a confirmed diagnosis of squamous cell carcinoma, which is a type of cancer that starts in the flat cells lining the surfaces of the head or neck.
Your diagnosis must be confirmed by a pathology report, which is a document from a specialist that examines cells under a microscope to identify the disease.
The cancer must be located in the head or neck area, but it cannot be nasopharyngeal carcinoma (cancer in the upper part of the throat) or cutaneous squamous cell carcinoma (skin cancer).
In the doctor’s opinion, you must be able to receive standard first-line therapy, which is the first treatment recommended for your specific type of cancer.
The treatment recommended would be pembrolizumab, which is a type of drug that helps the immune system fight cancer, potentially used with or without chemotherapy (drugs used to kill cancer cells).
You must not have distant metastases, meaning the cancer has not spread to other far-away parts of your body.
You must have at least one tumor that can be measured and is suitable for photoimmunotherapy (PIT), a treatment that uses light to activate medicine in the tumor.
The tumor must be in a location that can be reached by light, either on the surface of the skin or slightly deeper under the skin.
The tumor cannot be in locations that are too difficult to reach with light, such as areas requiring tools to go through bone or areas directly touching major blood vessels, the eyes, or the brain.
You must not have previously used anti-PD-1 or anti-PD-L1 therapy, which are specific types of drugs used to help the immune system recognize cancer.
You must have a CPS score of 1 or higher, which is a measurement used in a laboratory test to check for certain proteins in your tumor cells that help determine if certain treatments will work.

Who Cannot Join the Study?

You cannot participate if you were diagnosed with or treated for another type of cancer (a disease where cells grow out of control) within the last 2 years, unless it was a very low-risk type that is unlikely to spread or cause death.
If you previously had a cancer that was completely removed by surgery and has not returned, you may still be able to join after a medical review.
You are not eligible if you have had a severe infusion reaction (a serious allergic-like reaction during the delivery of medicine through a vein) to the drug cetuximab in the past.
You cannot join if you have previously received an allogeneic transplantation, which means receiving tissues or solid organs from another person.
You are excluded if you have metastases (cancer that has spread from its original location) in your central nervous system (the brain and spinal cord) or if you have carcinomatous meningitis (cancer that has spread to the protective membranes covering the brain and spinal cord).
You cannot participate if your doctors estimate that you have a life expectancy (the amount of time you are expected to live) of less than 3 months.
You are not eligible if you have an active autoimmune disease (a condition where the body’s immune system attacks its own healthy cells) that required systemic treatment (medicine that travels through the entire body, such as steroids or drugs that change how the immune system works) within the past 2 years.
Using replacement therapy (such as insulin or hormones to replace what the body cannot make naturally) does not count as systemic treatment for an autoimmune disease.
You cannot join if there is evidence of interstitial lung disease (a group of conditions that cause scarring or inflammation in the lung tissue) or pneumonitis (inflammation of the lung tissue that is not caused by an infection).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Pomeranian Medical University	Szczecin	Poland

Other Sites

Site Name	City	Country
Wojewodzki Szpital Specjalistyczny We Wroclawiu	Wroclaw	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Nfwwtzpa Iubpzeja Osszqkmud Izg Melel Skhnqwcyghaennrwbahvkrprgnkp Igcrvzld Bhfwpxlr	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not yet recruiting	20.04.2026

Trial locations

Investigated drugs:

ASP-1929 is a test therapy used in this study. It is a type of photoimmunotherapy that combines a specific protein-targeting agent with light to help target and treat cancer cells.

Pembrolizumab is a medication used as a comparison in this trial. It belongs to a group of drugs known as immunotherapy, which works by helping the body’s own immune system recognize and attack cancer cells.

Docetaxel is a standard chemotherapy medication used for comparison. It works by stopping cancer cells from dividing and growing.

Fluorouracil is a standard chemotherapy medication used for comparison. It interferes with the DNA of cancer cells to prevent them from multiplying.

Carboplatin is a standard chemotherapy medication used for comparison. It is designed to damage the DNA of cancer cells to stop them from growing.

Paclitaxel is a standard chemotherapy medication used for comparison. It works by preventing cancer cells from dividing properly, which leads to cell death.

Cisplatin is a standard chemotherapy medication used for comparison. It helps to stop the growth of cancer cells by interfering with their genetic material.

Investigated diseases:

Squamous cell carcinoma of head and neck

Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck – This condition occurs when squamous cell carcinoma, a type of cancer starting in the flat cells lining various surfaces, returns to the area where it was originally found. The cancer cells grow within the head and neck region, such as the mouth, throat, or larynx. This recurrence can involve the local tissue or nearby lymph nodes. As the disease progresses, the abnormal cells continue to multiply and may spread to adjacent structures in the head and neck area.

Trial ID:

2025-523017-28-00

Protocol code:

ASP-1929-381

NCT ID:

NCT06699212

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of ASP-1929 and pembrolizumab for patients with recurrent head and neck squamous cell carcinoma without distant metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?