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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study assignment

    After joining the study, a group is assigned to receive either the test treatment or the standard of care.

    The test treatment consists of the medication asp-1929, which is given as an intravenous injection (delivered into a vein) at a dose of 640 mg/m2 (milligrams per square meter of body surface area), combined with light illumination using the pit690 laser system.

    The standard of care group receives the current regular medical treatments, which may include several different medications delivered through intravenous infusion (delivered through a vein).

  2. Step 2

    Medication administration for standard of care

    The standard of care may involve the administration of pembrolizumab at a dose of 400 mg via intravenous infusion.

    Other possible medications in this group include docetaxel at a dose of 75 mg/m2, fluorouracil at a dose of 1000 mg/m2, carboplatin at a dose of 5 mg/ml, paclitaxel at a dose of 175 mg/m2, or cisplatin at a dose of 100 mg/m2, all administered through intravenous infusion.

  3. Step 3

    Monitoring and evaluation

    During the trial, the effectiveness of the treatment is monitored by measuring overall survival, which is the time from the start of group assignment until death from any cause.

    The response of the cancer to the treatment is also evaluated to determine the complete response rate (when all signs of cancer disappear) and the objective response rate (the proportion of patients whose cancer shrinks or disappears).

Who can join the trial?

13 criteria

  • 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 trial?

9 criteria

  • 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).
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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.

What is already known about the treatment

  • Docetaxel

    This medication is a chemotherapy drug administered as an intravenous infusion to treat various types of cancer. It is a well-established treatment in medical practice that works by stopping cancer cells from dividing, specifically by interfering with the internal structure that allows cells to split. It belongs to a class of drugs known as taxanes.

  • Fluorouracil

    This drug is given through an intravenous injection or infusion and is widely used to treat several types of solid tumors. It acts as an antimetabolite, which means it mimics the building blocks of DNA to trick and kill rapidly growing cancer cells. It is classified as a chemotherapy agent.

  • Carboplatin

    This chemotherapy medication is administered via intravenous infusion to treat many different types of cancer. It works at a molecular level by binding to the DNA of cancer cells, which prevents them from replicating and ultimately leads to cell death. It belongs to a group of drugs called platinum-based antineoplastic agents.

  • Paclitaxel

    This medication is an intravenous infusion used commonly in the treatment of various cancers. It functions by stabilizing the internal framework of cells, which prevents cancer cells from dividing and growing. It is pharmacologically classified as a taxane.

  • Cetuximab sarotalocan

    This is an investigational drug administered through an intravenous injection as part of a specialized light-based therapy. It is designed to target specific proteins on the surface of cancer cells to make them more susceptible to being destroyed by light. It is classified as an experimental photoimmunotherapy agent.

  • Cisplatin

    This is a standard chemotherapy drug delivered through an intravenous infusion for the treatment of several cancers. It works by attaching to the DNA inside cancer cells, causing damage that triggers cell death. It belongs to the classification of platinum-based chemotherapy drugs.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523017-28-00Protocol codeASP-1929-381Estimated enrolment412 patientsSponsorRakuten Medical Inc.

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