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Study of ALX148, Pembrolizumab, and Chemotherapy for Patients with Advanced Head and Neck Cancer

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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called advanced head and neck squamous cell carcinoma. This cancer can be difficult to treat, especially when it has spread to other parts of the body or cannot be removed by surgery. The study is testing a combination of treatments to see how well they work together. The treatments being tested include a medication called ALX148, another medication known as pembrolizumab (also called Keytruda), and chemotherapy drugs. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to evaluate how effective this combination of treatments is in improving the survival rate and response to treatment in patients who have not yet received treatment for their advanced cancer. Participants in the study will receive these treatments through an intravenous (IV) line, which means the medication is given directly into a vein. The study will last for up to 24 months, during which time the effects of the treatment will be closely monitored.

Throughout the study, researchers will assess various outcomes, such as how long patients live after starting the treatment and how well the cancer responds to the treatment. They will also monitor any side effects that may occur. This information will help determine if the combination of ALX148, pembrolizumab, and chemotherapy is a beneficial treatment option for patients with advanced head and neck squamous cell carcinoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A biopsy sample is required for central confirmation of PD-L1 status and evaluation of other biomarkers.

  2. Step 2

    Screening tests

    Screening tests are performed to ensure all health criteria are met. These include blood tests to check bone marrow, liver, and kidney function.

    A pregnancy test is conducted for females of childbearing potential.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of pembrolizumab and ALX148 through intravenous infusion.

    Chemotherapy drugs, including 5FU and a platinum-based drug (either carboplatin or cisplatin), are also administered.

  4. Step 4

    Treatment schedule

    The treatment is given in cycles. Each cycle lasts for a specified period, during which the medications are administered according to the study protocol.

    The exact dosage and frequency of administration are determined by the study guidelines and the patient's response to treatment.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and manage any side effects.

    Follow-up visits include physical exams, imaging tests, and laboratory tests to evaluate the effectiveness of the treatment.

  6. Step 6

    End of treatment

    The treatment continues until the study's end date or until it is determined that the treatment is no longer beneficial.

    A final assessment is conducted to evaluate the overall response to the treatment.

Who can join the trial?

17 criteria

  • Patients must have a type of cancer called metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) and should not have received treatment for their advanced disease.
  • Patients must have a test result available that shows their PD-L1 status, which is a protein that can affect how the immune system responds to cancer.
  • Patients should not have received any previous treatment for their metastatic or recurrent disease. However, they can have had treatment for earlier stages of the disease if it was completed more than 6 months before joining the study.
  • Patients must have recovered from any side effects of previous treatments to a mild level, except for side effects that are not considered risky, like hair loss.
  • A sample from a previous biopsy, which is a small tissue sample taken for testing, must be available for study purposes. This sample should ideally be taken after the most recent treatment for HNSCC.
  • Women who can have children must have a negative pregnancy test before starting the study.
  • Both men and women who can have children must agree to use effective birth control during the study and for a certain period after the study ends.
  • Patients must provide a signed consent form indicating they understand the study and agree to participate.
  • Patients must be willing and able to attend scheduled visits and follow the study procedures.
  • Patients must have at least one measurable tumor that can be tracked during the study.
  • Patients must have adequate bone marrow function, which means their blood cell levels must be within a certain range.
  • Patients must have adequate kidney function, which means their kidneys must be working well enough to handle the study treatments.
  • Patients must have adequate liver function, which means their liver must be working well enough to handle the study treatments.
  • Patients must be at least 18 years old, unless the local regulations require a higher minimum age.
  • Patients must have certain blood clotting levels unless they are on medication that affects these levels.
  • Patients must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • Patients with a specific type of cancer called oropharyngeal carcinoma must have test results showing their HPV (p16) status, which is related to a virus that can affect cancer.

Who cannot join the trial?

4 criteria

  • Patients who have already received treatment for their advanced disease cannot participate.
  • Patients with medical conditions other than **metastatic or unresectable, recurrent HNSCC** are not eligible. **Metastatic** means the cancer has spread to other parts of the body. **Unresectable** means the cancer cannot be removed with surgery. **Recurrent** means the cancer has come back after treatment. **HNSCC** stands for head and neck squamous cell carcinoma, a type of cancer in the head and neck area.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population may not be eligible. A **vulnerable population** includes groups who may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

  • ALX148

    is an investigational medication being studied for its potential to help the immune system fight cancer. It is used in combination with other treatments to see if it can improve outcomes for patients with advanced head and neck cancer.

  • Pembrolizumab

    is a type of immunotherapy that helps the body's immune system recognize and attack cancer cells. It is used in this study to see if it can improve survival rates and response rates in patients with advanced head and neck cancer.

  • 5FU

    (5-Fluorouracil) is a chemotherapy drug that works by interfering with the growth and spread of cancer cells. It is used in combination with other treatments to see if it can enhance the effectiveness of the therapy for patients with advanced head and neck cancer.

  • Carboplatin

    is a chemotherapy medication that helps to stop the growth of cancer cells. It is being tested in this study to determine its effectiveness when used with other treatments for advanced head and neck cancer.

  • Cisplatin

    is another chemotherapy drug that works by damaging the DNA of cancer cells, which can lead to their death. It is used in this study to evaluate its role in combination with other therapies for treating advanced head and neck cancer.

What is already known about the treatment

  • ALX148

    This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced head and neck squamous cell carcinoma (HNSCC). It is being evaluated in combination with pembrolizumab and chemotherapy. ALX148 works by blocking a protein that helps cancer cells evade the immune system, thereby enhancing the body's ability to fight cancer. It is classified as an immune checkpoint inhibitor.

  • Pembrolizumab

    Administered through intravenous infusion, pembrolizumab is an established medication in the treatment of various cancers, including advanced head and neck squamous cell carcinoma. It is an immune checkpoint inhibitor that works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. Pembrolizumab is widely used in oncology and has been extensively documented in medical literature.

  • 5-Fluorouracil (5FU)

    This medication is given intravenously and is a well-known chemotherapy drug used in the treatment of various cancers, including head and neck squamous cell carcinoma. It works by interfering with the DNA synthesis of cancer cells, preventing their growth and division. 5-Fluorouracil is classified as an antimetabolite and has been a staple in cancer treatment for many years.

  • Carboplatin

    Administered intravenously, carboplatin is a chemotherapy drug used to treat various types of cancer, including head and neck squamous cell carcinoma. It works by damaging the DNA of cancer cells, which inhibits their ability to divide and grow. Carboplatin is classified as a platinum-based chemotherapy agent and is well-documented in medical literature.

  • Cisplatin

    This medication is given intravenously and is a widely used chemotherapy drug for treating different cancers, including head and neck squamous cell carcinoma. Cisplatin works by forming cross-links in DNA, which prevents cancer cells from dividing and growing. It is classified as a platinum-based chemotherapy agent and has been a cornerstone in cancer treatment for decades.

Investigated diseases

Head and Neck Squamous Cell Carcinoma (HNSCC) – This is a type of cancer that arises from the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, throat, and nose. It can become metastatic, meaning it spreads to other parts of the body, or unresectable, indicating it cannot be removed surgically. The disease may recur after initial treatment, leading to a recurrent form. As it progresses, patients may experience symptoms like difficulty swallowing, persistent sore throat, or changes in voice. The progression of HNSCC can vary, with some cases advancing more rapidly than others.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508342-17-00Protocol codeAT148004Estimated enrolment162 patientsSponsorAlx Oncology Holdings Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).