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Study of eftilagimod alpha with pembrolizumab combination therapy for patients with metastatic head and neck cancer who have not received previous treatment

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on treating patients with metastatic head and neck squamous cell carcinoma (HNSCC), a type of cancer that has spread beyond its original location and cannot be cured with local treatments. The study examines a combination therapy using two medications: pembrolizumab (also known as KEYTRUDA) and eftilagimod alfa (also known as IMP321).

The purpose of this research is to evaluate how well these two medications work together compared to using pembrolizumab alone in treating head and neck cancer. Pembrolizumab is given through an intravenous infusion into a vein, while eftilagimod alfa is given as an injection under the skin (subcutaneous injection). The treatment period can last up to 24 months.

During the study, participants will be divided into groups, with some receiving both medications while others receive only pembrolizumab. The medications work by helping the body's immune system fight cancer cells. Doctors will monitor how the cancer responds to treatment through regular medical examinations and imaging tests.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo medical tests to confirm your eligibility for the study. This includes blood tests and verification of your head and neck cancer diagnosis.

    A tissue sample will be required to test for specific markers (PD-L1 and HPV status for throat cancer).

    The medical team will review your medical history and perform a physical examination.

  2. Step 2

    Treatment assignment

    You will be assigned to receive either the combination treatment or standard treatment.

    The combination treatment includes two medications:

    - Pembrolizumab (Keytruda): given through an intravenous infusion

    - Eftilagimod alfa: given as an injection under the skin

  3. Step 3

    Treatment period

    Regular visits will be scheduled for treatment administration and monitoring.

    Your response to treatment will be assessed through imaging scans.

    Blood tests will be performed to monitor your health status.

    You will complete quality of life questionnaires during the study.

  4. Step 4

    Safety monitoring

    Your health will be monitored for any side effects throughout the treatment period.

    Regular physical examinations and laboratory tests will be conducted.

    An ECG (heart test) will be performed periodically.

    You should report any new symptoms or health changes to the medical team.

  5. Step 5

    Follow-up period

    After completing treatment, you will continue to be monitored for safety and treatment effectiveness.

    Regular check-ups will be scheduled to assess your health status.

    The study will continue until October 2025.

Who can join the trial?

10 criteria

  • Must be at least 18 years old and willing to provide written informed consent
  • Must have measurable cancer that can be evaluated using specific imaging criteria
  • Must have head and neck cancer that has spread and cannot be cured with local treatments
  • Must have adequate organ function as shown by blood tests: - Sufficient white blood cells - Sufficient platelets - Sufficient hemoglobin (oxygen-carrying protein) - Normal kidney and liver function
  • Must provide a tissue sample for laboratory testing of specific markers (PD-L1 and HPV for throat cancer)
  • Must have good physical function (ECOG score 0-1, meaning able to perform daily activities)
  • If positive for Hepatitis B, must be on antiviral treatment with undetectable virus levels
  • If positive for Hepatitis C, must have undetectable virus levels
  • If HIV positive, must be on stable treatment with good immune cell counts and controlled virus levels
  • For women who can become pregnant: - Must have negative pregnancy test - Must use effective birth control during the study and for 4 months after - Or must be post-menopausal/surgically sterile

Who cannot join the trial?

15 criteria

  • Prior treatment with any anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy (immunotherapy medications that target specific proteins)
  • Active brain metastases (cancer that has spread to the brain) or other central nervous system tumors
  • Uncontrolled medical conditions that could interfere with treatment, including:
    • Severe heart disease
    • Uncontrolled high blood pressure
    • Active infections
    • Known autoimmune disease (condition where the immune system attacks healthy cells), except for:
      • Controlled type 1 diabetes
      • Skin conditions not requiring systemic treatment
      • Thyroid disorders controlled with medication
      • History of other cancers within 5 years before starting the study, except for:
        • Successfully treated non-melanoma skin cancer
        • Successfully treated cervical cancer
        • Pregnant or breastfeeding women
        • Known HIV, hepatitis B, or hepatitis C infection
        • Receipt of live vaccines within 30 days before starting treatment
        • Current participation in other clinical trials
        • Unable to give informed consent or follow study procedures
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Investigated drugs

Eftilagimod alpha (also known as efti or IMP321) is a soluble LAG-3 fusion protein that works as an immunotherapy treatment. It helps activate the immune system to fight cancer cells. This medication is designed to boost the body's natural defense mechanisms against head and neck cancer. Pembrolizumab is an immunotherapy medication that works as a PD-1 antagonist. It helps the immune system recognize and attack cancer cells. This medication is already used in cancer treatment and works by blocking certain proteins that can hide cancer cells from the immune system. The trial studies these medications both individually and in combination to treat squamous cell carcinoma of the head and neck (HNSCC), which is a type of cancer. The combination of these two medications is being tested to see if they work better together than pembrolizumab alone.

What is already known about the treatment

  • Eftilagimod alpha

    A soluble LAG-3 fusion protein administered as an injectable medication that works as an immunotherapeutic agent for cancer treatment. It is currently being investigated in clinical trials for the treatment of metastatic head and neck squamous cell carcinoma (HNSCC) in combination with pembrolizumab. The medication functions by modulating the immune system's response to cancer cells, specifically targeting the LAG-3 pathway to enhance anti-tumor immune responses.

  • Pembrolizumab

    An immunotherapy medication administered through intravenous infusion that belongs to the class of PD-1 inhibitors. It works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. This medication is already approved for various cancer types and is being studied in combination with eftilagimod alpha for first-line treatment of unresectable recurrent or metastatic head and neck squamous cell carcinoma.

Investigated diseases

Head and Neck Squamous Cell Carcinoma (HNSCC) - A type of cancer that begins in the flat squamous cells that line the moist surfaces inside the head and neck area. The disease typically starts in the cells lining the mouth, nose, throat, or voice box. As it progresses, cancer cells can spread to nearby tissues and form larger tumors. When the disease becomes metastatic, it means cancer cells have spread from their original location to other parts of the body. The cancer commonly spreads first to the lymph nodes in the neck before potentially reaching distant organs. This disease can affect various functions including speaking, swallowing, and breathing depending on its location.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510762-16-00Protocol codeTACTI-003Estimated enrolment171 patientsSponsorImmutep

sourced from the EU Clinical Trials Register and site verification

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