Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and Pembrolizumab for Patients with Advanced Head and Neck Cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying treatments for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC). The study will explore the effects of different treatment combinations, including TransCon TLR7/8 Agonist used with pembrolizumab, TransCon TLR7/8 Agonist combined with TransCon IL-2 β/γ, and pembrolizumab alone. Pembrolizumab is a medication that helps the immune system fight cancer cells, while TransCon TLR7/8 Agonist and TransCon IL-2 β/γ are investigational drugs being tested for their potential to enhance the immune response against cancer.

The purpose of this study is to evaluate how well these treatments work in reducing the size of the cancer before surgery. Participants will receive one of the treatment options, which may involve receiving the medication through an infusion into a vein or an injection directly into the tumor. The study will last for a period of up to 42 days, during which participants will be closely monitored by healthcare professionals. The goal is to determine which treatment is most effective in preparing the cancer for surgical removal.

Throughout the study, participants will undergo regular assessments to monitor their health and the response of the cancer to the treatment. These assessments will help researchers understand the potential benefits and any side effects of the treatments being tested. The information gathered from this trial will contribute to the development of more effective therapies for patients with LA-HNSCC.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and tumor characteristics.

    Informed consent is required, ensuring understanding of the study's requirements and restrictions.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to one of three treatment groups: TransCon TLR7/8 Agonist with pembrolizumab, TransCon TLR7/8 Agonist with TransCon IL-2 β/γ, or pembrolizumab alone.

    The purpose is to evaluate the effectiveness of these treatments as neoadjuvant therapy for head and neck cancer.

  3. Step 3

    Treatment administration

    TransCon TLR7/8 Agonist is administered via intratumoral injection.

    Pembrolizumab is given as an intravenous infusion, with a concentration of 25 mg/mL.

    TransCon IL-2 β/γ is also administered through intravenous infusion.

    The frequency and duration of these treatments are determined by the study protocol.

  4. Step 4

    Monitoring and assessments

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

    Assessments include imaging and biopsies to evaluate tumor response and progression.

  5. Step 5

    Surgery

    Participants undergo surgery to remove the tumor, as planned based on the study protocol and local practice.

    The effectiveness of the treatment is evaluated through pathological examination of the resected tumor.

  6. Step 6

    Follow-up

    Post-surgery, participants are monitored for any recurrence of the disease and overall survival.

    The study continues to track the incidence and severity of any adverse events.

Who can join the trial?

12 criteria

  • Participants must be at least 18 years old at the time of signing the consent form.
  • Must have at least one area that can be easily and safely accessed for an injection directly into the tumor.
  • For women who can have children: Must agree to avoid pregnancy by not having heterosexual intercourse or using very effective birth control methods, and must not donate eggs from the time of a negative pregnancy test before the study, during the study, and for 160 days after the last dose of the study drug.
  • For men with a female partner who can have children or is pregnant: Must agree to avoid pregnancy by not having heterosexual intercourse or using a double method of birth control (like a condom and spermicide), and must not donate sperm during the study and for 160 days after the last dose of the study drug.
  • Must be able to give signed consent, agreeing to follow the study's requirements and restrictions.
  • Must have a new diagnosis of a type of head and neck cancer that can be surgically removed and has not spread to other parts of the body. This includes specific stages and types of tumors as defined by medical guidelines.
  • Must have a sample of the tumor available from a previous or new biopsy. A fine needle biopsy may be allowed after discussion with the study's medical team.
  • Must be eligible and planning to have surgery for the head and neck cancer based on the doctor's decision and local medical practices.
  • Must have results from testing the tumor for HPV (a virus) status using specific medical tests.
  • Must have adequate organ function, which includes specific levels of substances in the blood like bilirubin, liver enzymes, creatinine, blood cells, and thyroid hormones.
  • Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures the ability to perform daily activities.
  • In the opinion of the doctor, must be able to follow the treatment schedule and required assessments without delaying the planned surgery.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • TransCon TLR7/8 Agonist

    is a medication being studied for its potential to help the immune system fight cancer. It works by activating certain receptors in the body that can enhance the immune response against cancer cells. In this trial, it is being tested in combination with other treatments to see if it can improve outcomes for patients with head and neck cancer.

  • Pembrolizumab

    is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is already used in the treatment of various types of cancer, including head and neck cancer. In this trial, it is being used both alone and in combination with other medications to evaluate its effectiveness in treating advanced head and neck cancer.

  • TransCon IL-2 β/γ

    is an investigational therapy designed to stimulate the immune system by increasing the activity of certain immune cells. It is being tested in combination with the TransCon TLR7/8 Agonist to determine if this combination can enhance the body's ability to fight cancer more effectively than other treatments.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion. It is currently approved and widely used in medicine, with extensive documentation in medical literature. The main therapeutic indication for pembrolizumab in this trial is as a neoadjuvant therapy for Stage III-IVA resectable locoregionally advanced head and neck squamous cell carcinoma. It works by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor.

  • TransCon TLR7/8 Agonist

    This medication is administered through injection. It is currently under investigation in clinical trials and is not yet approved for general medical use. The main therapeutic indication in this trial is for use in combination with other treatments for Stage III-IVA resectable locoregionally advanced head and neck squamous cell carcinoma. It works by activating TLR7 and TLR8 receptors, which are part of the immune system, to stimulate an immune response against cancer cells. It is classified as an immune system modulator.

  • TransCon IL-2 β/γ

    This medication is administered through injection. It is currently being studied in clinical trials and is not yet approved for widespread medical use. The main therapeutic indication in this trial is for use in combination with other treatments for Stage III-IVA resectable locoregionally advanced head and neck squamous cell carcinoma. It functions by delivering a modified form of interleukin-2, which helps to boost the immune system's ability to fight cancer. It is classified as an immune system modulator.

Investigated diseases

Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC) – This is a type of cancer that occurs in the squamous cells lining the head and neck region. It is considered advanced when it has spread to nearby tissues or lymph nodes but is still potentially removable through surgery. The disease often begins with symptoms like a persistent sore throat, difficulty swallowing, or a lump in the neck. As it progresses, it may cause more severe symptoms, including changes in voice, unexplained weight loss, or persistent ear pain. The progression of this cancer can vary, with some cases remaining localized while others may spread to distant parts of the body.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506092-10-00Protocol codeASND0038Estimated enrolment92 patientsSponsorAscendis Pharma Oncology Division A/S

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.