Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Setanaxib and Pembrolizumab for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Fast replyRegistered 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 a type of cancer known as recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). This cancer can return after treatment or spread to other parts of the body. The study is testing a new treatment combination to see if it can help patients with this condition. The treatment involves two medications: Setanaxib, which is taken as a film-coated tablet, and Pembrolizumab, which is given as an intravenous infusion. Pembrolizumab is a type of medication known as a PD-1 inhibitor, which helps the immune system fight cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of Setanaxib when used together with Pembrolizumab. Participants in the study will be randomly assigned to receive either the combination of Setanaxib and Pembrolizumab or a placebo and Pembrolizumab. The study will last for a period of up to 105 days, during which the participants will receive regular treatments and have their tumor sizes monitored. The study aims to see if the combination of Setanaxib and Pembrolizumab can reduce the size of the tumors more effectively than Pembrolizumab alone.

Throughout the study, participants will undergo various assessments to monitor their health and the effects of the treatment. These assessments will include regular check-ups and imaging tests to measure changes in tumor size. The study will also look at specific markers in the tumor tissue to understand how the treatment affects the cancer at a molecular level. The results of this study will help determine if this new treatment combination could be a beneficial option for patients with recurrent or metastatic SCCHN.

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

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.

  2. Step 2

    Treatment administration

    The patient will receive either the NOX1/4 inhibitor setanaxib or a placebo in combination with pembrolizumab. Setanaxib is administered orally in the form of film-coated tablets, while pembrolizumab is given as an intravenous infusion.

    The dosage and frequency of administration will be determined by the study protocol, and the patient will be informed of the specific schedule.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will undergo regular monitoring to assess the treatment's effects on tumour size and other health indicators. This includes imaging tests and laboratory evaluations.

    The primary goal is to observe any changes in tumour size according to specific criteria, known as RECIST v1.1, which helps in evaluating the response to treatment.

  4. Step 4

    Biopsy and biomarker analysis

    The patient will have a tumour biopsy before and during the treatment to analyze specific biomarkers. This helps in understanding the treatment's impact on tumour characteristics and immune response.

    The study will measure changes in certain cells within the tumour tissue, such as CAFs and CD8+ TILs, which are indicators of the body's immune response to cancer.

  5. Step 5

    Follow-up and conclusion

    After completing the treatment phase, the patient will continue to be monitored for any long-term effects and overall health status. This follow-up period is crucial for gathering comprehensive data on the treatment's safety and effectiveness.

    The study is expected to conclude by October 31, 2025, at which point all collected data will be analyzed to determine the outcomes of the trial.

Who can join the trial?

20 criteria

  • Patients must be at least 18 years old.
  • Patients should have a good general health status, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status, with a score of 0 or 1. This means they are fully active or have some symptoms but can still do light work.
  • Patients need to have proper functioning of their organs and bone marrow, which is the soft tissue inside bones that makes blood cells. This includes:
    • A certain level of white blood cells called neutrophils to fight infections.
    • A certain number of platelets, which help with blood clotting.
    • A certain level of hemoglobin, which carries oxygen in the blood.
    • Normal levels of bilirubin, a substance made by the liver.
    • Normal levels of liver enzymes called AST and ALT.
    • Normal kidney function, measured by serum creatinine or creatinine clearance.
    • Women who can have children must use a very effective method of birth control starting at least 4 weeks before joining the study and continue for 120 days after the last treatment. This includes methods like hormonal birth control, an intrauterine device (IUD), or having a partner who has had a vasectomy.
    • Women who can have children must have a negative pregnancy test before starting the study.
    • Men with female partners who can have children must use a condom and ensure their partner uses a highly effective birth control method during the study and for 120 days after the last treatment.
    • Men must not donate sperm, and women must not donate eggs during the study and for 120 days after the last treatment.
    • Patients must agree to participate in the study and follow its requirements.
    • Patients must have a confirmed diagnosis of Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has come back or spread to other parts of the body and cannot be removed by surgery.
    • Patients should be suitable for first-line treatment with a drug called pembrolizumab for their condition.
    • Patients must have a certain level of CAFs in their tumor, which is a specific marker checked in a lab.
    • Patients must have a measurable disease, meaning the tumor can be measured and is large enough for a biopsy, which is a small sample taken for testing.
    • Patients must have a Combined Positive Score (CPS) of at least 1, which is a measure of certain proteins in the tumor.
    • Patients must know their HPV status, which is whether they have a virus called human papillomavirus, at the time they start the study.
    • Patients should have a life expectancy of at least 6 months, as judged by the doctor.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not experienced a return or spread of their cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications.
  • Patients who are unable to provide informed consent.
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

  • Setanaxib

    is a medication being studied for its potential to inhibit certain enzymes that may contribute to the growth of tumors. In this trial, it is being tested to see if it can help reduce the size of tumors in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's 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 in combination with setanaxib to evaluate if the combination is more effective than pembrolizumab alone.

What is already known about the treatment

  • Setanaxib

    Setanaxib is administered orally and is currently being studied in clinical trials for its potential use in treating recurrent or metastatic squamous cell carcinoma of the head and neck. It is a NOX1/4 inhibitor, which means it works by blocking specific enzymes that contribute to the growth and spread of cancer cells. This medication is classified as an enzyme inhibitor and is being evaluated for its effectiveness in reducing tumor size when used in combination with other treatments.

  • Pembrolizumab

    Pembrolizumab is given as an intravenous infusion and is an established medication in the treatment of various cancers, including recurrent or metastatic squamous cell carcinoma of the head and neck. It is a PD-1 inhibitor, which helps the immune system recognize and attack cancer cells by blocking a pathway that restricts immune response. Pembrolizumab is classified as an immune checkpoint inhibitor and is widely used in oncology for its ability to enhance the body's natural defenses against cancer.

Investigated diseases

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that originates in the squamous cells lining the head and neck region. It can recur after initial treatment or spread to other parts of the body, known as metastasis. The disease often begins in areas such as the mouth, throat, or voice box. As it progresses, it may cause symptoms like persistent sore throat, difficulty swallowing, or changes in voice. The cancer can invade nearby tissues and organs, leading to more complex symptoms. Over time, it may affect the patient's ability to eat, speak, or breathe normally.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509917-35-00Protocol codeGSN000400Estimated enrolment48 patientsSponsorCalliditas Therapeutics Suisse S.A.

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.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).