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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario De Navarra	Pamplona	Spain
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France

Other Sites

Site Name	City	Country
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Ramsay Generale De Sante	Bayonne	France
Universita Degli Studi Di Brescia	Brescia	Italy
CHU Bordeauxt	Bordeaux	France
Cmyaty Ldyl Byvrwx	Lyon	France
Nowtdwlf Iagqbrjx Oquwqeahd Icl Mjpnq Sgjwkkniudgaawgsjukbcypbedhy Iulssflk Bsmzfgsh	Cracow	Poland
Fefzdfuwi Phfn Lb Ilwfpxbhuwggb Bpetvrxwr Dlf Hltpekfo Uahbwuynjowpv Ls Paj	Madrid	Spain
Cehhca Ohpem Lwntjgb	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.12.2021
Italy	Not recruiting	01.12.2021
Poland	Not recruiting	01.12.2021
Spain	Not recruiting	01.12.2021

Trial locations

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.

Investigated diseases:

Squamous cell carcinoma of head and neck

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 ID:

2023-509917-35-00

Protocol code:

GSN000400

NCT ID:

NCT05323656

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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Who Cannot Join the Study?