Squamous Cell Carcinoma of Head and NeckPhase 2NCT05323656
A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
A Phase 2 study testing Setanaxib and Pembrolizumab in people with Squamous Cell Carcinoma of Head and Neck, run by Calliditas Therapeutics Suisse SA at 24 sites in 7 countries.
Trial summary
The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Setanaxib and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 6 Apr 2022to 21 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years, inclusive, at the time of informed consent.
- Willing and able to give informed consent and to comply with the requirements of the study.
- Histologically- or cytologically-confirmed diagnosis of SCCHN that is recurrent or metastatic with or without nodal involvement, and with or without metastatic spread, and is not eligible for surgical resection.
- Candidates for first-line treatment for pembrolizumab for recurrent or metastatic SCCHN, at the discretion of the investigator.
- A positive CAFs level (defined as CAFs level in tumours ≥5%), performed at a central laboratory, with fresh tumour biopsy taken during or within 30 days prior to the Screening Period. If available, suitable archival tissue (taken within 6 months prior to the Screening Visit and where the patient has received no further anti-cancer therapy during this 6-month period) can be used to assess tumour CAFs level and determine patient eligibility.
- Measurable disease, in accordance with RECIST v1.1, and with tumour accessible and of sufficient volume for pre-treatment and on-treatment biopsy.
Show all 24Show fewer
- Combined positive score (CPS) ≥1, as determined on the archival or fresh tumour biopsy taken during or within 30 days prior to the Screening Period.
- HPV status known at randomisation.
- Life expectancy of at least 6 months in the judgment of the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function within 35 days of starting study treatment. Criteria "a" to "c" cannot be met in patients with ongoing or recent (within 14 days of screening test) transfusions or who require ongoing growth factor support:
- Absolute neutrophil count ≥1,000/mm3 (≥ 1.0×109/L).
- Platelet count ≥100,000/mm3 (≥ 100×109/L).
- Haemoglobin ≥9 g/dL, in the absence of transfusions for at least 2 weeks. Patients requiring ongoing transfusions or growth factor support to maintain haemoglobin ≥ 9g/dL are not eligible.
- Total bilirubin ≤1.5×upper limit of normal (ULN) (if associated with liver metastases or Gilbert's disease, ≤3×ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN.
- Serum creatinine ≤2.0 mg/dL or creatinine clearance ≥40 mL/min (measured or calculated according to the method of Cockcroft and Gault).
- Female patients of childbearing potential must use a highly effective method of contraception to prevent pregnancy for ≥4 weeks before randomisation and must agree to continue strict contraception up to 120 days after the last dose of IMP or pembrolizumab, whichever is the later.
- For the purposes of this study, women of childbearing potential are defined as "fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy."
- Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In female patients who are not using hormonal contraception or hormonal replacement therapy but with suspected menopause and less than 12 months of amenorrhea, a high follicle stimulating hormone (FSH) level in the postmenopausal range will be required at Screening to confirm a postmenopausal state. Confirmation with more than one FSH measurement is required.
- Highly effective contraception is defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly.
- Female patients of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Randomisation before dosing.
- Male patients with female partners of childbearing potential must be willing to use a condom and require their partner to use an a highly effective contraceptive method.
- Male patients must refrain from donating sperm, and female patients must refrain from donating eggs, from Baseline until 120 days after the last dose of IMP or pembrolizumab, whichever is the later.
Who cannot join
- Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed.
- Anti-cancer mAb treatment within 4 weeks prior to study Day 1.
- Chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 (radiation therapy can be allowed for palliative therapy of bone metastasis only).
- Not recovered from AEs Grade 2 or greater (except for alopecia) due to previously administered agents.
- Treatment with any investigational agent within 12 weeks of Screening Visit or 5 half-lives of the IMP (if known), whichever is longer, or current enrolment in an interventional clinical study.
- Prior treatment with setanaxib or participation in a previous setanaxib clinical study.
Show all 34Show fewer
- Prior treatment with pembrolizumab.
- Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer that has undergone potentially curative therapy, or malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IMP and of low potential risk for recurrence.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Active autoimmune disease requiring systemic treatment within the past 3 months or documented history of clinically severe autoimmune disease, or syndrome that requires systemic steroids or immunosuppressive agents. The following are exceptions to this criterion:
- Patients with vitiligo or alopecia.
- Any chronic skin condition that does not require systemic therapy.
- Patients with coeliac disease controlled by diet alone.
- Any evidence of current interstitial lung disease or pneumonitis, or a prior history of interstitial lung disease or non-infectious pneumonitis requiring high-dose glucocorticoids.
- Active infection requiring systemic therapy.
- Known human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or C infection. Patients with a past or resolved hepatitis B virus infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of hepatitis B surface antigen [HBsAg]) are eligible provided the hepatitis virus DNA test is negative. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction (PCR) is negative for hepatitis C virus RNA. Patients with ongoing anti-viral therapy with potent inhibitors of cytochrome P450 (CYP) 3A4 are not eligible. Testing for HIV is only required if clinically indicated and is not mandatory for this study.
- Serious chronic gastrointestinal conditions associated with diarrhoea.
- History of significant haematological problems, such as blood dyscrasias requiring treatment, aplastic anaemia, myelodysplastic syndrome, or leukaemia.
- Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the investigator).
- A positive pregnancy test or breastfeeding for female patients.
- Evidence of any of the following cardiac conduction abnormalities: a QTc Fredericia interval >450 milliseconds for male patients or >470 milliseconds for female patients. Patients with a second- or third-degree atrioventricular block are to be excluded.
- TSH >ULN at Screening.
- Unstable cardiovascular disease as defined by any of the following:
- Unstable angina within 6 months prior to Screening
- Myocardial infarction, coronary artery bypass graft surgery, or coronary angioplasty within 6 months prior to Screening
- Cerebrovascular accident within 6 months prior to Screening
- New York Heart Association Class III or IV heart failure
- Presence of any laboratory abnormality or condition that, in the opinion of the investigator, could interfere with or compromise a patient's treatment, assessment, or compliance with the protocol and/or study procedures.
- Any other condition that, in the opinion of the investigator, constitutes a risk or contraindication for the participation of the patient in the study, or that could interfere with the study objectives, conduct, or evaluation.
- Use of medications known to be potent CYP3A4 inhibitors or inducers, or potent uridine diphosphate (UDP)-glucuronosyltransferase 1A9 (UGT1A9) inhibitors or inducers, within 21 days prior to IMP administration.
- Legal incapacity or limited legal capacity.
- Psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- Patients who are unable to provide informed consent, are incarcerated or unable to follow protocol requirements.
- Previous randomisation in this study.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
France8 sites
Centre Hospitalier Universitaire Amiens-Picardie - Site Sud
Amiens, Picardie, 80054
Ramsay Health Clinic Belharra
Bayonne, 64100
Hôpital Saint-André
Bordeaux, 33000
Centre de Lutte contre le Cancer - Centre Oscar Lambret
Lille, Hauts-de-France, 59000
Centre Léon Bérard
Lyon, 69008
Hôpital de la Timone
Marseille, 13005
Institut Régional du Cancer de Montpellier
Montpellier, 34298
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Grand Est, 54519
United States5 sites
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, 63376
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
Siteman Cancer Center - North County
Florissant, Missouri, 63031
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Washington University School of Medicine Center for Advanced Medicine
St Louis, Missouri, 63110
Spain4 sites
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitario La Paz
Madrid, 28046
Complejo Hospitalario de Navarra
Pamplona, 31008
Hospital Universitario Virgen del Rocío
Seville, 41013
Italy2 sites
Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario
Milan, Milan, 20142
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Poland2 sites
Centrum Onkologii Im. Prof. F. Łukaszczyka w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-792
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie-Państwowy Instytut Badawczy O. w Gliwicach
Gliwice, Silesian Voivodeship, 44-102
United Kingdom2 sites
The Royal Marsden Hospital - London
London, England, SW3 6JJ
The Royal Marsden Hospital Head and Neck Unit
Sutton, England, SM5 5PT
About this study
Official title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN
The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Setanaxib, Pembrolizumab, Placebo
- Keywords
- Squamous Cell Carcinoma of Head and Neck, Setanaxib, Pembrolizumab, SCCHN, Keytruda
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SetanaxibDrug
Oral tablets, 400 mg per tablet
PembrolizumabBiological
Also called Keytruda
200 mg IV infusion
PlaceboDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Setanaxib 1600 mg and Pembrolizumab 200 mg | Experimental | Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks. Receives: Drug: Setanaxib; Biological: Pembrolizumab |
| Placebo and Pembrolizumab 200 mg | Active comparator | Participants will be administered placebo for the up to 24-month double-blind treatment period.
Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks. Receives: Biological: Pembrolizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Percentage Change in Tumour Size
Defined as the best percentage change from Baseline in the sum of diameters of target lesions, as assessed by RECIST v1.1.
Measured: Baseline to at least 15 weeks and up to 51 weeks
Secondary outcomes (20)
Progression Free Survival (PFS)
Defined as time from randomisation to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Measured: Baseline up to approximately 21 months
Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue
Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups.
Measured: Baseline up to approximately 9 weeks
Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue
Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups.
Measured: Baseline up to approximately 9 weeks
Change From Baseline in the Number of Regulatory T-cells in Tumour Tissue
Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups.
Measured: Baseline up to approximately 9 weeks
Overall Response Rate (ORR)
Proportion of the patients who have a complete response (CR) or partial response (PR) per RECIST v1.1 will be used to access ORR.
Measured: Baseline up to approximately 12 months
Duration of Response (DoR)
The minimum time when CR or PR is first observed to the time of progression of disease (PD) or death will be used to access DoR.
Measured: Baseline up to approximately 12 months
Disease Control Rate (DCR)
Proportion of the patients in whom the best overall response is determined as CR, PR, or stable disease (SD) per RECIST v1.1 will be used to access DCR.
Measured: Baseline up to approximately 12 months
Overall Survival (OS)
Defined as the time from randomisation to death due to any cause. Patients without documented death at the time of the final analysis will be censored at the date of the last follow-up.
Measured: Baseline up to 12 months
Number of Participants With Adverse Events (AEs)
Any clinically significant abnormalities in vital signs, physical examination, clinical laboratory tests (including biochemistry, hematology, urinalysis, and thyroid function), or 12- lead electrocardiogram (ECG) results will be recorded as Adverse Events (AEs).
Measured: Baseline up to approximately 21 months
Number of Participants With Adverse Events of Special Interest (AESI)
AESI include Anaemia and Hypothyroidism.
Measured: Baseline up to approximately 21 months
Levels of Programmed Death-ligand 1 (PD-L1) Expression in Tumour Tissue
Combined Positive Score (CPS) is a scoring method that predicts response to pembrolizumab in patients with cancer defined as the number of PD-L1-staining cells (tumor cells, lymphocytes, and macrophages) relative to the total number of viable tumor cells. A higher CPS score indicates an increased likelihood to respond to pembrolizumab treatment. It was hypothesized based on the mode of action of setanaxib that there would be an increased immunological response and therefore an increase in PD-L1 in tumor tissue.
Changes within treatment groups (ie, across paired tissue samples) and between treatment groups summarized both descriptively and as adjusted mean difference between treatment groups.
Measured: Baseline up to approximately 9 weeks
Change From Baseline in CAFs Cell Type Abundance Based on Gene Expression Profiles
Digital cytometry was carried out using CIBERSORTx. This estimates cell type abundance based on gene expression profiles in bulk RNA-Seq data. The abundance of myofibroblastic CAF were enumerated using a custom signature matrix based on gene expression profiles derived from annotated SCCHN scRNA-Seq data.
CIBERSORTx Absolute Abundance ratio is calculated by the median expression level of all genes in the signature matrix divided by the median expression level of all genes in the mixture (bulk RNA-Seq data for the sample). This produces a score that quantitatively measures the overall abundance of each cell type using gene expression profiles.
Measured: Baseline up to approximately 9 weeks
Change From Baseline in CD8+ TILs Cell Type Abundance Based on Gene Expression Profiles
Digital cytometry was carried out using CIBERSORTx. This estimates cell type abundance based on gene expression profiles in bulk RNA-Seq data. The abundance of tumor-infiltrating lymphocytes (TILs) were enumerated using a custom signature matrix based on gene expression profiles derived from annotated SCCHN scRNA-Seq data.
CIBERSORTx Absolute Abundance ratio is calculated by the median expression level of all genes in the signature matrix divided by the median expression level of all genes in the mixture (bulk RNA-Seq data for the sample). This produces a score that quantitatively measures the overall abundance of each cell type using gene expression profiles.
Measured: Baseline up to approximately 9 weeks
Change From Baseline in Regulatory T-cell Abundance Based on Gene Expression Profiles
Digital cytometry was carried out using CIBERSORTx. This estimates cell type abundance based on gene expression profiles in bulk RNA-Seq data. The abundance of regulatory T-cells were enumerated using a custom signature matrix based on gene expression profiles derived from annotated SCCHN scRNA-Seq data.
CIBERSORTx Absolute Abundance ratio is calculated by the median expression level of all genes in the signature matrix divided by the median expression level of all genes in the mixture (bulk RNA-Seq data for the sample). This produces a score that quantitatively measures the overall abundance of each cell type using gene expression profiles.
Measured: Baseline up to approximately 9 weeks
Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC[0-24]-ss) of Setanaxib
Measured: Baseline, Week 3, week 9, week 24, week 51
Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC24-ss) of GKT138184
Measured: Baseline, Week 3, week 9, week 24, week 51
Minimum Plasma Concentration at Steady State (Cmax-ss) of Setanaxib
Measured: Baseline, Week 3, week 9, week 24, week 51
Minimum Plasma Concentration at Steady State (Cmin-ss) of GKT138184
Measured: Baseline, Week 3, week 9, week 24, week 51
Maximum Plasma Concentration at Steady State (Cmax-ss) of Setanaxib
Measured: Baseline, Week 3, week 9, week 24, week 51
Maximum Plasma Concentration at Steady State (Cmax-ss) of GKT138184
Measured: Baseline up to approximately 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start6 Apr 2022
- Primary completion18 Feb 2024
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calliditas Therapeutics Suisse SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323656
- Sponsor's protocol ID
- GSN000400
- Status last verified
- Aug 2025
- First submitted
- 5 Apr 2022
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN
- ClinicalTrials.gov ID
- NCT05323656
- Acronym / sponsor ID
- GSN000400
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Squamous Cell Carcinoma of Head and Neck, Setanaxib, Pembrolizumab, SCCHN, Keytruda
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Calliditas Therapeutics Suisse SAIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 18 Feb 2024 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Setanaxib 1600 mg and Pembrolizumab 200 mg | Experimental | Drug: Setanaxib, Biological: PembrolizumabParticipants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period. Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks. |
| Placebo and Pembrolizumab 200 mg | Active comparator | Biological: Pembrolizumab, Drug: PlaceboParticipants will be administered placebo for the up to 24-month double-blind treatment period. Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male or female patients aged ≥18 years, inclusive, at the time of informed consent.
- Willing and able to give informed consent and to comply with the requirements of the study.
- Histologically- or cytologically-confirmed diagnosis of SCCHN that is recurrent or metastatic with or without nodal involvement, and with or without metastatic spread, and is not eligible for surgical resection.
- Candidates for first-line treatment for pembrolizumab for recurrent or metastatic SCCHN, at the discretion of the investigator.
- A positive CAFs level (defined as CAFs level in tumours ≥5%), performed at a central laboratory, with fresh tumour biopsy taken during or within 30 days prior to the Screening Period. If available, suitable archival tissue (taken within 6 months prior to the Screening Visit and where the patient has received no further anti-cancer therapy during this 6-month period) can be used to assess tumour CAFs level and determine patient eligibility.
Key exclusion criteria (34 listed)
- Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids as premedication for hypersensitivity reactions due to radiographic contrast agents are allowed.
- Anti-cancer mAb treatment within 4 weeks prior to study Day 1.
- Chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 (radiation therapy can be allowed for palliative therapy of bone metastasis only).
- Not recovered from AEs Grade 2 or greater (except for alopecia) due to previously administered agents.
- Treatment with any investigational agent within 12 weeks of Screening Visit or 5 half-lives of the IMP (if known), whichever is longer, or current enrolment in an interventional clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SetanaxibOral tablets, 400 mg per tablet | Drug | Setanaxib 1600 mg and Pembrolizumab 200 mg |
| PembrolizumabAlso: Keytruda200 mg IV infusion | Biological | Placebo and Pembrolizumab 200 mg, Setanaxib 1600 mg and Pembrolizumab 200 mg |
| PlaceboOral tablets | Drug | Placebo and Pembrolizumab 200 mg |
Primary outcome
Best Percentage Change in Tumour Size
Time frame: Baseline to at least 15 weeks and up to 51 weeks
Defined as the best percentage change from Baseline in the sum of diameters of target lesions, as assessed by RECIST v1.1.
20 secondary outcomes
Progression Free Survival (PFS)
Time frame: Baseline up to approximately 21 months
Change From Baseline in Cancer-associated Fibroblasts (CAFs) Level in Tumour Tissue
Time frame: Baseline up to approximately 9 weeks
Change From Baseline in the Number of Cluster of Differentiation 8 (CD8+) Tumour Infiltrating Lymphocytes (TILs) in Tumour Tissue
Time frame: Baseline up to approximately 9 weeks
Change From Baseline in the Number of Regulatory T-cells in Tumour Tissue
Time frame: Baseline up to approximately 9 weeks
Overall Response Rate (ORR)
Time frame: Baseline up to approximately 12 months
Duration of Response (DoR)
Time frame: Baseline up to approximately 12 months
Disease Control Rate (DCR)
Time frame: Baseline up to approximately 12 months
Overall Survival (OS)
Time frame: Baseline up to 12 months
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to approximately 21 months
Number of Participants With Adverse Events of Special Interest (AESI)
Time frame: Baseline up to approximately 21 months
Levels of Programmed Death-ligand 1 (PD-L1) Expression in Tumour Tissue
Time frame: Baseline up to approximately 9 weeks
Change From Baseline in CAFs Cell Type Abundance Based on Gene Expression Profiles
Time frame: Baseline up to approximately 9 weeks
Change From Baseline in CD8+ TILs Cell Type Abundance Based on Gene Expression Profiles
Time frame: Baseline up to approximately 9 weeks
Change From Baseline in Regulatory T-cell Abundance Based on Gene Expression Profiles
Time frame: Baseline up to approximately 9 weeks
Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC[0-24]-ss) of Setanaxib
Time frame: Baseline, Week 3, week 9, week 24, week 51
Area Under The Concentration-time Curve Over a 24-hour Period at Steady State (AUC24-ss) of GKT138184
Time frame: Baseline, Week 3, week 9, week 24, week 51
Minimum Plasma Concentration at Steady State (Cmax-ss) of Setanaxib
Time frame: Baseline, Week 3, week 9, week 24, week 51
Minimum Plasma Concentration at Steady State (Cmin-ss) of GKT138184
Time frame: Baseline, Week 3, week 9, week 24, week 51
Maximum Plasma Concentration at Steady State (Cmax-ss) of Setanaxib
Time frame: Baseline, Week 3, week 9, week 24, week 51
Maximum Plasma Concentration at Steady State (Cmax-ss) of GKT138184
Time frame: Baseline up to approximately 26 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Squamous Cell Carcinoma of Head and Neck
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Setanaxib and Pembrolizumab in people with Squamous Cell Carcinoma of Head and Neck, run by Calliditas Therapeutics Suisse SA at 24 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, United States, Spain, Italy, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Percentage Change in Tumour Size (time frame: Baseline to at least 15 weeks and up to 51 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.