A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Registration Number
- NCT05323656
- Lead Sponsor
- Calliditas Therapeutics Suisse SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria:<br><br> - Male or female patients aged =18 years, inclusive, at the time of informed consent.<br><br> - Willing and able to give informed consent and to comply with the requirements of the<br> study.<br><br> - Histologically- or cytologically-confirmed diagnosis of SCCHN that is recurrent or<br> metastatic with or without nodal involvement, and with or without metastatic spread,<br> and is not eligible for surgical resection.<br><br> - Candidates for first-line treatment for pembrolizumab for recurrent or metastatic<br> SCCHN, at the discretion of the investigator.<br><br> - A positive CAFs level (defined as CAFs level in tumours =5%), performed at a central<br> laboratory, with fresh tumour biopsy taken during or within 30 days prior to the<br> Screening Period. If available, suitable archival tissue (taken within 6 months<br> prior to the Screening Visit and where the patient has received no further<br> anti-cancer therapy during this 6-month period) can be used to assess tumour CAFs<br> level and determine patient eligibility.<br><br> - Measurable disease, in accordance with RECIST v1.1, and with tumour accessible and<br> of sufficient volume for pre-treatment and on-treatment biopsy.<br><br> - Combined positive score (CPS) =1, as determined on the archival or fresh tumour<br> biopsy taken during or within 30 days prior to the Screening Period.<br><br> - HPV status known at randomisation.<br><br> - Life expectancy of at least 6 months in the judgment of the investigator.<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.<br><br> - Adequate organ and bone marrow function within 35 days of starting study treatment.<br> Criteria a to c cannot be met in patients with ongoing or recent (within 14 days<br> of screening test) transfusions or who require ongoing growth factor support:<br><br> 1. Absolute neutrophil count =1,000/mm3 (= 1.0×109/L).<br><br> 2. Platelet count =100,000/mm3 (= 100×109/L).<br><br> 3. Haemoglobin =9 g/dL, in the absence of transfusions for at least 2 weeks.<br> Patients requiring ongoing transfusions or growth factor support to maintain<br> haemoglobin = 9g/dL are not eligible.<br><br> 4. Total bilirubin =1.5×upper limit of normal (ULN) (if associated with liver<br> metastases or Gilbert's disease, =3×ULN).<br><br> 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3×ULN.<br><br> 6. Serum creatinine =2.0 mg/dL or creatinine clearance =40 mL/min (measured or<br> calculated according to the method of Cockcroft and Gault).<br><br> - Female patients of childbearing potential must use a highly effective method of<br> contraception to prevent pregnancy for =4 weeks before randomisation and must agree<br> to continue strict contraception up to 120 days after the last dose of IMP or<br> pembrolizumab, whichever is the later.<br><br> 1. For the purposes of this study, women of childbearing potential are defined as<br> fertile, following menarche and until becoming postmenopausal unless<br> permanently sterile. Permanent sterilisation methods include hysterectomy,<br> bilateral salpingectomy and bilateral oophorectomy.<br><br> 2. Postmenopausal state is defined as no menses for 12 months without an<br> alternative medical cause. In female patients who are not using hormonal<br> contraception or hormonal replacement therapy but with suspected menopause and<br> less than 12 months of amenorrhea, a high follicle stimulating hormone (FSH)<br> level in the postmenopausal range will be required at Screening to confirm a<br> postmenopausal state. Confirmation with more than one FSH measurement is<br> required.<br><br> 3. Highly effective contraception is defined as methods that can achieve a failure<br> rate of less than 1% per year when used consistently and correctly.<br><br> - Female patients of childbearing potential must have a negative serum pregnancy test<br> at Screening and a negative urine pregnancy test at Baseline/Randomisation before<br> dosing.<br><br> - Male patients with female partners of childbearing potential must be willing to use<br> a condom and require their partner to use an a highly effective contraceptive<br> method.<br><br> - Male patients must refrain from donating sperm, and female patients must refrain<br> from donating eggs, from Baseline until 120 days after the last dose of IMP or<br> pembrolizumab, whichever is the later.<br><br>Exclusion Criteria:<br><br> - Diagnosis of immunosuppression or receiving systemic steroid therapy or any other<br> form of immunosuppressive therapy within 7 days prior to the first dose of study<br> treatment, with the exception of intranasal and inhaled corticosteroids or systemic<br> corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent.<br> Steroids as premedication for hypersensitivity reactions due to radiographic<br> contrast agents are allowed.<br><br> - Anti-cancer mAb treatment within 4 weeks prior to study Day 1.<br><br> - Chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks<br> prior to study Day 1 (radiation therapy can be allowed for palliative therapy of<br> bone metastasis only).<br><br> - Not recovered from AEs Grade 2 or greater (except for alopecia) due to previously<br> administered agents.<br><br> - Treatment with any investigational agent within 12 weeks of Screening Visit or 5<br> half-lives of the IMP (if known), whichever is longer, or current enrolment in an<br> interventional clinical study.<br><br> - Prior treatment with setanaxib or participation in a previous setanaxib clinical<br> study.<br><br> - Prior treatment with pembrolizumab.<br><br> - Known additional malignancy that is progressing or requires active treatment<br> excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in<br> situ cervical cancer that has undergone potentially curative therapy, or malignancy<br> treated with curative intent and with no known active disease =2 years before the<br> first dose of IMP and of low potential risk for recurrence.<br><br> - Known active central nervous system metastases and/or carcinomatous meningitis.<br><br> - Active autoimmune disease requiring systemic treatment within the past 3 months or<br> documented history of clinically severe autoimmune disease, or syndrome that<br> requires systemic steroids or immunosuppressive agents. The following are exceptions<br> to this criterion:<br><br> 1. Patients with vitiligo or alopecia.<br><br> 2. Any chronic skin condition that does not require systemic therapy.<br><br> 3. Patients with coeliac disease controlled by diet alone.<br><br> - Any evidence of current interstitial lung disease or pneumonitis, or a prior history<br> of interstitial lung disease or non-infectious pneumonitis requiring high-dose<br> glucocorticoids.<br><br> - Active infection requiring systemic therapy.<br><br> - Known human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B<br> or C infection. Patients with a past or resolved hepatitis B virus infection<br> (defined as the presence of hepatitis B core antibody [HBcAb] and absence of<br> hepatitis B surface antigen [HBsAg]) are eligible provided the hepatitis virus DNA<br> test is negative. Patients positive for hepatitis C antibody are eligible only if<br> polymerase chain reaction (PCR) is negative for hepatitis C virus RNA. Patients with<b
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best Percentage Change in Tumour Size
- Secondary Outcome Measures
Name Time Method