Safety and Efficacy of VB10.16 and Pembrolizumab in patients with Head-Neck Squamous Cell Carcinoma
- Conditions
- nresectable recurrent or metastatic HPV16 (Human Papilloma Virus) positive oropharyngeal Head and Neck Squamous Cell CarcinomaMedDRA version: 21.0Level: PTClassification code: 10060121Term: Squamous cell carcinoma of head and neck Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-503055-26-00
- Lead Sponsor
- ykode Therapeutics ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 51
=18 years of age (or as per national legal age of trial consent, whichever is higher) at date of signing the informed consent form (ICF)., Platelets =100 × 109 /L (100,000/µL)., Neutrophils (absolute neutrophil count [ANC]) =1.5 × 109 /L (1,500/µL)., Patients capable of giving informed consent must provide signed and dated written informed consent prior to initiation of any study-related procedures, Hemoglobin =5.6 mmol/L (9.0 g/dL, Bilirubin (BILI), total =1.5 × upper limit of normal (ULN) (except Gilbert syndrome, then direct BILI =2 × ULN) or direct bilirubin =ULN for participants with total bilirubin levels >1.5 × ULN, Aspartate transaminase (AST) =2.5 × ULN or =5 × ULN for a patient with liver metastases., Alanine transaminase (ALT) =2.5 × ULN or = 5 × ULN for a patient with liver metastases., Alkaline phosphatase =2.5 × ULN or =5 × ULN for a patient with liver metastases., International normalized ratio (INR) or prothrombin time (PT) = 1.5 x ULN unless the patient is receiving anticoagulant therapy, in which case PT and partial thromboplastin time (PTT)/activated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants., Estimated glomerular filtration rate (eGFR) =45 mL/min/1.73 m2 using the Cockroft-Gault formula., Female patients of childbearing potential: negative serum pregnancy test (=72 hours)., Female patients of childbearing potential must agree to use highly effective contraception throughout the trial (14 days prior to initiation of treatment for oral contraception), and for at least 120 days (according to the current version of the investigator’s brochure for pembrolizumab) after the last dose of pembrolizumab and up to 6 months after the last dose of VB10.16, whichever comes last. Male patients must agree to use male condoms during intercourse throughout the trial, and up to 3 months after the last dose of VB10.16, and must refrain from sperm donation in the same period. Highly effective forms of contraception include: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; or sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial drugs). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (calendar, symptothermal, post ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception., Histologically or cytologically confirmed R/M HNSCC,located in the oropharynx, considered incurable by local therapy and eligible for monotherapy with pembrolizumab., HPV16 positivity of R/M oropharyngeal HNSCC confirmed by designated central laboratory., PD-L1 positivity (CPS =1) using the validated PD-L1 IHC 22C3 pharmDx (DAKO) assay., Primary tumor location in the oropharynx., At least 1 measurable lesion per RECIST 1.1., Eastern Cooperative Oncology Group (ECOG) performance status (PS) =1
Has disease that is suitable for local therapy with curative intent., Prior therapy with a monoclonal or bispecific antibody or antibody fragment (or other molecule with similar mechanism of action) that engages T-cells., Has received a live or live-attenuated vaccine within 30 days prior to the first dose of trial intervention, Administration of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine within 30 days prior to VB10.16 treatment start., Prior administration with a therapeutic HPV16 vaccine., Patients receiving systemic immunosuppression with immunosuppressive agents such as cyclosporine, azathioprine, methotrexate, or tumor necrosis factor alpha (TNF a) blockers for any concurrent condition., Chronic administration of systemic corticosteroids: prednisone >10 mg daily (or dose equivalent)., Administration of G-CSF/GM-CSF or transfusions with red blood cells, platelets, or plasma components =2 weeks prior to VB10.16 treatment start., Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)., Has received prior surgery within 4 weeks prior to treatment., Any planned major surgery., Has progressive disease =6 months after completion of curatively intended concurrent chemoradiotherapy for locoregionally advanced R/M oropharyngeal HNSCC., Past or current malignancy other than inclusion diagnosis, except for: Malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for at least 3 years before screening and felt to be at low risk for recurrence by the treating physician. Adequately treated breast ductal carcinoma in situ without evidence of disease. Adequately treated cervical carcinoma in situ, without evidence of disease. Adequately treated non-melanoma skin cancer without evidence of disease. Adequately treated superficial or in situ carcinoma of the bladder without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer.., Any current bleeding disorder, active bleeding, or bleeding diathesis., Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia., History of myocardial infarction =6 months prior to planned VB10.16 treatment start., Uncontrolled hypertension (systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg), despite optimal medical management., Any other significant cardiac disease(s) that, in the opinion of the investigator, is/are clinically significant and/or unacceptable., Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease., Primary immunodeficiency, other immunosuppressive disorder, and/or other causes of immunosuppression., Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed., Has a known history of human immunodeficiency virus (HIV) infection., Primary tumor site of the oral cavity, hypopharynx, larynx or nasopharynx (any
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method