Advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care MedDRA version: 21.1 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864
Conditions
Sponsors
Nykode Therapeutics ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has persistent, recurrent, or metastatic non-resectable squamous cell carcinoma, adeno-squamous carcinoma, or adenocarcinoma of the cervix, who has failed or is not eligible for treatment with systemic chemotherapy, radiotherapy or other standard-of-care anticancer treatment. 2. Tumour must be HPV16 positive = as determined by central laboratory. Provision of an archival tumour tissue sample not older than 2 years or new biopsy for analysing HPV16 status is mandatory. 3. Must have a biopsy (archived or new) available for PD-L1 assessment at Screening. Provision of an archival tumour tissue sample not older than 2 years or new biopsy for analysing PD-L1 status is mandatory. 4. Has measurable disease as assessed by the local site investigator/radiology as per RECIST 1.1. 5. Has recovered from the effects of surgery, radiation therapy, or chemoradiotherapy. At least 6 weeks must have elapsed from the last administration of chemoradiotherapy to Visit 1, and at least 3 weeks must have elapsed from the last administration of radiation therapy alone, and at least 4 weeks must have elapsed from the last dose of prior systemic anti-cancer therapy and from the time of any major surgical procedure before Visit 1. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at Screening. 7. Is aged 18 years or older. 8. Has life expectancy of at least 6 months in the best judgement of the investigator. 9. Is willing and able to sign a written informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Patients with rapidly progressing disease who have experienced disease progression while on anticancer treatment (or within 3 months from the last dose of this treatment). 2. Has brain metastases (unless they have received prior treatment and are controlled and stable for at least 6 weeks before Visit 1) or leptomeningeal spread of disease. 3. Has positive serological test for: -hepatitis C virus (HCV) and has not been treated; patients who are HCV-RNA negative would be eligible. - hepatitis B virus (HBV) surface antigen (HBsAg); patients with positive HBV core antibody must have positive surface antibody and negative HBV viral load (HBV DNA) to be eligible. - human immunodeficiency virus (HIV). 4. Has other concomitant or prior malignant disease, except for: a) adequately treated basal cell carcinoma or other non-melanomatous skin cancer, or low-grade urothelial cancer; b) other malignancies treated with curative intent, without disease recurrence and in complete remission with treatment completed 2 years or more before Screening study entry (time of providing consent). 5. Has an active, known or suspected autoimmune disease including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, vasculitis, glomerulonephritis and multiple sclerosis. Exceptions include: patients with vitiligo; autoimmune-related hypothyroidism on stable dose of hormone replacement; type 1 diabetes; mellitus on an insuline regime; alopecia areata; psoriasis; eczema; and transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent (e.g., acute Lyme arthritis). Exceptions require discussion with the medical monitor). 6. Is receiving systemic immunosuppression including systemic steroids or the use of immunosuppressive agents (e.g., cyclosporine, azathioprine, methotrexate or tumour necrosis factor alfa [TNF-a ] blockers) for any concurrent condition. All systemically administered corticosteroids must be discontinued >2 weeks prior to the first study vaccine administration. 7. Has known allergy to aminoglycosides (especially kanamycin) or any study treatment component. 8. Has history of toxic shock syndrome. Please refer to section 8.2 of the protocol for the full criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety/tolerability and clinical efficacy by overall response rate (ORR) of multiple doses of 3 mg VB10.16 immunotherapy in combination with atezolizumab;Secondary Objective: -To assess the immunogenicity of multiple doses of 3 mg VB10.16 immunotherapy in combination with 1200 mg atezolizumab - To further assess efficacy of multiple doses of 3 mg VB10.16 immunotherapy in combination with 1200 mg atezolizumab in patients by PFS, duration of response (DOR), and OS;Primary end point(s): - Incidence and severity of adverse events (AEs) -Overall response rate (ORR) defined as the proportion of patients in the analysis population who have complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at any time during the study;Timepoint(s) of evaluation of this end point: There will be continuous safety assessments (AEs) at screening and throughout the study according to the schedule of events. Tumour imaging by CT/MRI will occur at baseline, W9, W18, W27, W36 and W45 during the 48 weeks treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Evaluate immunogenicity of VB10.16 in combination with atezolizumab by analysing HPV16 E6/E7-specific cellular immune responses during therapy - Duration of response (DOR), defined as time from first RECIST 1.1 response (CR/PR) to the first date that disease progression is objectively documented or death from any cause - Progression-free survival (PFS), defined as the time from first study treatment to the first documented disease progression according to RECIST 1.1 or death due to any cause, whichever occurs first - Overall survival (OS) defined as time from first study treatment until death/EoS;Timepoint(s) of evaluation of this end point: Tumour imaging by CT/MRI will occur at baseline, W9, W18, W27, W36 and W45 during the 48 weeks treatment period. | — |
Countries
Belgium, Bulgaria, Czechia, Czech Republic, Germany, Norway, Poland
Contacts
Public ContactProject Management
Premier Research
Outcome results
None listed