This phase IIa study is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. Tumour must be HPV16 positive. Provision of an archival tumour tissue sample not older than 2 years or new biopsy for analysing HPV16 status is mandatory.
✓. Must have a biopsy (archived or new) available for PD L1 assessment at Screening.
✓. Has measurable disease as assessed by the local site investigator/radiology as per RECIST 1.1.
✓. Has recovered from the effects of surgery, radiation therapy, or chemoradiotherapy.
✓. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at Screening.
✓. Is aged 18 years or older.
✓. Has life expectancy of at least 6 months in the best judgement of the investigator.
Exclusion criteria
✕. Patients who, in the investigator's opinion, have progressed rapidly on their previous anticancer treatment (e.g., did not achieve any response \[CR, PR, or SD\]).
✕. Has brain metastases (unless they have received prior treatment and are controlled and stable for at least 6 weeks before study enrolment) or leptomeningeal spread of disease.
✕
What they're measuring
1
Incidence and severity of adverse events (AEs)
Timeframe: 48 weeks (1 year follow-up)
2
Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at any time during the study
. Has positive serological test for hepatitis C virus (HCV), hepatitis B virus (HBV), surface antigen (HBsAg), positive HBV core antibody. Human immunodeficiency virus (HIV).
✕. Has other concomitant or prior malignant disease,
✕. Has an active, known or suspected autoimmune disease.
✕. Is receiving systemic immunosuppression including systemic steroids or the use of immunosuppressive agents for any concurrent condition.
✕. Has known allergy to aminoglycosides or kanamycin or any study treatment component.