Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer

Prior treatment

• 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.
• Is receiving systemic immunosuppression including systemic steroids or the use of immunosuppressive agents for any concurrent condition.
• Has ongoing toxicity from prior therapy
• Has severe infections within 4 weeks prior to study start
• Has received investigational drug within 30 days before study entry.
• Has received vaccination against infections within 30 days before study entry.
• Has had prior treatment with CD137, anti-PD-1, or anti-PD-L1 therapeutic antibody or other immune checkpoint targeting agents.

Other illness

• 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.
• Has known allergy to aminoglycosides or kanamycin or any study treatment component.
• Has history of toxic shock syndrome.
• Has history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organising pneumonia, immune enteritis or active pneumonitis.
• Has evidence or history of clinically significant cardiac disease including congestive heart failure
• Has known hypersensitivity to any component of the atezolizumab or VB10.16 formulation.

Other

• Current participation in a clinical trial

• 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.
• Is willing and able to sign a written informed consent form.