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.
Patients will receive up to 11 intramuscular (i.m.) vaccinations of VB10.16, for up to 48 weeks from first vaccination. Patients will receive 5 vaccinations of 3 mg VB10.16 during the first 12 weeks, followed by vaccination every 6 weeks for up to 48 weeks from first immunisation (total of 11 vaccinations). Patients will receive up to 17 infusions of atezolizumab for up to 48 weeks from first treatment. Atezolizumab (1200 mg) will be administered as an intravenous (i.v.) infusion every 3 weeks. A follow-up period of up to 12 months will follow the 48 week treatment period. Response to the VB10.16 and atezolizumab combination will be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) at every 9 weeks throughout the treatment period according to the RECIST 1.1 criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Vaccination
Intravenously infusion
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Hopital de Libramont
Incidence and severity of adverse events (AEs)
The number and percentage of participants that experience an adverse event (AE
Time frame: 48 weeks (1 year follow-up)
Overall response rate (ORR) using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at any time during the study
ORR as assessed by RECIST v1.1
Time frame: 48 weeks (1 year follow-up)
Duration of response (DOR)
Estimate the duration of response (DOR) in patients with advanced cervical cancer
Time frame: 48 weeks (1 year follow-up)
Progression-free survival (PFS)
Estimate the Progression-free survival (PFS) in patients with advanced cervical cancer
Time frame: 48 weeks (1 year follow-up)
Overall survival (OS)
Overall survival (OS) in patients with advanced cervical cancer
Time frame: 48 weeks (1 year follow-up)
Evaluate immunogenicity of VB10.16 in combination with atezolizumab by analysing HPV16 E6/E7-specific cellular immune responses
Systemic T-cell response
Time frame: 48 weeks (1 year follow-up)
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