GOG-3091/VB-C-04 Nykode Cervical
This is a multi-center study in patients with recurrent or metastatic HPV16-positive, PD-L1 positive cervical cancer who has progressed during or after treatment with the first-line standard of care (pembrolizumab with chemotherapy with/without bevacizumab).
The trial is designed to investigate VB10.16 alone or in combination with the immune checkpoint inhibitor, atezolizumab.
The trial consist of 2 parts: the first part which investigates VB10.16 + placebo versus VB10.16 + atezolizumab. Approximately 30 patients will be included in each group. The goal of this part is to evaluate which of the two treatments is the best.
The second part of the study will select the best treatment from part 1 and investigate the safety and efficacy of additional 70 patients.