GOG-3091: A Two-Arm Randomized, Double-Blind, Placebo-Controlled Phase 2 Selection Trial to Evaluate the Efficacy and Safety of VB10.16 Alone or in Combination with Atezolizumab in Patients with HPV16-Positive, PD-L1-positive, Recurrent or Metastatic Cerv

Human Clinical Trial - Confidential. A Two-Arm Randomized, Double-Blind, Placebo-Controlled Phase 2 Selection Trial to Evaluate the Efficacy and Safety of VB10.16 Alone or in Combination with Atezolizumab in Patients with HPV16-Positive, PD-L1-positive, Recurrent or Metastatic Cervical Cancer who are Refractory to Pembrolizumab with Chemotherapy with/without Bevacizumab. The purpose of this trial is to compare the efficacy and safety of VB10.16 alone or in combination with atezolizumab in HPV16-positive and PD-L1-positive CC patients in the R/M setting who have received standard of care with pembrolizumab + platinumbased chemotherapy +/- bevacizumab in a systemic first-line treatment setting. VB10.16 is a DNA-based therapeutic immunotherapy vaccine developed to treat HPV16- associated premalignant and malignant lesions. Final safety and efficacy data from previously treated participants with non-resectable, recurrent, or metastatic HPV16-positive CC suggest a positive benefit-risk profile and provide a rationale to continue evaluating the treatment potential in this patient group in which there is a high unmet medical need.