Phase 12a Study of Lenti-HPV-07 Vaccine for HPV-Related Cervical and Oropharyngeal Cancer Evaluating Safety, Immune Response, and Early Effectiveness

What this Trial Is About

Researchers are evaluating the safety and immune response of a new potential treatment called Lenti-HPV-07 for patients with cancers caused by Human Papilloma Virus HPV, specifically cervical or oropharyngeal cancers. The study aims to determine if the treatment is safe and whether it stimulates the immune system. Participants will be grouped based on their cancer type, either recurrentmetastatic or newly diagnosed locally advanced cancer. Participants in this trial will receive Lenti-HPV-07 through intramuscular injections. Those with recurrent or metastatic cancer receive two injections one month apart, while newly diagnosed participants receive one injection before starting standard treatments such as surgery, radiation, or chemotherapy. After treatment, participants will be followed for up to one year through clinic visits or phone calls to monitor their health. During the study, participants will undergo safety and immune response assessments, including monitoring side effects and immune markers for up to 12 months after the last injection. Researchers will also evaluate other factors such as PD-L1 expression. The total participation includes treatment administration followed by quarterly follow-up visits or calls for one year to gather data on safety, immune response, and preliminary treatment effects.

A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer