LENTI-HPV-07-CT01: An Open-Label Phase 1-2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants with HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer

Inclusion:    

Arm A: Refractory recurrent or metastatic cervical cancer that is not amenable to therapy with curative intent (ie, surgery or radiation therapy with or without chemotherapy). Participants must have received prior treatment in the metastatic or unresectable locally advanced setting including, at least one platinum-containing chemotherapy. Participants with tumors expressing PD-L1 (CPS≥1) determined by an FDA approved test, must have also received pembrolizumab with chemotherapy, with or without bevacizumab. Participants that have not received all these treatments may be included at the discretion of the Investigator upon review with the Medical Monitor.

-p16 positive by IHC locally

-Accessible lesion for mandatory biopsy and must be agreeable to research biopsy.  Pts should have additional non-biopsied target lesions evaluable by RECIST 1.1

-No infections requiring systemic tx within 7 days prior to dosing