This Phase 2 study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
Age 18 years and older.
Recurrent or metastatic cervical cancer (histologically or cytologically confirmed)
Must have been treated with pembrolizumab, either as monotherapy or in combination, for atleast 6 weeks.
Subjects must have histologically or cytologically confirmed HPV positive disease
Prior chemotherapy, targeted therapy within 14 days; monoclonal antibody within 4 weeks; unresolved AEs.
Immunodeficiency, active autoimmune disease on immunosuppression, or immunosuppressive therapy within 7 days. HIV eligible with disease control.
Active hepatitis B (HBsAg+) or hepatitis C (HCV RT-PCR+) within 30 days of enrollment.
History of non-infectious pneumonitis or interstitial lung disease.
Precigen, Inc
Lead sponsor
National Cancer Institute (NCI)
Collaborator