Overview

This randomized trial will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.

Eligibility

Inclusion Criteria:

• Age 18 years and older.
• Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant.
• Must have been treated with pembrolizumab, either as monotherapy or in combination
• Patients must have received no more than two prior systemic regimens in the recurrent or metastatic setting
• Tumors are confirmed positive for PD-L1 and HPV16/18
• Measurable disease that can be accurately measured by RECIST v1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks from the time of enrollment.
• Must have adequate organ function
• Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.
• All patients must have the ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

• Patients with presence of other active malignancy within 1 year prior to study entry
• Known Central Nervous System (CNS) disease
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Known history of active tuberculosis (TB, Bacillus tuberculosis).
• Pregnant and lactating women are excluded from this study.
• Patients with a history of solid organ transplant.
• Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.
• Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.