PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
A Randomized, Open-label, Two-arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy in Patients With Recurrent or Metastatic Cervical Cancer.
Precigen, Inc
46 participants
Mar 21, 2025
INTERVENTIONAL
Conditions
Summary
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 Criteria11
- 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 Criteria8
- 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.
Interventions
Subjects randomized will receive PRGN-2009 (5 x 10\^11 PU, subcutaneous (SC) injection) every 3 weeks for three administrations, thereafter subjects will continue to receive PRGN-2009 administrations every 6 weeks. Pembrolizumab will be administered concurrently as intravenous (IV) infusion (400 mg) every 6 weeks.
Subjects randomized will receive IV infusion of pembrolizumab (400 mg) administered every 6 weeks.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06157151