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PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
Sponsor: Precigen, Inc
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2025-03-21
Completion Date
2028-01-30
Last Updated
2025-11-14
Healthy Volunteers
No
Conditions
Interventions
PRGN-2009 plus Pembrolizumab
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.
Pembrolizumab alone
Subjects randomized will receive IV infusion of pembrolizumab (400 mg) administered every 6 weeks.
Locations (3)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
National Institute of Health
Bethesda, Maryland, United States
University of Washington
Seattle, Washington, United States