RecruitingPhase 2NCT06157151

PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer

A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.


Sponsor

Precigen, Inc

Enrollment

24 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new vaccine-based immunotherapy called PRGN-2009 combined with pembrolizumab (an immune checkpoint drug) in women with cervical cancer that has come back or spread and is no longer responding to pembrolizumab alone. **You may be eligible if...** - You are 18 years or older - You have recurrent or metastatic cervical cancer confirmed by biopsy - Your cancer previously received pembrolizumab and stopped responding - You have received no more than two prior treatments in the recurrent or metastatic setting - Your tumor tests positive for PD-L1 and HPV16/18 - Your cancer can be measured on imaging - Your general health is good enough for treatment **You may NOT be eligible if...** - You have not previously been treated with pembrolizumab - Your cancer does not express PD-L1 or is HPV-negative - You have received more than two prior lines of treatment - You have serious health conditions that would make immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALPRGN-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.


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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06157151


Related Trials