Actively Recruiting
Study of PRGN-2009 Combined With Pembrolizumab for Patients With Pembrolizumab-Resistant Recurrent or Metastatic Cervical Cancer
Led by Precigen, Inc · Updated on 2026-04-23
24
Participants Needed
3
Research Sites
263 weeks
Total Duration
On this page
Sponsors
P
Precigen, Inc
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of PRGN-2009 combined with pembrolizumab in patients who have recurrent or metastatic cervical cancer that is resistant to pembrolizumab treatment. This Phase 2 study focuses on women with this type of cancer related to HPV infection, aiming to measure how well the treatment can shrink or control the cancer over a one-year period. Participants will receive PRGN-2009 as a subcutaneous injection at a dose of 5 x 10^11 PU every 3 weeks for the first three doses, followed by injections every 6 weeks. Pembrolizumab will be given intravenously at 400 mg every 6 weeks alongside PRGN-2009. This combined treatment schedule will continue throughout the study. During the study, patients will be monitored for cancer response using RECIST v1.1 criteria, as well as for safety and side effects. Researchers will assess how the cancer responds to the study treatment and observe any adverse events. Participants must be at least 18 years old and able to provide informed consent, with regular evaluations to ensure ongoing eligibility and adherence to the treatment plan.
CONDITIONS
Official Title
PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Recurrent or metastatic cervical cancer confirmed by tissue or cytology
- Treated with pembrolizumab for at least 6 weeks
- HPV positive disease confirmed by tissue or cytology
- Measurable disease per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks from enrollment
- Adequate organ function
- Negative serum pregnancy test for women of child-bearing potential
- Women of child-bearing potential must agree to use contraception during and for 6 months after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior chemotherapy or targeted therapy within 14 days before study
- Monoclonal antibody therapy within 4 weeks before study
- Unresolved adverse events from prior treatments
- Immunodeficiency or active autoimmune disease requiring immunosuppression within 7 days
- Active hepatitis B or C within 30 days before enrollment
- History of non-infectious pneumonitis or interstitial lung disease
- History of endocrine autoimmune disease except treated Graves' or hypothyroidism on replacement
- Live vaccine within 30 days before first dose
- Other active malignancy within 1 year prior to study
- Known central nervous system disease
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its components
- Active tuberculosis history
- Pregnant or breastfeeding women
- History of solid organ transplant
- Participation in another investigational study or use of investigational device within 4 weeks before first dose
- Unable to comply with study monitoring requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
National Institute of Health
Bethesda, Maryland, United States, 20892
Actively Recruiting
3
University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
A
Amy Lankford
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here