Actively Recruiting
PRGN-2009 in Combination With Pembrolizumab in Patients With 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
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.
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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