Actively Recruiting
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
Led by Precigen, Inc · Updated on 2026-04-23
24
Participants Needed
3
Research Sites
211 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 with recurrent or metastatic cervical cancer who have not responded to pembrolizumab alone. This Phase 2 study focuses on patients with pembrolizumab-resistant cervical cancer confirmed by tissue tests and positive for HPV. The study aims to better understand how this combination treatment affects tumor response and overall patient outcomes. Participants will receive PRGN-2009 through a subcutaneous injection at a dose of 5 x 10^11 PU every three weeks for the first three doses, then every six weeks thereafter. Pembrolizumab will be given intravenously at 400 mg every six weeks alongside PRGN-2009. This treatment schedule continues throughout the study period, with no placebo group, to assess the combined therapy's impact on cervical cancer. Throughout the study, participants will undergo regular evaluations including scans to measure tumor size according to RECIST v1.1 criteria, laboratory tests to monitor organ function, and assessments of overall health and side effects. Researchers will track the objective response rate, progression-free survival, and overall survival over one year. Additional monitoring includes checking for vector shedding after PRGN-2009 administration up to four months. The total study duration extends until November 2030, ensuring thorough safety and effectiveness data collection.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed recurrent or metastatic cervical cancer
- Prior treatment with pembrolizumab (monotherapy or combination) for at least 6 weeks
- Histologically or cytologically confirmed HPV positive disease
- Measurable disease by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks from enrollment
- Adequate organ function
- Negative serum pregnancy test; women of child-bearing potential must agree to use contraception before and for at least 6 months after study treatment
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Prior chemotherapy or targeted therapy within 14 days before study entry
- Monoclonal antibody treatment within 4 weeks before study entry
- Unresolved adverse events from prior treatments
- Immunodeficiency, active autoimmune disease on immunosuppression, or immunosuppressive therapy within 7 days
- Active hepatitis B or C infection within 30 days before enrollment
- History of non-infectious pneumonitis or interstitial lung disease
- History of endocrine autoimmune disease (except treated Graves' disease or hypothyroidism on replacement)
- Live vaccine within 30 days before first dose
- Other active malignancy within 1 year before study entry
- Known central nervous system disease
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its excipients
- Active tuberculosis infection
- Pregnant or lactating women
- History of solid organ transplant
- Participation in another investigational agent or device study within 4 weeks before first dose
- Inability to comply with study monitoring requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive PRGN-2009 by subcutaneous injection every 3 weeks for three doses, then every 6 weeks, combined with pembrolizumab intravenous infusion every 6 weeks.
Visits every 3 weeks for first 3 doses, then every 6 weeks thereafter
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
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