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.
1 other identifier
interventional
24
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2025
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
December 5, 2023
CompletedStudy Start
First participant enrolled
November 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2030
April 23, 2026
April 1, 2026
1 year
November 27, 2023
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the Objective Response Rate (ORR) following treatment with PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
The ORR will be calculated as the combination of subjects achieving a complete response or a partial response per RECIST v1.1. ORR will be calculated and presented with 2-sided 95% confidence interval.
1 year
Secondary Outcomes (5)
Safety of PRGN-2009 in combination with pembrolizumab
1 year
Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab
1 year
Best Overall Responses (BOR) and Disease Control Rate (DCR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab
1 year
Time to Response and Duration of Responses following treatment with PRGN-2009 in combination with pembrolizumab
1 year
Vector shedding following subcutaneous administration of PRGN-2009
Up to 4 months
Study Arms (1)
PRGN-2009 plus Pembrolizumab
EXPERIMENTALPRGN-2009 at a dose of 5 x 10\^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18 years and older.
- Recurrent or metastatic cervical cancer (histologically or cytologically confirmed)
- Must have been treated with pembrolizumab, either as monotherapy or in combination, for atleast 6 weeks.
- Subjects must have histologically or cytologically confirmed HPV positive disease
- Measurable disease that can be accurately measured by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks from the time of enrollment.
- Must have adequate organ function
- Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.
- All patients must have the ability to understand and willingness to sign a written informed consent.
You may not qualify if:
- Prior chemotherapy, targeted therapy within 14 days; monoclonal antibody within 4 weeks; unresolved AEs.
- Immunodeficiency, active autoimmune disease on immunosuppression, or immunosuppressive therapy within 7 days. HIV eligible with disease control.
- Active hepatitis B (HBsAg+) or hepatitis C (HCV RT-PCR+) within 30 days of enrollment.
- History of non-infectious pneumonitis or interstitial lung disease.
- History of endocrine autoimmune disease (exceptions: treated Graves' disease; hypothyroidism on replacement).
- Live vaccine within 30 days prior to first dose.
- Patients with presence of other active malignancy within 1 year prior to study entry
- Known Central Nervous System (CNS) disease
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Known history of active tuberculosis (TB, Bacillus tuberculosis).
- Pregnant and lactating women are excluded from this study.
- Patients with a history of solid organ transplant.
- Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.
- Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Precigen, Inclead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
National Institute of Health
Bethesda, Maryland, 20892, United States
University of Washington
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2023
First Posted
December 5, 2023
Study Start
November 11, 2025
Primary Completion (Estimated)
November 11, 2026
Study Completion (Estimated)
November 30, 2030
Last Updated
April 23, 2026
Record last verified: 2026-04