PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
NCT ID: NCT06157151
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
46 participants
INTERVENTIONAL
2025-03-21
2028-01-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PRGN-2009 plus Pembrolizumab
PRGN-2009 at a dose of 5 x 10\^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w
PRGN-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.
Pembrolizumab alone
Pembrolizumab, 400mg q6w
Pembrolizumab alone
Subjects randomized will receive IV infusion of pembrolizumab (400 mg) administered every 6 weeks.
Interventions
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PRGN-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.
Pembrolizumab alone
Subjects randomized will receive IV infusion of pembrolizumab (400 mg) administered every 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant.
* Must have been treated with pembrolizumab, either as monotherapy or in combination
* Patients must have received no more than two prior systemic regimens in the recurrent or metastatic setting
* Tumors are confirmed positive for PD-L1 and HPV16/18
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Precigen, Inc
INDUSTRY
National Cancer Institute (NCI)
NIH
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Nou Yang
Role: primary
Shannon Householder
Role: primary
John Liao, MD
Role: primary
Other Identifiers
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PRGN-2009-201
Identifier Type: -
Identifier Source: org_study_id