PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer

Recruiting now · Phase 2

Conditions studied: Cervical Cancer, HPV-Related Carcinoma, HPV-Related Malignancy, Recurrent Cervical Carcinoma, Metastatic Cervical Cancer

In brief

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.

Key facts

Study ID

NCT06157151

Run by

Precigen, Inc

People needed

24

Starts

2025-11-11

Expected to finish

2030-11-30

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• National Institute of Health — Bethesda, Maryland, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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