New combo aims to outsmart Drug-Resistant cervical cancer
NCT ID NCT06157151
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 study is testing whether adding an experimental therapy called PRGN-2009 to the immunotherapy drug pembrolizumab can help shrink tumors in people with recurrent or metastatic cervical cancer that has stopped responding to pembrolizumab alone. About 24 adults with HPV-positive cervical cancer will receive injections of PRGN-2009 plus pembrolizumab every few weeks. The main goal is to see how many patients experience tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PRGN-2009 (a vaccine-like therapy) combined with pembrolizumab (an immunotherapy drug)
- What this could lead to
- If successful, this combination could shrink tumors or slow cancer growth in patients whose cervical cancer has stopped responding to standard immunotherapy.
- What could go wrong
- This is a small, early-phase study with only 24 participants, so results may not apply to all patients. Side effects from the combination could be serious, and the treatment may not work for everyone.
Why investors are watching
Precigen is testing its experimental therapy PRGN-2009 combined with pembrolizumab in 24 patients with recurrent or metastatic cervical cancer that no longer responds to pembrolizumab alone. For a micro-cap company, this small Phase 2 readout could determine whether its drug has a future in a hard-to-treat patient group.
If it works: A positive result could show that PRGN-2009 restores pembrolizumab's effectiveness, giving Precigen a path to a larger trial and a potential commercial product in cervical cancer.
If it fails: Phase 2 trials fail often, and this one enrolls only 24 patients, so a weak response or safety problems could end the program and hurt the company's prospects.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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National Institute of Health
RECRUITINGBethesda, Maryland, 20892, United States
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University of Arkansas for Medical Sciences
RECRUITINGLittle Rock, Arkansas, 72205, United States
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University of Washington
RECRUITINGSeattle, Washington, 98109, United States
Contact Email: •••••@•••••
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