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New combo aims to outsmart Drug-Resistant cervical cancer

NCT ID NCT06157151

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • National Institute of Health

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98109, United States

    Contact Email: •••••@•••••

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