Recruiting
Phase 2

PRGN-2009 & Pembrolizumab

Sponsor:

Precigen, Inc

Code:

NCT06157151

Conditions

Cervical Cancer

HPV-Related Carcinoma

HPV-Related Malignancy

Recurrent Cervical Carcinoma

Metastatic Cervical Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRGN-2009 plus Pembrolizumab

Study Details

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.

Conditions

Cervical Cancer

HPV-Related Carcinoma

HPV-Related Malignancy

Recurrent Cervical Carcinoma

Metastatic Cervical Cancer

Study ID

NCT06157151

Start date

Nov 11, 2025

Status verified date

Apr, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

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.

Primary outcome measure

  • 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. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Amy Lankford

3015569900clinicaltrials@precigen.com

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Nou Yang

501-320-7749NYXiong@uams.edu

Principal Investigator:

Michael Birrer, MD, PhD

National Institute of Health

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Shannon Householder

shannon.householder@nih.gov

University of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

John Liao, MD

866-932-8588cvitrial@uw.edu

More Information

Sponsor

Precigen, Inc

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Human Papilloma Virus
  • Cervical Cancer
  • Pembrolizumab
  • Therapeutic Vaccine
  • Cervix Cancer
  • Resistance to Checkpoint Inhibitors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Precigen, Inc on 2026-04-23.