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RecruitingInterventionalPhase 2

A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.

NCT ID: NCT06157151Sponsor: Precigen, IncLast updated: 2026-04-23

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.

Detailed description

This is a Phase 2 study of PRGN-2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. Patients meeting all eligibility criteria who consent to participate in the study will receive PRGN-2009 (5 x 10\^11 PU, subcutaneous injection) every 3 weeks for three administrations, thereafter every 6 weeks, plus pembrolizumab (400 mg IV) every 6 weeks.

Arms & interventions

  • BiologicalPRGN-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.

Outcome measures

Primary

  • 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.

    The ORR will be calculated as the combination of subjects achieving a complete response or a partial response per RECIST v1.1. ORR will be calculated and presented with 2-sided 95% confidence interval.

    Time frame: 1 year

Secondary

  • Safety of PRGN-2009 in combination with pembrolizumab

    Time frame: 1 year

  • Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab

    Time frame: 1 year

  • Best Overall Responses (BOR) and Disease Control Rate (DCR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab

    Time frame: 1 year

  • Time to Response and Duration of Responses following treatment with PRGN-2009 in combination with pembrolizumab

    Time frame: 1 year

  • Vector shedding following subcutaneous administration of PRGN-2009

    Time frame: Up to 4 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

Recruiting
Nou Yang · Contact
Michael Birrer, MD, PhD · Principal Investigator

National Institute of Health

Bethesda, Maryland, 20892

Recruiting
Shannon Householder · Contact

University of Washington

Seattle, Washington, 98109

Recruiting
John Liao, MD · Contact
PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer | Cancerify