Combination treatment for recurrent or metastatic cervical cancer
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.
This study is testing if adding a new treatment called PRGN-2009 to pembrolizumab can help people with recurrent or metastatic cervical cancer who haven't responded to pembrolizumab alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Precigen, Inc Industry-sponsored |
| Drugs / interventions | pembrolizumab, chemotherapy |
| Locations | 3 sites (Little Rock, Arkansas and 2 other locations) |
| Trial ID | NCT06157151 on ClinicalTrials.gov |
What this trial studies
This randomized trial evaluates the efficacy and safety of PRGN-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with recurrent or metastatic cervical cancer who are resistant to pembrolizumab. Participants will be randomly assigned to receive either the combination treatment or pembrolizumab alone. The study aims to determine if the addition of PRGN-2009 can improve outcomes for patients who have already shown resistance to standard pembrolizumab therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with recurrent or metastatic cervical cancer that is resistant to pembrolizumab and meets specific eligibility criteria.
Not a fit: Patients who have not been treated with pembrolizumab or those with other types of cervical cancer not meeting the study criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent or metastatic cervical cancer who have not responded to existing therapies.
How similar studies have performed: Other studies have shown promise in combining immunotherapies with therapeutic vaccines, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Little Rock, Arkansas and 2 other locations
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
- National Institute of Health — Bethesda, Maryland, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Amy Lankford
- Email: clinicaltrials@precigen.com
- Phone: 3015569900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.