PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervi
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.
| Condition(s) | Cervical Cancer, HPV-Related Carcinoma, HPV-Related Malignancy, Recurrent Cervical Carcinoma, Metastatic Cervical Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Precigen, Inc |
| Locations | Little Rock, Arkansas, United States; Bethesda, Maryland, United States; Seattle, Washington, United States |
| Start date | 2025-11-11 |
| NCT ID | NCT06157151 |
| Official listing | https://clinicaltrials.gov/study/NCT06157151 |