NCT06157151 PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
| NCT ID | NCT06157151 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Precigen, Inc |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-11-11 |
| Primary Completion | 2026-11-11 |
Trial Parameters
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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.
Eligibility 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.
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