Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06157151 | PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer | PHASE2 | RECRUITING | 24 | — | — | Nov 11, 2025 | Nov 30, 2030 | Apr 23, 2026 | 3 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| PRGN-2009 plus Pembrolizumab | EXPERIMENTAL | PRGN-2009 at a dose of 5 x 10\^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w |
| Name | Type | Description |
|---|---|---|
| PRGN-2009 plus Pembrolizumab | BIOLOGICAL | 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. |
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 confirm...