Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRGN-2009 plus Pembrolizumab · 1 trial · 5 indications
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...
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PRGN-2009 plus Pembrolizumab is an investigational combination therapy being studied for the treatment of recurrent or metastatic cervical cancer, including HPV-related carcinoma and HPV-related malignancy. It is currently in Phase 2 clinical development for these indications.
PRGN-2009 plus Pembrolizumab is being developed by Precigen, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PGEN. The company is conducting a Phase 2 clinical trial to evaluate this combination therapy in patients with cervical cancer.
PRGN-2009 plus Pembrolizumab is in Phase 2 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. A Phase 2 trial is currently recruiting patients with recurrent or metastatic cervical cancer in the United States.
PRGN-2009 plus Pembrolizumab is being studied in a single Phase 2 clinical trial with the identifier NCT06157151. This trial is titled 'PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer' and is currently recruiting participants in the United States.
The Phase 2 trial of PRGN-2009 plus Pembrolizumab (NCT06157151) is an open-label, uncontrolled study with a planned enrollment of 24 patients. It is not randomized or double-blinded. The trial is recruiting adults aged 18 years and older of all sexes with recurrent or metastatic cervical cancer.