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Also known as Pexastimogene Devacirepvec (Pexa-Vec)
Pexastimogene Devacirepvec · 1 trial · 1 indication
MTD/MFD of Pexa-Vec administered by IV infusion in combination with Cemiplimab
Safety will be determined by assessing the severity and frequency of adverse events and laboratory toxicity using CTCAE v4.03
Evaluate anti-tumor activity and efficacy of IV or IT Pexa-Vec combined with IV Cemiplimab with respect to overall response rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
| Arm | Type | Description |
|---|---|---|
| Part 1, Dose escalation | EXPERIMENTAL | Pexa-Vec will be administered via IV infusion at a dose of 3 x 10\^8 pfu once per week for 4 treatments. Based on the occurrence of dose-limiting toxicities, patients may subsequently be enrolled to receive Pexa-Vec on the same schedule at a dose of 1 x 10\^9 pfu. Cemiplimab will be administered via IV infusion every 3 weeks. |
| Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | EXPERIMENTAL | Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. |
| Part 2-Arm B, Cemiplimab | EXPERIMENTAL | Cemiplimab will be administered via IV infusion every 3 weeks. At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks. |
| Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | EXPERIMENTAL | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. |
| Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | EXPERIMENTAL | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Pexastimogene Devacirepvec (Pexa-Vec) | BIOLOGICAL | Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells |
| Cemiplimab | BIOLOGICAL | Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
Inclusion Criteria: * Histologically or cytologically confirmed metastatic or unresectable clear cell renal cell carcinoma (ccRCC) * Part 2 Arm D ONLY: Patients must be refractory to anti PD-1 or anti-PD-L1 (either as monotherapy or in-combination with other approved checkpoint inhibitors or target...
Pexastimogene Devacirepvec, also known as Pexa-Vec, is an investigational gene therapy being studied for the treatment of Renal Cell Carcinoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Pexastimogene Devacirepvec is a gene therapy that belongs to the -vec/-gene (gene tx) target class. It is designed to deliver genetic material into cells to produce a therapeutic effect, specifically in the context of Renal Cell Carcinoma.
Pexastimogene Devacirepvec is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN.
Pexastimogene Devacirepvec is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for the treatment of Renal Cell Carcinoma.
Pexastimogene Devacirepvec is being studied in a Phase 1 clinical trial with the identifier NCT03294083. This trial, titled 'A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma,' is active but not recruiting and has an enrollment of 89 participants.
Yes, Pexastimogene Devacirepvec is also known as Pexa-Vec. Both names refer to the same investigational gene therapy being developed for Renal Cell Carcinoma.