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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03294083 | A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma | PHASE1 | ACTIVE NOT_RECRUITING | 89 | — | — | Jun 7, 2018 | Nov 1, 2023 | Oct 27, 2022 | 18 | United States, Australia +1 |
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...