At a glance
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A Phase 1b/2a Dose-escalation and Safety/Efficacy Evaluation Study of Pexa-Vec (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) in Combination With Cemiplimab (REGN2810; Anti-PD-1) in Patients With Metastatic or Unresectable Renal Cell Carcinoma (RCC)
In Brief
A Phase 1 clinical trial evaluating Pexastimogene Devacirepvec (Pexa-Vec) and Cemiplimab for Renal Cell Carcinoma. Completed, enrolled 95 participants across 21 sites in 3 countries.
Signals
Detailed Summary
This is a Phase 1b/2a, open-label, multi-center, dose-escalation and safety/efficacy evaluation trial of Pexa-Vec plus Cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC). The trial consists of a dose-escalation stage, where the maximum feasible dose of Pexa-Vec in combination with Cemiplimab will be determined, followed by an expansion stage. During the expansion patients will receive Cemiplimab alone or in combination with Pexa-Vec, which will be administered either through intravenous (IV) or intratumoral (IT) injection.
Study Details
Timeline
Arms & Interventions
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 3 x 10\^8 pfu. Cemiplimab will be administered via IV infusion every 3 weeks.
Pexa-Vec will be administered via IV infusion at a dose of 1 x 10\^9 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.
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. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
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. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
Interventions
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells
Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)