A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma

Part of paid clinical trials in Irvine, California.

Sponsor
SillaJen, Inc.
Study ID
NCT03294083
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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.

Key Dates

First listed
Sep 26, 2017
Start date
Jun 19, 2018
Status verified
May 2026
Primary completion
Feb 16, 2023
Completion
Feb 16, 2023

Study Design

Enrollment
95 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1, Dose escalation 3 x 10^8 pfu
    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.
  • Experimental: Part 1, Dose escalation 1 x 10^9 pfu
    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.
  • Experimental: Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab
    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)
  • Experimental: Part 2-Arm B, Cemiplimab
    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)
  • Experimental: Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab
    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)
  • Experimental: Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab
    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)

Primary Outcome Measure

Number and Percentage of Participants With Adverse Events From Pexa-Vec Administered by IV Infusions or IT Injections in Combination With IV Cemiplimab [ Time Frame: Through study completion without survival follow-up period, an average of 1 year ]

Locations (5)

FacilityCityStateZIPSite coordinators
Site 2644 University of California, IrvineIrvineCalifornia92868-
Site 2641 University of MiamiMiamiFlorida33136-
Site 2643 Washington UniversitySt LouisMissouri63141-
Site 2642 Billings ClinicBillingsMontana59101-
Site 2646 The Ohio State UniversityColumbusOhio43201-

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By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Site 2644 University of California, Irvine· Irvine, CASite 2641 University of Miami· Miami, FLSite 2643 Washington University· St Louis, MOSite 2642 Billings Clinic· Billings, MTSite 2646 The Ohio State University· Columbus, OH

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