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

NCT03294083 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2022-10-27

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

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

BIOLOGICAL

Cemiplimab

Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-07
Primary Completion
2023-08-31
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294083 on ClinicalTrials.gov