Trials / Active Not Recruiting
Active Not RecruitingNCT03294083
A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
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)
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 89 (actual)
- Sponsor
- SillaJen, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2018-06-07
- Primary completion
- 2023-08-01
- Completion
- 2023-11-01
- First posted
- 2017-09-26
- Last updated
- 2022-10-27
Locations
18 sites across 3 countries: United States, Australia, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03294083. Inclusion in this directory is not an endorsement.