Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
NCT03294083 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- BIOLOGICAL Cemiplimab
- BIOLOGICAL Pexastimogene Devacirepvec (Pexa-Vec)
Study Locations (18)
Other
- Site 2632 Flinders Medical Centre — Bedford Park
- Site 2612 Kyungpook National University Chilgok Hospital — Daegu
- Site 2616 Chungnam National University Hospital — Daejeon
- Site 2618 Chonnam National University Hwasun Hospital — Gwangju
- Site 2622 Gachon University Gil Medical Center — Incheon
- Site 2613 Dong-A University Hospital — Pusan
- Site 2619 Pusan National University Hospital — Pusan
- Site 2617 CHA University, CHA Bundang Medical Center — Seongnam
- Site 2620 Seoul National University Bundang Hospital — Seongnam-si
- Site 2615 Korea University Anam Hospital — Seoul
- Site 2610 Severance Hospital, Yonsei University Health System — Seoul
- Site 2623 Ajou University Hospital — Suwon
- Site 2625 Wonju Severance Christian Hospital — Wŏnju
- Site 2624 Pusan National University Yangsan Hospital — Yangsan
California
- Site 2644 University of California, Irvine — Irvine
Florida
- Site 2641 University of Miami — Miami
Missouri
- Site 2643 Washington University — St Louis
Ohio
- Site 2646 The Ohio State University — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2018-06-07 |
| Est. Completion | 2023-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03294083
The ClinicalTrials.gov registry entry for NCT03294083 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SillaJen, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Cemiplimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03294083 reports 18 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03294083 about?
NCT03294083 is a clinical study titled "A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma". 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 comb...
What is the current status of trial NCT03294083?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2018-06-07. Estimated completion is 2023-11.
What conditions does trial NCT03294083 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03294083?
The interventions under investigation include: Cemiplimab (BIOLOGICAL), Pexastimogene Devacirepvec (Pexa-Vec) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03294083?
This trial is sponsored by SillaJen, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03294083 being conducted?
This trial has 18 study locations across California, Florida, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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