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NCT03294083 · ClinicalTrials.gov registry record · Phase 1
A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
A Phase 1 study of Renal Cell Carcinoma, sponsored by SillaJen.
- Active
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
- 18
- Study locations
NCT03294083: Active Phase 1 study of Renal Cell Carcinoma, sponsored by SillaJen.
NCT03294083 is a Phase 1 study of Renal Cell Carcinoma that is active but no longer recruiting, run by SillaJen. The registered enrollment target is 89 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (63% lower). The trial reports 18 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03294083, a Phase 1 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by SillaJen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
Safety will be determined by assessing the incidence, severity, and frequency of all treatment-emergent adverse events (TEAEs), Grade 3 or greater AEs, serious adverse events (SAEs), laboratory toxicity, AEs requiring discontinuation of study agent(s), and deaths. The severity of all adverse events and laboratory abnormalities is assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Safety is monitored from the firs
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 |
What the registry record for NCT03294083 still lists
NCT03294083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (63% lower).
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.
NCT03294083 lists 18 locations in 5 states (Other, California, Florida).
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.
What interventions are being tested in trial NCT03294083?
The interventions under investigation include: Cemiplimab (BIOLOGICAL), Pexastimogene Devacirepvec (Pexa-Vec) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03294083?
This trial is sponsored by SillaJen, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT03294083's enrollment target sits among peer trials
89 57th of 121 higher than 65 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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