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NCT04006119 · ClinicalTrials.gov registry record · Phase 2
Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma
A Phase 2 study, sponsored by Alaunos Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT04006119: Clinical Trial Phase 2 study, sponsored by Alaunos Therapeutics.
NCT04006119 is a Phase 2 study that was terminated before completion, run by Alaunos Therapeutics. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04006119, a Phase 2 study, was terminated before completion, sponsored by Alaunos Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. Cemiplimab-rwlc (Libtayo) is an antibody (a kind of human protein) that is being tested to see if it will allow the body's immune system to work against glioblastoma tumors. Libtayo (cemiplimab-rwlc) is currently FDA approved in the United States for metastatic cutaneous cell carcinoma (CSCC), but is not approved in glioblastoma. Cemiplimab-rwlc may help your immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in combination with cemiplimab-rwlc to enhance the IL-12 mediated effect observed to date. The main purpose of this study is to evaluate the safety and efficacy of a single tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with cemiplimab-rwlc.
Primary Outcome
Evaluation of adverse events as assessed by CTCAE v5.0 will be based on the incidence, intensity and type of adverse event. Safety evaluations included the observed incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of toxicity Grade \>3, TEAEs leading to treatment dose modification, discontinuation, and death. Drug-related TEAEs were also assessed.
Interventions
- DRUG Cemiplimab-Rwlc
- BIOLOGICAL Ad-RTS-hIL-12
- DRUG Veledimex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2021-08-05 |
| Phase | Phase 2 |
Why NCT04006119 stopped before completion
NCT04006119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Cemiplimab-Rwlc is the first listed.
NCT04006119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04006119 about?
NCT04006119 is a clinical study titled "Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma". This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to...
What is the current status of trial NCT04006119?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2019-08-01. Estimated completion is 2021-08-05.
What interventions are being tested in trial NCT04006119?
The interventions under investigation include: Cemiplimab-Rwlc (DRUG), Ad-RTS-hIL-12 (BIOLOGICAL), Veledimex (DRUG).
Who is sponsoring clinical trial NCT04006119?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04006119's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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