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NCT03636477 · ClinicalTrials.gov registry record · Phase 1
A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102
A Phase 1 study, sponsored by Alaunos Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03636477: Completed Phase 1 study, sponsored by Alaunos Therapeutics.
NCT03636477 is a Phase 1 study that has completed, run by Alaunos Therapeutics. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03636477, a Phase 1 study, has completed, sponsored by Alaunos Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human interleukin-12 (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. Nivolumab 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. Opdivo (Nivolumab) is currently FDA approved in the United States for melanoma (a type of skin cancer), non-small cell lung cancer, renal cell cancer (a type of kidney cancer), Hodgkin's lymphoma but is not approved in glioblastoma. Nivolumab may help your immune system detect and attack cancer cells. Ad-RTS-hIL-12 and veledimex will be given in combination with Nivolumab to enhance the IL-12 mediated effect observed to date. The main purpose of this substudy is to evaluate the safety and tolerability of a single tumoral injection of Ad-RTS-hIL-12 given with oral veledimex in combination with nivolumab.
Primary Outcome
Evaluation of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 will be based on the incidence, intensity and type of adverse event. AEs will be regarded as treatment-emergent adverse events (TEAEs) during the treatment period regardless of relationship to study drug if: • The AE occurred or worsened from baseline during or after administration of the first dose of study drug (on or after Day 0).
Interventions
- DRUG Nivolumab
- BIOLOGICAL Ad-RTS-hIL-12
- DRUG veledimex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 1 |
What the finished NCT03636477 record still lists
NCT03636477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03636477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03636477 about?
NCT03636477 is a clinical study titled "A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102". This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human interleukin-12 (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 w...
What is the current status of trial NCT03636477?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-06-18. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT03636477?
The interventions under investigation include: Nivolumab (DRUG), Ad-RTS-hIL-12 (BIOLOGICAL), veledimex (DRUG).
Who is sponsoring clinical trial NCT03636477?
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 NCT03636477's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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