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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 is a Phase 1 study that has completed, run by Alaunos Therapeutics. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03636477
The ClinicalTrials.gov registry entry for NCT03636477 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alaunos Therapeutics, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03636477 reports 0 study locations.
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.
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