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NCT03576612 · ClinicalTrials.gov registry record · Phase 1
GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas
A Phase 1 study, sponsored by Candel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT03576612 is a Phase 1 study that has completed, run by Candel Therapeutics. The registered enrollment target is 41 participants.
The verdict
NCT03576612, a Phase 1 study, has completed, sponsored by Candel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this phase I trial is to test the safety of combining GMCI, an immunostimulator, plus nivolumab, an immune checkpoint inhibitor (ICI), with standard of care radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas. Gene Mediated Cytotoxic Immunotherapy (GMCI) involves the use of aglatimagene besadenovec (AdV-tk) injection into the tumor site and oral valacyclovir to kill tumor cells and stimulate the immune system. Nivolumab is an immune checkpoint inhibitor that may also stimulate the immune system by blocking the PD-1 immune suppressive pathway. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors and temozolomide is a chemotherapy drug that kills tumor cells. Giving GMCI, nivolumab, radiation therapy, and temozolomide may work better in treating patients with high-grade gliomas
Interventions
- DRUG Temozolomide
- BIOLOGICAL Nivolumab
- RADIATION Radiation
- DRUG Valacyclovir
- BIOLOGICAL AdV-tk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-02-27 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03576612
The ClinicalTrials.gov registry entry for NCT03576612 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Candel Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT03576612 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03576612 about?
NCT03576612 is a clinical study titled "GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas". The purpose of this phase I trial is to test the safety of combining GMCI, an immunostimulator, plus nivolumab, an immune checkpoint inhibitor (ICI), with standard of care radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas. Gene Mediated Cytotoxic Immun...
What is the current status of trial NCT03576612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2018-02-27. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03576612?
The interventions under investigation include: Temozolomide (DRUG), Nivolumab (BIOLOGICAL), Radiation (RADIATION), Valacyclovir (DRUG), AdV-tk (BIOLOGICAL).
Who is sponsoring clinical trial NCT03576612?
This trial is sponsored by Candel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
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