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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: Completed Phase 1 study, sponsored by Candel Therapeutics.
NCT03576612 is a Phase 1 study that has completed, run by Candel Therapeutics. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be used for scoring toxicity and adverse events. The severity and frequency of toxicity will be tabulated by the tested dose or doses using descriptive statistics. The proportions of subjects who experienced grade 3 or above toxicities will be estimated, along with 95% confidence intervals by each type of toxicity.
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 |
What the finished NCT03576612 record still lists
NCT03576612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT03576612 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03576612's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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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