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NCT02311582 · ClinicalTrials.gov registry record · Phase 1
MK-3475 in Combination With MRI-guided Laser Ablation in Recurrent Malignant Gliomas
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT02311582: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT02311582 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02311582, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
The blood brain barrier (BBB) is a major obstacle to drug delivery in the treatment of malignant brain tumors including glioblastoma multiforme (GBM). MRI-guided laser ablation (MLA) has been noted to disrupt peritumoral the blood brain barrier (BBB), which may then lead to increased access of new tumor antigens to the lymphovascular system and vice versa of immune effector cells to the tumor for effective activation of the immune system, and tumor infiltration, respectively. Therefore, the combination of MK-3475 and MLA as proposed in this protocol is hypothesized to create a therapeutic combinatorial effect in which MLA increases material access to promote immune activation and then MK-3475 maximizes these tumor-specific immune reactions to impart effective tumor control.
Primary Outcome
The MTD is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experienced dose-limiting toxicity during the first cycle. Dose escalations will proceed until the MTD has been reached, or failing that, 200 mg of MK-3475 every 3 weeks will be considered the MTD.
Interventions
- BIOLOGICAL MK-3475
- DEVICE MRI-guided laser ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-08-05 |
| Est. Completion | 2024-04-15 |
| Phase | Phase 1 |
What the finished NCT02311582 record still lists
NCT02311582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which MK-3475 is the first listed.
NCT02311582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02311582 about?
NCT02311582 is a clinical study titled "MK-3475 in Combination With MRI-guided Laser Ablation in Recurrent Malignant Gliomas". The blood brain barrier (BBB) is a major obstacle to drug delivery in the treatment of malignant brain tumors including glioblastoma multiforme (GBM). MRI-guided laser ablation (MLA) has been noted to disrupt peritumoral the blood brain barrier (BBB), which may then lead to increased access of new t...
What is the current status of trial NCT02311582?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2015-08-05. Estimated completion is 2024-04-15.
What interventions are being tested in trial NCT02311582?
The interventions under investigation include: MK-3475 (BIOLOGICAL), MRI-guided laser ablation (DEVICE).
Who is sponsoring clinical trial NCT02311582?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02311582's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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