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NCT07468136 · ClinicalTrials.gov registry record · Phase 1
Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas
A Phase 1 study, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT07468136: Recruiting Phase 1 study, sponsored by Mayo Clinic.
NCT07468136 is a Phase 1 study that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07468136, a Phase 1 study, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This phase I/II trial tests the safety, side effects best dose and effect of retifanlimab with or without difluoromethylornithine (DFMO) for the treatment of high grade gliomas that are growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. DFMO is in a class of medications called ornithine decarboxylase (ODC) inhibitors. It works by blocking the action of a substance that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Giving retifanlimab with or without DFMO mat be safe, tolerable and/or effective in treating patients with progressive high grade glioma.
Primary Outcome
Will use a modified Bayesian Optimal Interval phase I/II (BOIN12) trial design to identify a dose level that is tolerable and has sufficient/optimal pharmacodynamic effects \[e.g., maximum tolerated dose (MTD)\]. Will evaluate toxicity up front to determine dose levels that have acceptable tolerability. Both dose limiting toxicity and pharmacodynamic activity will be used to identify the best dose to bring forward for the phase IIa portion.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Lumbar Puncture
- PROCEDURE Magnetic Resonance Imaging
- DRUG Eflornithine
- BIOLOGICAL Retifanlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2026-06-23 |
| Est. Completion | 2030-10-25 |
| Phase | Phase 1 |
What NCT07468136 shows while recruiting
NCT07468136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07468136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07468136 about?
NCT07468136 is a clinical study titled "Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas". This phase I/II trial tests the safety, side effects best dose and effect of retifanlimab with or without difluoromethylornithine (DFMO) for the treatment of high grade gliomas that are growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as retifanlimab...
What is the current status of trial NCT07468136?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2026-06-23. Estimated completion is 2030-10-25.
What interventions are being tested in trial NCT07468136?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Lumbar Puncture (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Eflornithine (DRUG), Retifanlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07468136?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07468136's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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