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NCT06610682 · ClinicalTrials.gov registry record · Early Phase 1
Feasibility of CSF and Plasma ctDNA in BRAF-altered Glioma During Treatment With Plixorafenib
A Early Phase 1 study of BRAF V600E Mutation, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06610682: Recruiting Early Phase 1 study of BRAF V600E Mutation, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT06610682 is a Early Phase 1 study of BRAF V600E Mutation that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06610682, a Early Phase 1 study of BRAF V600E Mutation, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Evaluating the sensitivity and feasibility of using ctDNA assays optimized for detecting very low ctDNA counts from cerebrospinal fluid (CSF) and plasma. The investigators will evaluate the sensitivity of ctDNA from plasma and CSF at baseline (defined as Cycle1 Day1 (C1D1) pre-treatment) and over time in response to treatment with plixorafenib co-administered with cobicistat in BRAF-V600E mutant glioma refractory to prior therapies.
Primary Outcome
Proportion of patients with detectable ctDNA in CSF and/or plasma detected at surgery, baseline (C1D1), and pre-Cycle 2 (week 4).
Conditions Studied
Interventions
- DRUG Plixorafenib
- DRUG Cobicistat 150 MG [Tybost]
Study Locations (1)
Maryland
- Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-04-07 |
| Est. Completion | 2027-06-30 |
| Phase | Early Phase 1 |
What NCT06610682 shows while recruiting
NCT06610682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).
The record links to 1 condition, with BRAF V600E Mutation appearing as the primary indexed condition, and to 2 interventions - of which Plixorafenib is the first listed.
NCT06610682 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06610682 about?
NCT06610682 is a clinical study titled "Feasibility of CSF and Plasma ctDNA in BRAF-altered Glioma During Treatment With Plixorafenib". Evaluating the sensitivity and feasibility of using ctDNA assays optimized for detecting very low ctDNA counts from cerebrospinal fluid (CSF) and plasma. The investigators will evaluate the sensitivity of ctDNA from plasma and CSF at baseline (defined as Cycle1 Day1 (C1D1) pre-treatment) and over ti...
What is the current status of trial NCT06610682?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2025-04-07. Estimated completion is 2027-06-30.
What conditions does trial NCT06610682 study?
This clinical trial studies the following conditions: BRAF V600E Mutation.
What interventions are being tested in trial NCT06610682?
The interventions under investigation include: Plixorafenib (DRUG), Cobicistat 150 MG [Tybost] (DRUG).
Who is sponsoring clinical trial NCT06610682?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06610682 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06610682's enrollment target sits among peer trials
15 1404th of 2000 higher than 527 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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