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Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK

Study acronym: MIRV
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Study sites: 8 to 9v9
  2. Trial sites expanded: 5 → 8 locationsv8
  3. Study sites: 4 to 5v7
  4. Study sites: 3 to 4v6
  5. Study sites: 2 to 3v5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Dec 2025 to Jan 12, 2026
    • Publications: details revised at 10 of 10 entries
    v4
  2. Lead sponsor: C17 Council to St. Justine's Hospitalv3 Show 4 more changesShow less
    • Start date: Apr 1, 2025 to Dec 2025
    • Study sites: 0 to 1
    • Study completion date: Apr 2035 to Apr 2033
    • Eligibility criteria expanded, about 14 words
  3. Start date: Jan 1, 2025 to Apr 1, 2025
    • Primary completion date: Jan 2030 to Apr 2030
    • Study completion date: Jan 2035 to Apr 2035
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
St. Justine's Hospital
28 trials monitored
See 2 trials at risk
Glioma
1,251 trials monitored
See 88 trials at risk
This is a 3-part open-label study (feasibility phase, treatment phase and follow-up phase) of orally administered mirdametinib in combination with intravenous vinblastine chemotherapy in patients with PLGG with activation of MAPK pathway. Feasibility Phase: The maximum tolerated/recommended phase 2 dose (MTD/RP2D) of the mirdametinib plus vinblastine combination will be assessed using a modified Rolling-6 design. Treatment Phase: Patients will receive mirdametinib twice daily (continuously) at a fixed dose (2mg/m2 po BID up to 4 mg BID) for a total of 13 cycles (28 days cycle). Weekly intravenous vinblastine at MTD will be given for a total of 17 cycles. If adverse events occur, two dose reductions are allowed. Follow-up Phase: Following the end of treatment, patients will be scheduled for a follow-up visit every 6 months for 36 months to evaluate PFS, TTP and OS.
Trial Details
NCT Number NCT06666348
Lead Sponsor St. Justine's Hospital
Conditions
(from sponsor)		 Pediatric Low-grade Glioma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov