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A Phase I/II Clinical Trial on the Per-operative Intratumoral Administration of Myeloid Dendritic Cells Plus Ipilimumab and Nivolumab, Followed by Repeated Intracavitary Plus Intravenous Administration of Nivolumab in Patients With Recurrent Glioblastoma.

Study acronym: GlitIpNi
StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Phase: Phase 1 to Phase 1/2v5 Show 5 more changesShow less
    • Primary and study completion dates: Nov 17, 2023 to Nov 17, 2026
    • Interventions: Ipilimumab (YervoyTM, 50 mg/10 mL solution) (Drug), Nivolumab (OpdivoTM, 40 mg/4mL solution) (Drug) to Autologous CD1c(BDCA-1)+ /CD141(BDCA-3)+ myDC (Biological), Ipilimumab (YervoyTM, 50 mg/10 mL solution) (Drug), Nivolumab (OpdivoTM, 40…
    • Eligibility criteria expanded, about 146 words
    • Study description expanded, about 105 words
    • Study title expanded, about 21 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 6 to confirmed 110
    • Site details revised
    v4
  3. Primary and study completion dates: Nov 17, 2019 to Nov 17, 2023v3
  4. Primary completion date: Nov 17, 2018 to Nov 17, 2019v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase I/II clinical trial on the per-operative intra-tumoral administration of myeloid dendritic cells plus ipilimumab and nivolumab, followed by repeated intracavitary administration of ipilimumab and nivolumab plus intravenous administration of nivolumab in patients with recurrent glioblastoma. The aim of this clinical trial is to exploit the potential synergy of combined intra-tumoral CTLA-4 and autologous CD1c(BDCA-1)+/CD141(BDCA-3)+ myDC and systemic PD-1 blockade while minimizing the risk for increased immune-related toxicity by intratumoral administration of the CTLA-blocking mAb ipilimumab following the resection of the recurrent glioblastoma.
Trial Details
NCT Number NCT03233152
Lead Sponsor Universitair Ziekenhuis Brussel
Conditions
(from sponsor)		 Glioblastoma
Related terms Glioblastoma, Recurrence
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov