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Intratumoral Injection of Autologous CD1c (BDCA-1)+ myDC, AS01B, and Ipilimumab Plus Systemic Nivolumab

Study acronym: myDAvIpNi
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Dec 24, 2025 → Apr 23, 2027
Primary endpoint reworded 1 of 3 changed
See other at-risk trials from Universitair Ziekenhuis Brussel

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 24, 2025 to Apr 23, 2027 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment closed, study ongoing
    • Study completion pushed from Dec 24, 2025 to Dec 23, 2027
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 3 of 6 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
    • Study title revised
  2. Phase: Phase 1 to Phase 1/2v5 Show 9 more changesShow less
    • Enrollment target: 9 to 18
    • Primary and study completion dates: Dec 24, 2020 to Dec 24, 2025
    • Primary endpoints: 1 to 3
    • Trial status: Completed to Recruiting
    • Interventions: intratumoral injection of autologous CD1c (BDCA-1)+ myDC (Drug) to IV nivolumab (Drug), Intratumoral injection of ipilimumab and AS01b (Drug), intratumoral injection of autologous CD1c (BDCA-1)+ myDC (Drug)
    • Secondary endpoints: 1 to 6
    • Study description expanded, about 18 words
    • Site details revised
    • Study arms: 0 to 2
  3. Trial status: Recruiting to Completedv4 Show 4 more changesShow less
    • Enrollment target: estimated 6 to confirmed 9
    • Primary completion date changed from estimate of Apr 2021 to Dec 24, 2020
    • Study completion date changed from estimate of Jul 2021 to Dec 24, 2020
    • Site details revised
  4. Primary completion date: Apr 2019 to Apr 2021
    • Study completion date: Jul 2019 to Jul 2021
    v3
  5. Primary completion date: Jan 2019 to Apr 2019
    • Study completion date: Apr 2019 to Jul 2019
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II trial aims at investigating the role and effect of autologous CD1c (BDCA-1)+ myeloid dendritic cells in combination with intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B compared to a combinatorial immunotherapy regimen using intratumoral injection of the CTLA-4 blocking monoclonal antibody (mAb) ipilimumab and the immunoligand AS01B. Concomitantly, nivolumab (a PD-1 blocking mAb) will be administered intravenously in both arms.
Trial Details
NCT Number NCT03707808
Lead Sponsor Universitair Ziekenhuis Brussel
Conditions
(from sponsor)		 Solid Tumor, Metastases to Soft Tissue
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov