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Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma

Study acronym: MiniVan
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Nov 30, 2025 to Sep 30, 2026v16
  2. Primary completion date changed from estimate of May 30, 2025 to Jun 30, 2025 Completion date: Jul 31, 2025 to Nov 30, 2025 · Publications: details revised at 45 of 51 entriesv15 Show 2 more changesShow less
    • Completion date: Jul 31, 2025 to Nov 30, 2025
    • Publications: details revised at 45 of 51 entries
  3. Primary completion date: Sep 30, 2024 to May 30, 2025 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 3 of 3 sites · Publications: details revised at 45 of 51 entriesv14 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    • Publications: details revised at 45 of 51 entries
  4. Primary completion date: Nov 2023 to Sep 30, 2024 Enrollment target: 36 to 44 · Completion date: Nov 2023 to Jul 31, 2025v13 Show 2 more changesShow less
    • Enrollment target: 36 to 44
    • Completion date: Nov 2023 to Jul 31, 2025
  5. Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary and study completion dates: Jun 2022 to Nov 2023v11
  2. Eligibility criteria revisedv10 See this version in full on ClinicalTrials.gov ↗
  3. Primary and study completion dates: May 2021 to Jun 2022v9
  4. Study sites revised (3) Study title expanded, about 6 wordsv8 Show 1 more changeShow less
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary and study completion dates: May 2020 to May 2021 Study sites: 2 to 3v7 Show 1 more changeShow less
    • Study sites: 2 to 3
  6. Re-verified, no change to tracked fieldsv6
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of May 2018 to May 24, 2018v5 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of May 2018 to May 24, 2018
  8. Primary and study completion dates: Jan 2019 to May 2020 Start date: Oct 2017 to May 2018v4 Show 1 more changeShow less
    • Start date: Oct 2017 to May 2018
  9. Start date: Jan 2017 to Oct 2017 Collaborators: 3 to 6v3 Show 1 more changeShow less
    • Collaborators: 3 to 6

    See this version in full on ClinicalTrials.gov ↗

  10. Secondary endpoints revised (3)v2 See this version in full on ClinicalTrials.gov ↗
  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.
Neuroblastoma, the most common extra-cranial solid tumour in children, remains one of the major challenges in paediatric oncology. A promising way to further improve outcome in this disease appears to be the development of adjuvant therapeutic strategies. In this research the anti-GD2 antibody, which is a standard treatment, is to be combined with 131-l Metaiodobenzylguanidine (mlBG) and anti-Programmed Cell Death Protein 1 (anti-PD1) antibody Nivolumab - the investigated drugs - with the aim of generating sustained anti-neuroblastoma immunity. In particular it will be determined the safety and tolerability of the novel combination as well as documented any evidence of efficacy in paediatric patients with relapsed and refractory high risk neuroblastoma. This study is sponsored by the University Hospital Southampton and will take place in 4 hospitals in the United Kingdom, Germany and USA. The estimated duration of the study is 2 years, starting in December 2016. This is an "adaptive study". Such design uses accumulating of data from the ongoing trial to modify aspects of the study (e.g. duration, number of treatments) without undermining its validity or integrity. There will be 3 cohorts of patients. As safety of Nivolumab is well established, Cohort 1 will assess its safety and tolerability in combination with 131-l mlBG. Cohort 2 will then add anti-GD2 to the drug combination, assessing safety and tolerability. Cohort 3 will escalate all 3 agents to the full 100% dose level to assure safety for expanded analyses of clinical and laboratory data at that dose level. Patients will initially be recruited into Cohort 1. Patients must have completed at least 12 weeks of trial treatment without reaching a Dose Limiting Toxicity before a patient can be recruited to the next cohort. A minimum of 3 evaluable patients will be treated in cohorts 1-3. Assuming the full dose combination therapy (cohort) is tolerable, 15 evaluable patients will be treated.
Trial Details
NCT Number NCT02914405
Lead Sponsor University Hospital Southampton NHS Foundation Trust
Collaborators: University College London Hospitals, University of Wisconsin, Madison, University Hospital Greifswald, Solving Kids' Cancer US/EU, Joining Against Cancer in Kids, The Band of Parents
Conditions Neuroblastoma
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov