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Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion

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

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  1. Eligibility criteria shortened, about 4 wordsv9
  2. Primary completion date: Dec 1, 2025 to Dec 31, 2026v8 Show 4 more changesShow less
    • Study completion date: Dec 1, 2027 to Dec 31, 2029
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints: 5 to 7
    • Publications: 2 to 3
  3. Lead sponsor: Sahlgrenska University Hospital to Vastra Gotaland Regionv7
  4. Primary completion date: Dec 1, 2023 to Dec 1, 2025
    • Study completion date: Dec 1, 2025 to Dec 1, 2027
    v6
  5. Primary completion date: Dec 1, 2021 to Dec 1, 2023
    • Study completion date: Dec 2023 to Dec 1, 2025
    • Site details revised at 1 of 4 sites
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Jun 2020 to Dec 1, 2021v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2018 to Apr 1, 2019
    • Site details revised at 4 of 4 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Vastra Gotaland Region
139 trials monitored
See 11 trials at risk
Melanoma
1,092 trials monitored
See 60 trials at risk
To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms. In the first phase Ib part, 20 patients will be enrolled and followed for a minimum of 3 months. An independent data safety monitoring board (DSMB) will continuously review safety and judge the seriousness of the events and also recommend the study to stop if necessary. If the DSMB do not find safety issues, the trial will continue as a phase II trial.
Trial Details
NCT Number NCT03685890
Lead Sponsor Vastra Gotaland Region
Conditions
(from sponsor)		 Melanoma, In-Transit Metastasis
Related terms Melanoma
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov