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Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy

Study acronym: MINER
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv14
  2. Minor Enrollment target: 570 to 770v13
  3. Minor Enrollment target: 520 to 570v12
  4. Notable Primary and study completion dates: Nov 2024 to Nov 2029v11
  5. Minor Study sites: 2 to 3v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv9
  2. Minor Enrollment target: 440 to 520v8
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Notable Trial status: Suspended to Recruiting
    • Site details revised at 2 of 2 sites
    • Eligibility criteria shortened, about 1 word
    v6
  5. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Context of the Covid-19 pandemic
    • Site details revised at 2 of 2 sites
    v5
  6. Minor Re-verified, no change to tracked fieldsv4
  7. Minor Start date changed from estimate of May 2018 to May 28, 2018
    • Site details revised at 1 of 2 sites
    v3
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a translational, open-label, multi-site, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers. The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol. Patients with any of the following tumor types may be enrolled in the trial: * Non-Small Cell Lung Cancer (NSCLC), * Head and neck cancer, * Melanoma, * Bladder cancer, * Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option. For each included patient, tumor biopsy specimens and blood samples will be collected at different time points. All included patients will be followed-up until progression. After this date, survival data will be collected.
Trial Details
NCT Number NCT03514368
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)
Solid Cancers
Enrollment 770 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov