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Feasibility Study of MET-4: Evaluating Fecal Microbiome Effects in Immunotherapy Patients

Study acronym: MET4-IO
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 13 words Secondary endpoints: details revised at 2 of 3 entries Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Completion date: Dec 1, 2025 to Dec 1, 2026v10
  3. Study title shortened, about 6 wordsv9 See this version in full on ClinicalTrials.gov ↗
  4. Re-verified, no change to tracked fieldsv8
  5. Phase: Early Phase 1 to Phase 2/3 Primary completion date: Dec 1, 2023 to Dec 1, 2024 · Trial status: Recruiting to Active, Not Recruiting · Completion date: Dec 1, 2023 to Dec 1, 2025 · 2 morev7 Show 5 more changesShow less
    • Primary completion date: Dec 1, 2023 to Dec 1, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Dec 1, 2023 to Dec 1, 2025
    • Site details revised
    • Study arms: 3 to 4
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Aug 1, 2021 to Dec 1, 2023v6
  2. Primary completion date: Dec 1, 2020 to Aug 1, 2021v5
  3. Trial status: Active, Not Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  4. Trial status: Recruiting to Active, Not Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 1, 2018 to Nov 30, 2018v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 1, 2018 to Nov 30, 2018
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is designed to assess the safety, tolerability and engraftment (cumulative relative abundance) of MET-4 strains when given in combination with immune checkpoint inhibitors (ICIs). There will be a safety cohort (group A) of 5 subjects which will receive MET-4 in addition to standard of care (SOC) ICI. After the safety cohort, 40 patients will be enrolled in group B which will be randomized to MET4 with SOC ICI vs. control group with SOC ICI only. Group C will enroll 20 patients who have already started on SOC ICI and have had first unconfirmed progression of disease and expected to continue with standard ICI treatment. These patients will be randomized to continue receiving standard ICI alone, or SOC ICI with MET4.
Trial Details
NCT Number NCT03686202
Lead Sponsor University Health Network, Toronto
Collaborators: NuBiyota
Conditions All Solid Tumors
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov