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.
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Cumulative relative abundance of immunotherapy-responsiveness associated species at day 12 of MET-4
Timeframe: Approximately 12 days
Changes in relative abundance of immunotherapy-responsiveness associated MET-4 strains between baseline and approximately day 12
Timeframe: Approximately 12 days
Number of participants with treatment-related adverse events assessed by CTCAE v.5.0
Timeframe: 2 years