The purpose of this study is to find out whether SER-155 may be a safe first treatment that causes few or mild side effects for people due to irEC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
SER-155 (Cultivated Multi-Strain Live Bacterial Therapeutic, Encapsulated) is an experimental designed ecology of 16 unique, human-commensal bacterial strains encapsulated for oral administration and will be provided by Seres as an investigational drug
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
RECRUITINGProportion of participants with treatment-related adverse events of special interest
Proportion of participants with treatment-related adverse events of special interest, i.e. blood stream infection
Time frame: 1 year
Proportion of patients with treatment-related adverse events
Proportion of patients with treatment-related adverse events
Time frame: 1 year
Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15
Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15, defined as at least one grade decrease in diarrhea symptoms without the use of immunosuppressive therapy
Time frame: Day 15
Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15
Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15, defined as resolution in diarrhea symptoms (grade 0) without the use of immunosuppressive therapy
Time frame: Day 15
Proportion of patients with immunosuppressive-free clinical response of irEC at day 43
Proportion of patients with immunosuppressive-free clinical response of irEC at day 43
Time frame: Day 43
Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43
Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43
Time frame: Day 43
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Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States
RECRUITINGTime to immunosuppressive-free clinical response
Time to immunosuppressive-free clinical response
Time frame: 1 year
Time to immunosuppressive-free clinical remission
Time to immunosuppressive-free clinical remission
Time frame: 1 year
Number of detectable SER-155 strains at day 15
Number of detectable SER-155 strains at day 15
Time frame: Day 15
Number of detectable SER-155 strains at day 43
Number of detectable SER-155 strains at day 43
Time frame: Day 43