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A Study of SER-155 to Treat Diarrhea in People on Immunotherapy

ConditionsDiarrheaEnterocolitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Receipt of ICI (single-agent or combination) within the 180 days preceding screening.

Grade 2 - 3 diarrhea (i.e., increase of at least 4 bowel movements a day above baseline during the screening window), deemed by the treating provider as likely related to ICI therapy, with or without concomitant symptoms of grade 1 - 2 colitis (e.g.

Able to swallow oral medication

Disqualifiers

Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.

Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and/or infliximab, vedolizumab or ustekinumab

Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs

Admitted to the hospital for irEC

Trial design

Design model

Single group

Treatments tested in this trial

  • SER-155

    Biological/Vaccine

    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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Participants with Immune checkpoint inhibitor-related enterocolitis (irEC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion 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
2

Proportion of patients with treatment-related adverse events

Proportion of patients with treatment-related adverse events

Time frame
1 year

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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