Actively Recruiting
A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-02
15
Participants Needed
7
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SER-155 to Treat Diarrhea in People on Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Received immune checkpoint inhibitor treatment within 180 days before screening
- Grade 2 to 3 diarrhea likely related to immunotherapy, with or without mild colitis symptoms
- Able to swallow oral medication
- Willing to use effective contraception if of childbearing potential for 30 days after last dose of SER-155
- Provide written informed consent and comply with study procedures
You will not qualify if you...
- Active gastrointestinal infection causing diarrhea
- Received immunosuppressive therapy for irEC, including corticosteroids or specific biologics
- Severe colitis symptoms such as severe abdominal pain or peritoneal signs
- Hospitalized for immunotherapy-related enterocolitis
- Taking prednisone over 10 mg daily for non-gastrointestinal immune side effects at screening
- Pre-existing inflammatory bowel diseases or microscopic colitis
- Pregnant or breastfeeding
- Require ongoing antibacterial antibiotics
- Severe neutropenia (ANC < 500 cells/mm³) at screening
- Use of investigational diarrhea or microbiome treatments within 30 days prior to enrollment
- Known allergy or intolerance to oral vancomycin
- Unable to follow study protocol
- Any condition that may increase risk or interfere with study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
D
David Faleck, MD
CONTACT
M
Michael Postow, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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