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SER-155 for the First-Line Treatment of Patients with Immunotherapy-Related Enterocolitis
Trial Status: active
This phase I trial studies the safety and effectiveness of SER-155 for the treatment of patients with immunotherapy-related enterocolitis who have not yet received treatment for their side effects. People treated with immunotherapy for their disease often develop immunotherapy-related enterocolitis, which is inflammation of the intestines that can cause diarrhea and abdominal pain. The standard of care treatment is usually corticosteroids for the first line of treatment or other medications that slow down the body’s immune response, however, these can be associated with side effects including serious or even fatal infections. Researchers are trying to shift away from these medications and focus more on evaluating the gut microbiome (microorganisms found in the gut). SER-155 is made from 16 different types of live bacteria that are naturally found in the gut of a healthy person. Upon administration, SER-155 may help restore a healthy balance of the bacteria in the gut microbiome by replacing the existing bacteria with a healthier population of bacteria, which could lead to improvements in immune system and gut health and may reduce side effects of immunotherapy-related enterocolitis.
Inclusion Criteria
Age >= 18 years
Receipt of immune checkpoint inhibitors (ICI) (single-agent or combination) within the 180 days preceding screening. Concurrent treatment with cytotoxic chemotherapy or other tumor-directed agents is permitted
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. abdominal pain, bloody or mucoid stools)
Able to swallow oral medication
Individuals of childbearing potential willing to use a highly effective method of contraception (failure rate of < 1% per year when used consistently and correctly) for 30 days after the last dose of SER-155
Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment
Exclusion Criteria
Active gastrointestinal (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
Prednisone (or steroid equivalent) dose > 10 mg a day for a non-GI irAE at time of screening
Pre-existing inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis) or microscopic colitis
Pregnant or lactating women
Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics
Severe neutropenia, as defined by an absolute neutrophil count (ANC) < 500 cells/mm^3, at time of screening
Treatment with investigational medications used for diarrhea/colitis treatment and microbiome therapeutics within 30 days prior to enrollment
Known allergy or intolerance to oral vancomycin
Unable to comply with the protocol requirements
Any condition that in the opinion of the investigator may increase the risk of study participation and/or may interfere with the interpretation of study results
Additional locations may be listed on ClinicalTrials.gov for NCT06801067.
I. To evaluate the safety and tolerability of microbiome SER-155 (SER-155) for treatment of immunotherapy-related enterocolitis (irEC).
SECONDARY OBJECTIVES:
I. To assess the preliminary efficacy of SER-155 in the treatment of patients with grade 2-3 diarrhea from irEC.
II. To assess the engraftment of SER-155 bacterial strains in the gastrointestinal microbiome of patients with irEC.
EXPLORATORY OBJECTIVES:
I. To assess the following in recipients of SER-155 with irEC:
Ia. Inflammatory markers;
Ib. Quality of life measures;
Ic. Immune correlatives;
Id. Fecal microbiome composition.
OUTLINE:
Patients receive vancomycin orally (PO) four times daily (QID) on days 1-2 and SER-155 PO once daily (QD) on days 3-14 in the absence of unacceptable toxicity. Additionally, patients undergo blood sample collection during screening and follow-up.
After completion of study treatment, patients are followed up for 166 days (days 15-180).
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
