Diarrhea, Enterocolitis
Conditions
Keywords
Diarrhea, SER-155, Enterocolitis, Memorial Sloan Kettering Cancer Center, 24-231
Brief summary
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.
Interventions
BIOLOGICALSER-155
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
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Receipt of 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with treatment-related adverse events of special interest | 1 year | Proportion of participants with treatment-related adverse events of special interest, i.e. blood stream infection |
| Proportion of patients with treatment-related adverse events | 1 year | Proportion of patients with treatment-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with immunosuppressive-free clinical remission of irEC at day 15 | 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 |
| Proportion of patients with immunosuppressive-free clinical response of irEC at day 43 | Day 43 | Proportion of patients with immunosuppressive-free clinical response of irEC at day 43 |
| Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43 | Day 43 | Proportion of patients with immunosuppressive-free clinical remission of irEC at day 43 |
| Number of detectable SER-155 strains at day 43 | Day 43 | Number of detectable SER-155 strains at day 43 |
| Time to immunosuppressive-free clinical remission | 1 year | Time to immunosuppressive-free clinical remission |
| Number of detectable SER-155 strains at day 15 | Day 15 | Number of detectable SER-155 strains at day 15 |
| Time to immunosuppressive-free clinical response | 1 year | Time to immunosuppressive-free clinical response |
| Proportion of patients with immunosuppressive-free clinical response of irEC (immunotherapy-related enterocolitis) at day 15 | 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 |
Countries
United States
Contacts
Primary ContactDavid Faleck, MD
Backup ContactMichael Postow, MD
Outcome results
None listed