Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients

Inclusion Criteria:

Diagnosis of any type of genitourinary, melanoma, lung, ovarian, uterine, cervical, and breast malignancies
Treatment with any ICPI agent(s)
Patients with new onset of ≥ grade 2 ICPI-induced diarrhea and/or colitis symptoms based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 45 days prior to date of FMT treatment without involvement of non- GI toxicity
No concern for active concomitant GI infection at the time of initiation of protocol therapy as confirmed by stool tests or as per the treating physician based on clinical presentation
Patient has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of protocol therapy
Ability to understand and willingness to sign an informed consent form
Life expectancy > 6 months

Exclusion Criteria

Age younger than 18 years
Patients with persistent GI infection confirmed with positive stool test(s) despite completing 5 days of antibiotics prior to initiation of protocol therapy
History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
Pregnant and breastfeeding women
Women who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was > 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there has been recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
Immunosuppressive treatment at onset of ICPI-induced diarrhea/colitis
Any medical conditions (e.g. severe heart failure, brain hemorrhage, septic shock, etc.) that are high risk for colonoscopy procedure by the assessment of the study PI or Co-PIs.
Patients who develop concurrent non-GI toxicity at the time of study treatment