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

Inclusion Criteria

• Diagnosis of any type of genitourinary (kidney, bladder and prostate), melanoma, non-melanoma skin cancer, lung, head & neck, sarcoma/lymphoma, gastrointestinal system (luminal gastrointestinal [GI], hepatobiliary, pancreas), gynecology system (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
• Patients with a history of steroid use before FMT can be allowed if last dose was > 30 days prior to FMT treatment or treatment duration was for < 7 days beyond one week prior to FMT treatment
• Patients with a history of immunosuppressant (infliximab, vedolizumab etc) use before FMT can be allowed if last dose was administered >= 3 months prior to FMT treatment when used for the treatment of conditions other than for ICI- induced GI toxicities (e.g., infliximab is used in the treatment of Crohn’s disease, rheumatoid arthritis, plaque psoriasis, and vedolizumab is used in treating ulcerative colitis)
• 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 Bacillus Calmette-Guerin [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
• 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 primary investigator (PI) or Co-PIs
• 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
• Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire