Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis
The clinical trial tests the use of over-the-counter probiotics VSL#3® 450B in patients receiving immunotherapy. Immunotherapy with monoclonal antibodies, helps the body's immune system attack tumor cells, and interferes with the ability of tumor cells to grow and spread. Immunotherapy can also cause an unfortunate side effect of inflammation of the colon and diarrhea, also known as immune checkpoint inhibitor induced colitis. Immune checkpoint inhibitor induced colitis can occur in up to 45% of patients receiving immunotherapy. Taking probiotics VSL#3® 450B may reduce the chances of developing immune checkpoint inhibitor induced colitis in patients receiving immunotherapy.
• Male or female age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Histologically confirmed solid malignancy
• Will be starting on ICIs or have started ≤ 2 cycles of ICIs
‣ For cohort 1: Ipilimumab with or without anti-PD-1/PD-L1 including but not limited to pembrolizumab, nivolumab, cemiplimab, atezolizumab, avelumab, or durvalumab
⁃ For cohort 2: Anti-PD-1/PD-L1 described above with or without chemotherapy
• Absolute neutrophil count (ANC) ≥ 1000/mm\^3
• Platelet count ≥ 75,000/mm\^3
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 2 x upper limit of normal (ULN)
• Serum glutamic-oxaloacetic transaminase (SGOT) \[aspartate transaminase (AST)\] ≤ 2 x ULN
• Albumin ≥ 3 g/dL
• Willing and able to provide research stool and blood samples
• Negative serum pregnancy test done ≤ 7 days prior to enrollment, for women of childbearing potential only
• Capable of providing valid informed consent
• Willing to return to enrolling institution for all study visits (blood draws, etc)