Preventing Toxicity in Renal Cancer Patients Treated With Immunotherapy Using Fecal Microbiota Transplantation

Exclusion Criteria

• •Prior systemic therapy for unresectable locally advanced or metastatic RCC including investigational agents.
• •Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with signing the informed consent through 6 months after FMT.
• •Diagnosis of immunodeficiency (e.g. HIV, transplantation)
• •Receiving systemic steroid therapy (\>10mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment. Adrenal replacement steroids doses \> 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic steroids for allergic situations (e.g. contrast allergy) is also permitted. Patients who require inhaled, intranasal, intra-articular, or topical steroids are allowed. Intermittent use of bronchodilators or local steroid injections are not excluded from the study
• •Ongoing use of antibiotics or previous use of antibiotics in the last two weeks prior to the initial FMT procedure
• •Presence of a chronic intestinal disease (e.g. Celiac, malabsorption, colonic tumor)
• •Presence of absolute contra-indications to FMT administration
• •* Toxic megacolon
• •* Severe dietary allergies (e.g. shellfish, nuts, seafood)
• •* Inflammatory bowel disease
• •Expected to require any other form of systemic or localized anti-neoplastic therapy while on study. Treatment with either bisphosphonate or denosumab for bone metastatic disease is allowed
• •Known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for five years
• •o NOTE: This time requirement also does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers.
• •Active central nervous system (CNS) metastases and/or leptomeningeal involvement, unless treated with radiotherapy and/or radiosurgery with stable disease for at least 4 weeks prior to study entry after radiotherapy or at least 8 weeks prior to study entry after major surgery
• •Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents.
• •o Patients with vitiligo, type I diabetes, resolved childhood asthma/atopy are exceptions to this rule
• •A history of (non-infectious) pneumonitis that required steroids or current pneumonitis
• •Serious concomitant illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders
• •o This includes HIV or AIDS-related illness, or active HBV and HCV
• •Active infection requiring systemic therapy.
• •Patient has received a live vaccine within 4 weeks prior to the first dose of treatment
• •o Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
• •Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial