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

  • End date
    Nov 23, 2028
  • participants needed
  • sponsor
    Lawson Health Research Institute
Updated on 23 April 2022
platelet count
karnofsky performance status
gilbert's syndrome
neutrophil count
curative surgery
kidney cancer


Cancer immunotherapy has been largely adopted in oncology patient management in the last decade. The deep and long responses to immunotherapy have accelerated the approval of these drugs across multiple disease sites. However, these agents can also be toxic to patients, meaning, the patient will have to discontinue treatment and outcomes could be negatively affected. Recently, a combination of two immunotherapy drugs, ipilimumab and nivolumab (ipi/nivo), has been approved for the treatment of intermediate and poor-risk renal cell carcinoma (RCC) patients. This powerful combination provides survival benefit, however, it can also be highly toxic leading to discontinuation of this treatment.

There has been some evidence that these otherwise toxic drugs can be better tolerated by altering the composition of the patients gut bacteria to create a more diverse and healthy microbiome. The current study will involve Fecal Microbiota Transplantation (FMT) before the start of the immunotherapy combination, and during the first two cycles of ipilimumab treatment (the more toxic agent) as supportive therapy to prevent toxicity associated with the ipi/nivo combination.

The goal of this project is to study the safety of such FMT combination treatment and reduce occurrence of immune-related toxicities in patients, allowing them to continue their cancer treatments in the hopes of a better outcome. The investigators will also be looking at changes in the immune populations, microbiome profile of patients, response to treatment, and patient survival as secondary objectives.

Condition Renal Cell Carcinoma
Treatment Fecal Microbiota Transplantation
Clinical Study IdentifierNCT04163289
SponsorLawson Health Research Institute
Last Modified on23 April 2022


Yes No Not Sure

Inclusion Criteria

Patients must have histologically confirmed diagnosis of advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma
Intermediate or poor risk RCC as defined by International Metastatic RCC Database Consortium (IMDC criteria, Heng et al 2009)
Karnofsky performance status (KPS) < 80%
Less than 1 year form initial RCC diagnosis (including original localized disease if applicable) to systemic treatment
Hemoglobin < lower limit of normal (LLN)
Corrected calcium > 10 mg/dL
Absolute neutrophil count (ANC) > upper limit of normal (ULN)
Platelet count > ULN
Age ≥ 18 years
Karnofsky Performance Status (KPS) ≥70%
Evaluable disease determined by the Investigator
Ability to ingest capsules
Able to provide written informed consent
Understand non-infectious risks associated with FMT administration and that the long term data regarding safety risks of FMT are lacking
Recovery to baseline or ≤ Grade 1 CTCAE v 4.0 from toxicities related to any prior treatments, unless AEs are clinically non-significant
Adequate organ and marrow function, based upon meeting all the following laboratory
Absolute neutrophil count (ANC) ≥ 1500/μL (≥ 1.5 x 109/L) without granulocyte colony-stimulating factor support within 4 weeks before screening laboratory sample collection
White blood cell count ≥ 2000/μL (≥ 2.0 x 109/L)
Platelets ≥ 100,000/μL (≥ 100 x 109/L) without transfusion within 4 weeks before screening laboratory sample collection
Hemoglobin ≥ 9 g/dL (≥ 90 g/L) without transfusion within 4 weeks before screening laboratory sample collection
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN
Total bilirubin ≤ 1.5 × ULN (with the exception that total bilirubin for subjects with Gilbert's disease ≤ 3 × ULN)
Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 40 mL/min (≥ 0.67 mL/sec) using the Cockcroft-Gault equation (see for Cockcroft-Gault formula)
Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g

Exclusion Criteria

Prior systemic therapy for unresectable locally advanced or metastatic RCC including investigational agents
Radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to study entry. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible for the study
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
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
metastatic disease is allowed
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 autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Active central nervous system (CNS) metastases and/or leptomeningeal involvement
Patients with vitiligo, type I diabetes, resolved childhood asthma/atopy are exceptions to this rule
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
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
This includes HIV or AIDS-related illness, or active HBV and HCV
prior to study entry after major surgery
Active infection requiring systemic therapy
Patient has received a live vaccine within 4 weeks prior to the first dose of treatment
A history of (non-infectious) pneumonitis that required steroids or current
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
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