EXL01 + Nivolumab and Ipilimumab

PRIMARY OBJECTIVE: I. To evaluate the effects of Faecalibacterium prausnitzii-containing bacterial strain formulation EXL01 (EXL01) (in combination with nivolumab/ipilimumab) on systemic immunomodulation in patients with mRCC. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of EXL01 (in combination with nivolumab/ipilimumab) in the treatment of patients with mRCC. II. To evaluate the effect of EXL01 on the clinical efficacy of nivolumab/ipilimumab.

EXPLORATORY OBJECTIVES: I. To determine the effect of EXL01 on gut microbiome diversity and function. II. To determine the effect of EXL01 on systemic immunodulation. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: CYCLES 1-4: Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle and receive EXL01 orally (PO) once daily (QD) on days 1-21 of each cycle.

This phase I trial tests the safety and effectiveness of nivolumab and ipilimumab with and without EXL01 for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.

EXL01 is a live biotherapeutic product containing a strain of bacteria called Faecalibacterium prausnitzii. It may enhance a patient's response to treatment with immune checkpoint inhibitors like nivolumab and ipilimumab by altering the composition of the bacteria in the gut. Adding EXL01 to treatment with nivolumab and ipilimumab may be safe and more effective than giving nivolumab and ipilimumab alone.

Live record on ClinicalTrials.gov →

• Documented informed consent of the participant and/or legally authorized representative
• Assent, when appropriate, will be obtained per institutional guidelines
• Agreement to allow the use of archival tissue from diagnostic tumor biopsies
• If unavailable, exceptions may be granted with study principal investigator (PI) approval
• Age: ≥ 18 years at time of signing informed consent
• Eastern Cooperative Oncology Group (ECOG) ≤ 2

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.