A Randomized Study of Nivolumab and Ipilimumab With and Without EXL01 in First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC)
City of Hope Medical Center
Summary
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.
Description
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 e…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Life expectancy \> 3 months * Histologically confirmed renal cell carcinoma with clear cell renal cell carcinoma component with or wit…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureBone Scan
Undergo bone scan
- ProcedureComputed Tomography
Undergo CT
- Dietary SupplementFaecalibacterium prausnitzii-containing Bacterial Strain Formulation EXL01
Given PO
- BiologicalIpilimumab
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- BiologicalNivolumab
Locations (2)
- City of Hope Medical CenterDuarte, California
- City of Hope Medical CenterIrvine, California