NCT07128680

Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer

A Randomized Study of Nivolumab and Ipilimumab With and Without EXL01 in First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 5+: Patients continue receiving nivolumab IV over 30 minutes on day 1 of each cycle and EXL01 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and collection of blood samples throughout the study. Patients may undergo magnetic resonance imaging (MRI) at screening and may undergo bone scan as clinically indicated. ARM B: CYCLES 1-4: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 5+: Patients continue receiving nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and collection of blood samples throughout the study. Patients may undergo MRI at screening and may undergo bone scan as clinically indicated. After completion of study treatment, patients are followed up within 30 days then every 3 months for up to 2 years.

Conditions

• Advanced Clear Cell Renal Cell Carcinoma
• Advanced Sarcomatoid Renal Cell Carcinoma
• Metastatic Clear Cell Renal Cell Carcinoma
• Metastatic Sarcomatoid Renal Cell Carcinoma
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
PROCEDURE	Bone Scan	Undergo bone scan
PROCEDURE	Computed Tomography	Undergo CT
DIETARY_SUPPLEMENT	Faecalibacterium prausnitzii-containing Bacterial Strain Formulation EXL01	Given PO
BIOLOGICAL	Ipilimumab	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-08-25
• Completion: 2028-08-25
• First posted: 2025-08-19
• Last updated: 2026-02-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study