RecruitingPhase 1NCT07128680

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)


Sponsor

City of Hope Medical Center

Enrollment

33 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a live biotherapeutic product (EXL01 — a gut bacteria treatment) to standard immunotherapy (nivolumab and ipilimumab) improves outcomes for people with advanced kidney cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced or metastatic clear cell renal cell carcinoma (a type of kidney cancer) - You have not received prior immunotherapy for your cancer - Your overall health status is adequate (ECOG score of 0–2) - Your life expectancy is more than 3 months **You may NOT be eligible if...** - You have previously received immunotherapy (anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.) - You are currently using probiotics, herbal supplements, or have had a fecal transplant recently - You have an active autoimmune disease - You have a history of severe immune-related side effects from prior medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Given IV


Locations(2)

City of Hope Medical Center

Duarte, California, United States

City of Hope Medical Center

Irvine, California, United States

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NCT07128680


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