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Study identifier: NCT07128680 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Advanced Clear Cell Renal Cell Carcinoma · Advanced Sarcomatoid Renal Cell Carcinoma · Metastatic Clear Cell Renal Cell Carcinoma  ·  Sponsor: City of Hope Medical Center

PhasePhase 1
Planned participants33
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (2)

City of Hope Medical CenterDuarte, California, United StatesRecruiting
City of Hope Medical CenterIrvine, California, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07128680