RecruitingPhase IEN originalKidney cancerMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Potwierdzony rak nerki z przerzutami lub zaawansowany, niezdatny do operacji
  • Oczekiwana długość życia dłuższa niż 3 miesiące
  • Dobry stan ogólny (skala ECOG ≤ 2)
  • Norma krwi: wystarczająca liczba białych krwinek, płytek i hemoglobiny
  • Prawidłowe wyniki badań wątroby
  • Brak wcześniejszego leczenia systemowego raka nerki (z wyjątkami określonymi przez badaczy)
  • Możliwość zmierzenia wielkości guza w badaniach obrazowych

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 16, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (2)

City of Hope Medical Center

Duarte, United States

City of Hope Medical Center

Irvine, United States

Trial contact

Sumanta K. Pal

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/17/2026.

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