Phase 1 Trial of Nivolumab and Ipilimumab With or Without EXL01 for Treating Advanced and Metastatic Renal Cell Cancer

What this Trial Is About

Researchers are evaluating the safety and effects of combining nivolumab and ipilimumab immunotherapy with or without a live biotherapeutic product called EXL01 for treating metastatic renal cell cancer. This phase 1 trial focuses on advanced kidney cancer that has spread to other parts of the body. EXL01 contains a strain of bacteria, Faecalibacterium prausnitzii, which may improve how the immune system responds to treatment by changing the gut microbiome. Participants are randomly assigned to one of two groups. In Arm A, patients receive nivolumab and ipilimumab intravenously for four 21-day cycles along with daily oral EXL01, followed by nivolumab and EXL01 given on a 28-day cycle. In Arm B, patients receive nivolumab and ipilimumab intravenously for four 21-day cycles, then nivolumab alone every 28 days. Treatment continues unless the disease progresses or side effects become unacceptable. Imaging scans such as CT, MRI, and bone scans are used to monitor disease status during treatment. Throughout the study, participants have blood samples collected regularly to assess immune responses and safety. After treatment ends, patients are followed up within 30 days and then every three months for up to two years. The main outcome measured is the change in a specific immune marker plasma IFN at baseline and week 13. Secondary outcomes include safety, tumor response, survival, and progression-free survival over two years.

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