Phase 1 Study of CBM588 Capsules Combined With Nivolumab and Ipilimumab to Treat Advanced or Metastatic Kidney Cancer

What this Trial Is About

Researchers are evaluating the safety, side effects, best dose, and effectiveness of CBM588 capsules combined with nivolumab and ipilimumab in treating patients with advanced kidney cancer that has spread to nearby tissue, lymph nodes, or distant parts of the body. This phase I trial focuses on metastatic renal cell carcinoma, aiming to see how the combination affects the immune system and gut microbiome while monitoring tolerability and clinical benefits. Participants receive CBM588 capsules orally twice daily on days 1-21, along with nivolumab and ipilimumab given intravenously on day 1 of each 21-day cycle for four cycles. After this, they continue with CBM588 capsules twice daily on days 1-28 and nivolumab intravenously every 28 days if the disease does not progress or toxicity is unacceptable. The study includes dose escalation followed by dose expansion phases. Imaging scans like CT and bone scans are performed throughout, with optional MRI. During the study, participants provide blood samples and undergo various imaging tests to monitor disease and safety. Researchers assess dose-limiting toxicities, maximum tolerated dose, adverse events, progression-free survival, overall response rate, and changes in gut microbiome and metabolic pathways. Follow-up occurs once a year after treatment completion, with assessments continuing for up to three years to evaluate long-term safety and effects.

CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer