Effect of Adding CBM588 to Pembrolizumab on Preventing Recurrence in High-Risk Renal Cell Cancer After Surgery

What this Trial Is About

Researchers are evaluating the effect of adding a live biotherapeutic product called CBM588 to pembrolizumab compared to pembrolizumab alone in preventing the return of renal cell cancer after surgery. Pembrolizumab is an immune checkpoint inhibitor used after surgery for renal cell cancer. This phase II trial investigates whether changes to the bodys microbiome caused by CBM588 can improve response to immunotherapy and reduce cancer recurrence. Participants are randomly assigned to one of two groups. One group receives CBM588 orally twice daily on days 1-21 or 1-42 of each treatment cycle along with pembrolizumab given intravenously on day 1 of each cycle. The other group receives pembrolizumab alone intravenously on day 1 of each cycle. Treatment cycles repeat every 21 or 42 days for up to 12 months unless disease worsens or unacceptable side effects occur. Blood samples and computed tomography scans are collected throughout the study. During the trial, participants will undergo regular imaging and blood tests to monitor immune and microbiome changes. Researchers will measure changes in interleukin-12 levels, recurrence-free survival, overall survival, stool microbiome diversity, immune cell populations, and cytokines. Safety is monitored up to 30 days after the last dose. After completing treatment, participants have a follow-up visit at 30 days. The study is expected to continue until October 2028.

Adding a Live Biotherapeutic Product (CBM588) to Pembrolizumab for the Treatment of Renal Cell Cancer After Surgery