NCT07037004

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

Impact of Microbiome Modulation With CBM588 in Combination With Pembrolizumab for Adjuvant Therapy of High-Risk, Resected Renal Cell Carcinoma (RCC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. Research has shown that changes to the composition of the healthy bacteria in the body (the microbiome), may improve a patient's response to treatment with immunotherapy. CBM588, a Live Biotherapeutic Product (LBP) containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with immunotherapy for other types of cancer. Adding CBM588 to treatment with pembrolizumab after surgery may cause changes in the microbiome that improve patient response to treatment and reduce disease recurrence, compared to pembrolizumab alone.

Detailed description

PRIMARY OBJECTIVE: I. To determine if the Clostridium butyricum CBM588 strain (CBM588) increases interleukin (IL)-12 production in patients with high-risk, resected renal cell carcinoma (RCC) receiving pembrolizumab. SECONDARY OBJECTIVES: I. To determine if CBM588 improves recurrence-free survival (RFS) in patients with high-risk, resected renal cell carcinoma (RCC) receiving pembrolizumab. II. To determine if CBM588 improves overall survival (OS) in patients with high-risk, resected renal cell carcinoma (RCC) receiving pembrolizumab. III. To characterize global changes in stool microbiome profile in patients with high-risk, resected RCC receiving pembrolizumab with or without CBM588. IV. To characterize changes in circulating cytokine and immune cell populations in patients with high-risk, resected RCC receiving pembrolizumab with or without CBM588. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive CBM588 orally (PO) twice daily (BID) on days 1-21 or days 1-42 of each cycle and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and computed tomography (CT) throughout the study. ARM 2: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT throughout the study. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Clear Cell Renal Cell Carcinoma
• Sarcomatoid Renal Cell Carcinoma
• Stage II Renal Cell Cancer AJCC v8
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
DRUG	Clostridium butyricum CBM588 Strain	Given PO
PROCEDURE	Computed Tomography	Undergo CT
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2026-05-04
• Primary completion: 2027-05-04
• Completion: 2027-05-04
• First posted: 2025-06-25
• Last updated: 2025-09-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study