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

Metastatic Renal Cell Carcinoma Clinical Trial

Official title: An Open-Label, Phase I, Dose-Finding Study of CBM588 in Combination With Nivolumab/Ipilimumab for Patients With Advanced Stage Renal Cell Carcinoma

Status Recruiting

Clinical Trial Summary

This phase I trial tests the safety, side effects, best dose, and effectiveness of CBM588 in combination with nivolumab and ipilimumab in treating patients with kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). CBM588 is a live biotherapeutic that may help improve the effects of immunotherapy. Nivolumab and ipilimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread by enhancing the ability of the body's immune cells to attack tumor cells. CBM588 in combination with nivolumab and ipilimumab may be safe, tolerable, and/or effective in treating patients with advanced stage kidney cancer.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To evaluate the safety and tolerability of nivolumab/ipilimumab with escalating doses of Clostridium butyricum MIYAIRI 588 capsules (CBM588) in patients with metastatic renal cell carcinoma.

SECONDARY OBJECTIVES:

I. To evaluate the effect of CBM588 on the clinical efficacy of nivolumab/ipilimumab.

II. To determine the effect of CBM588 (in combination with nivolumab/ipilimumab) in modulation of the gut microbiome in patients with metastatic renal cell carcinoma.

III. To assess the effect of CBM588 on the change of metabolic pathways with the nivolumab/ipilimumab combination in patients with metastatic renal cell carcinoma.

IV. To determine the effect of CBM588 on systemic immunomodulation.

OUTLINE: This is a dose-escalation study of CBM588 followed by a dose-expansion study.

Patients receive CBM588 capsules orally (PO) twice daily (BID) on days 1-21, nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 4 cycles. Patients then receive CBM588 PO BID on days 1-28 and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT), bone scan and blood sample collection throughout the study. Patients may optionally undergo magnetic resonance imaging (MRI) on study.

After completion of study treatment, patients are followed up once a year. ;

Related Conditions & MeSH terms

• Advanced Clear Cell Renal Cell Carcinoma
• Advanced Renal Cell Carcinoma
• Advanced Sarcomatoid Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Clear Cell Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma
• Metastatic Sarcomatoid Renal Cell Carcinoma
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

• NCT number: NCT06399419
• Study type: Interventional
• Source: Osel, Inc.
• Status: Recruiting
• Phase: Phase 1
• Start date: June 19, 2024
• Completion date: October 19, 2026