RecruitingPhase 1NCT06399419

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

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


Sponsor

Osel, Inc.

Enrollment

28 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a probiotic capsule (CBM588, a beneficial gut bacteria supplement) to a standard immunotherapy combination (nivolumab and ipilimumab) improves outcomes for people with advanced kidney cancer. Researchers believe the gut microbiome may affect how well immunotherapy works. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced or metastatic kidney cancer (specifically clear cell or sarcomatoid type) - You have not previously received systemic (full-body) treatment for kidney cancer - Your cancer is classified as intermediate- or poor-risk - Your blood counts and organ function meet specific healthy thresholds **You may NOT be eligible if...** - You have previously received nivolumab or ipilimumab - You eat probiotic foods (yogurt, probiotic supplements) or plan to during treatment - You have active lung inflammation, autoimmune disease (with some exceptions), or serious infections - Cancer has spread to the brain (unless already treated and stable) - You are pregnant or breastfeeding - You cannot swallow capsules or receive IV infusions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

BIOLOGICALCBM588 Capsules

Given PO

PROCEDUREComputed Tomography

Undergo CT

BIOLOGICALIpilimumab

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALNivolumab

Given IV


Locations(1)

City of Hope Medical Center

Duarte, California, United States

View Full Details on ClinicalTrials.gov

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NCT06399419


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