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Probiotic

CBM588 + Nivolumab + Ipilimumab for Advanced Kidney Cancer

Phase 1

Recruiting

Led By Alex Chehrazi-Raffle

Research Sponsored by Osel, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) score must be ≤ 2

Must meet specified kidney function criteria

Must not have

Moderate to severe hepatic impairment

Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of using a probiotic called CBM588 in combination with two antibodies, nivolumab and ipilimumab, to treat patients with advanced kidney cancer

Who is the study for?

This trial is for patients with advanced kidney cancer that has spread. It's testing the safety and effectiveness of a new treatment combination.

What is being tested?

The trial examines CBM588, a probiotic, combined with two monoclonal antibodies, Nivolumab and Ipilimumab, to see if they can improve outcomes in advanced kidney cancer.

What are the potential side effects?

Potential side effects may include immune-related reactions due to Nivolumab and Ipilimumab, as well as digestive changes from the probiotic CBM588.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than 50% of my waking hours.

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My kidneys are functioning within the required range.

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I am not pregnant and can have children.

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I am 18 years old or older.

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My kidney cancer has been confirmed to have clear cell or sarcomatoid features.

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My kidney cancer is advanced or has spread and is not likely to respond well to treatment.

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My liver is functioning within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver is not working well.

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I have or had lung inflammation treated with steroids.

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I have recently undergone radiation therapy or treatment with radioactive substances.

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I am currently being treated for an infection.

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I have had a solid organ or bone marrow transplant.

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I do not have a history of serious heart conditions.

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I do not have any other active cancer.

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I do not have any recent serious illnesses that are not under control.

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I cannot swallow pills or receive treatments through IV.

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I require dialysis.

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I have been treated with ipilimumab or nivolumab before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicity (DLT)

Incidence of adverse events (AEs)

Maximum tolerated dose (MTD)

Secondary study objectives

Change in abundancies of gut microbiome species

Change in stool microbial diversity

Changes in serum short chain fatty acids

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CBM588 capsules, nivolumab, ipilimumab)Experimental Treatment7 Interventions

Patients receive CBM588 PO BID on days 1-21, nivolumab 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 CT, bone scan and blood sample collection throughout the study. Patients may optionally undergo MRI on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3420

Biospecimen Collection

2004

Completed Phase 3

~2030