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Checkpoint Inhibitor

CBM588 + Immunotherapy for Kidney Cancer

Phase 1

Waitlist Available

Led By Sumanta K Pal

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

ECOG performance status < 2

Intermediate or poor risk disease by IMDC classification

Must not have

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

Women who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy drugs with a probiotic to see if it is more effective in treating kidney cancer than immunotherapy alone.

Who is the study for?

This trial is for adults with advanced kidney cancer (stage IV) who haven't had systemic therapy, except under certain conditions. Participants should have a performance status indicating they can carry out daily activities with minimal assistance and must not be pregnant or breastfeeding. They cannot join if they have untreated brain metastases, are on immunosuppressive drugs, or have had recent heart issues.

What is being tested?

The study tests the combination of CBM588 probiotic strain with nivolumab and ipilimumab immunotherapies in patients with stage IV kidney cancer. The goal is to see if this probiotic can boost the effectiveness of these immune system-targeting antibodies that may prevent tumor growth and spread.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs, skin rash, fatigue, digestive problems like diarrhea or colitis, liver enzyme elevation suggesting liver inflammation, hormonal gland issues like thyroid dysfunction, and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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I can do most of my daily activities without help.

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My condition is classified as intermediate or poor risk.

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I haven't had systemic therapy for kidney cancer, except under certain conditions.

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My kidney function is within the required range.

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My kidney cancer has spread to other parts of my body.

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

Exclusion Criteria

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

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I have or had lung inflammation treated with steroids.

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I am not pregnant or breastfeeding.

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I have brain metastases that have not been treated.

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I have an autoimmune disease and take steroids or immunosuppressants.

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My adrenal glands are not working properly and it's not under control.

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My kidney function is reduced, with low creatinine clearance or high serum creatinine.

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I have been treated with drugs that target the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Change in Bifidobacterium composition of stool

Secondary study objectives

Best overall response

Change in Shannon index

Progression-free survival (PFS)

Other study objectives

Change in IL-6, IL-8, and other cytokines/chemokines levels

Change in proportion of circulating myeloid-derived suppressor cells (MDSCs)

Body Weight Changes

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (CBM588, nivolumab, ipilimumab)Experimental Treatment3 Interventions

Patients receive clostridium butyricum CBM 588 probiotic strain PO BID, nivolumab IV over 30 minutes on day 1, and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 5, treatment with clostridium butyricum CBM 588 probiotic strain and nivolumab repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (nivolumab, ipilimumab)Active Control2 Interventions

Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 5, patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

FDA approved

Nivolumab

FDA approved

Clostridium butyricum CBM 588 Probiotic Strain

2019

Completed Phase 1

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