CBM588 + Immunotherapy for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen BySumanta K Pal

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I trial studies how well CBM588 works when given together with nivolumab and ipilimumab in treating patients with kidney cancer that is stage IV or has spread to other places in the body (advanced). CBM588 is a probiotic that may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CBM588, nivolumab, and ipilimumab may work better in treating patients with kidney cancer.

Eligibility Criteria

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.

Inclusion Criteria

I can do most of my daily activities without help.

My condition is classified as intermediate or poor risk.

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

My kidney function is within the required range.

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

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

Exclusion Criteria

I have or had lung inflammation treated with steroids.

I am not pregnant or breastfeeding.

I have brain metastases that have not been treated.

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

I have an autoimmune disease and take steroids or immunosuppressants.

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

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

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

Participant Groups

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.

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.

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for: