Trial Summary
What is the purpose of this trial?
This trial is testing a special bacteria (CBM588) with two cancer drugs in patients with advanced kidney cancer. The bacteria might help the drugs work better by changing gut bacteria. The drugs help the immune system fight cancer and stop cancer growth.
Eligibility Criteria
Adults with advanced or metastatic kidney cancer who haven't had systemic therapy for it, except possibly one prior treatment if the cancer came back after at least 6 months. They should have a certain level of blood cells and organ function, not be pregnant, agree to use contraception, and can't have severe illnesses that would make the trial unsafe for them.Inclusion Criteria
I have had only one prior treatment for kidney cancer, and if it came back, it was 6 months after treatment ended.
My white blood cell count is healthy without needing medication.
Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
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Exclusion Criteria
My heart's electrical activity (QTcF) is over 500 ms, or I have risk factors for a specific heart rhythm problem.
My brain metastases are stable and treated, with no changes for 4 weeks.
You are currently taking or planning to take probiotics, yogurt, or foods that have added bacteria during the treatment period.
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Treatment Details
Interventions
- Cabozantinib S-malate (Tyrosine Kinase Inhibitor)
- Clostridium butyricum CBM 588 Probiotic Strain (Probiotic Strain)
- Nivolumab (Checkpoint Inhibitor)
Trial OverviewThe trial is testing CBM588 (a probiotic strain) combined with nivolumab (an immune system booster) and cabozantinib (a cell growth blocker), to see if they work better together against kidney cancer that has spread. It's in phase I to check how this combo affects patients' gut bacteria and their response to treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 (CBM588, nivolumab, cabozantinib S-malate)Experimental Treatment3 Interventions
Patients receive CBM588 PO BID, nivolumab IV over 30 minutes on day 1, and cabozantinib S-malate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (nivolumab, cabozantinib S-malate)Active Control2 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cabozantinib S-malate is already approved in United States, United States, European Union for the following indications:
🇺🇸 Approved in United States as Cabometyx for:
- Advanced renal cell carcinoma (RCC)
- Hepatocellular carcinoma (HCC)
- Locally advanced or metastatic differentiated thyroid cancer (DTC)
🇺🇸 Approved in United States as Cometriq for:
- Medullary thyroid cancer
🇪🇺 Approved in European Union as Cabometyx for:
- Advanced renal cell carcinoma (RCC)
- Hepatocellular carcinoma (HCC)
- Locally advanced or metastatic differentiated thyroid cancer (DTC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
City of Hope Medical CenterDuarte, CA
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Who Is Running the Clinical Trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator