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Tyrosine Kinase Inhibitor
CBM588 + Nivolumab + Cabozantinib 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
Absolute neutrophil count (ANC) >= 1500/uL without granulocyte colony-stimulating factor support (within 14 days before first dose of study treatment)
Karnofsky performance status >= 70%
Must not have
Active ILD/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids
Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects include typical reactions from immunotherapy like fatigue, skin issues, or inflammation in organs; digestive changes due to the probiotic; plus liver problems or high blood pressure from cabozantinib. Each patient may experience different side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My white blood cell count is healthy without needing medication.
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I am able to care for myself but may not be able to do active work.
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My kidney cancer cannot be cured with surgery or radiation and has spread.
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My white blood cell count is healthy without needing medication.
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I am not pregnant and cannot become pregnant.
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My kidney function, measured by creatinine levels or clearance, 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 and includes specific types.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had lung inflammation treated with steroids.
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I have no other active cancers or any diagnosed within the last 3 years needing treatment.
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I cannot swallow pills or receive treatments through an IV.
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I have been treated with cabozantinib before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 proportion of circulating myeloid-derived suppressor cells (MDSC)
Comparison of IL-6, IL-8 and other cytokines/chemokines
+4 moreAwards & Highlights
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 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clostridium butyricum CBM 588 Probiotic Strain
2019
Completed Phase 1
~30
Nivolumab
2014
Completed Phase 3
~5220
Cabozantinib S-malate
2013
Completed Phase 2
~470
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Renal Cell Carcinoma (RCC) include immune checkpoint inhibitors like nivolumab, which enhance the immune system's ability to target cancer cells, and tyrosine kinase inhibitors (TKIs) like cabozantinib, which block enzymes that promote tumor growth and angiogenesis. The trial involving CBM588, which restores beneficial Bifidobacterium species in the gut microbiome, suggests that microbiome modulation can potentially improve the efficacy of these treatments.
This multifaceted approach is important for RCC patients as it combines immune activation, inhibition of tumor growth pathways, and microbiome health to optimize treatment outcomes.
Stool Bacteriomic Profiling in Patients with Metastatic Renal Cell Carcinoma Receiving Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitors.Current management and future perspectives of metastatic renal cell carcinoma.The future of tyrosine kinase inhibitors: single agent or combination?
Stool Bacteriomic Profiling in Patients with Metastatic Renal Cell Carcinoma Receiving Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitors.Current management and future perspectives of metastatic renal cell carcinoma.The future of tyrosine kinase inhibitors: single agent or combination?
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
598 Previous Clinical Trials
1,923,345 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,879 Previous Clinical Trials
41,013,215 Total Patients Enrolled
Sumanta K PalPrincipal InvestigatorCity of Hope Medical Center
9 Previous Clinical Trials
322 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am able to care for myself but may not be able to do active work.My kidney cancer cannot be cured with surgery or radiation and has spread.My side effects from previous treatments are mild or back to normal.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.I am 18 years old or older.You are currently taking or planning to take probiotics, yogurt, or foods that have added bacteria during the treatment period.I have or had lung inflammation treated with steroids.You have had an allergic reaction to the study treatment before, or have a rare genetic condition that affects your ability to process certain sugars.I have no other active cancers or any diagnosed within the last 3 years needing treatment.I had one treatment before or after surgery for kidney cancer and my cancer returned 6 months after the last treatment.I agree to use birth control during and up to 7 months after the study.I haven't taken any kinase inhibitor medication in the last 2 weeks.I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.I do not have any severe illnesses that would make it unsafe for me to join the study.My white blood cell count is healthy without needing medication.I haven't had cancer treatment in the last 4 weeks.My side effects from previous treatments are mild or back to normal.I cannot swallow pills or receive treatments through an IV.I am not pregnant and cannot become pregnant.I am on certain blood thinners without major bleeding issues.My kidney function, measured by creatinine levels or clearance, is within the required range.People from any ethnic or racial background can participate.You have a disease that can be measured using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.My kidney cancer has spread to other parts of my body.I have not received a live vaccine in the last 30 days.My kidney cancer has been confirmed and includes specific types.I have been treated with cabozantinib before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (nivolumab, cabozantinib S-malate)
- Group 2: Arm 2 (CBM588, nivolumab, cabozantinib S-malate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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