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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a bacteria, CBM588, to see if it can restore a good bacteria in the gut that might help standard therapies work better in treating patients with kidney cancer that has spread.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Bifidobacterium composition of stool
Secondary outcome measures
Best overall response
Change in proportion of circulating myeloid-derived suppressor cells (MDSC)
Comparison of IL-6, IL-8 and other cytokines/chemokines
+4 moreTrial 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
Nivolumab
2014
Completed Phase 3
~4750
Cabozantinib S-malate
2013
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,429 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,122 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of participants in this experiment?
"Affirmative. Documentation hosted on clinicaltrials.gov confirms that this research, which was first published in November 1st 2021, is actively enrolling people into the study. Currently 30 participants are needed from a single medical centre."
Answered by AI
Is this endeavor an unprecedented investigation?
"Clostridium butyricum CBM 588 Probiotic Strain is being tested in 793 separate trials across 2553 cities and 53 countries. The first trial, sponsored by Exelixis, launched back in 2012 with 86 participants and finished its Phase 2 approvals stage. Since then, 305 other studies have reached completion."
Answered by AI
Is enrollment still open for this experiment?
"Affirmative. Clinicaltrials.gov is hosting data which evidences that this clinical trial, posted on November 1st 2021, is actively searching for participants. Thus far, 30 patients have been recruited from a single medical centre."
Answered by AI
Has the Clostridium butyricum CBM 588 Probiotic Strain been examined in additional research?
"Currently, 90 Phase 3 trials are being conducted worldwide to study the effects of Clostridium butyricum CBM 588 Probiotic Strain. Most notably, Basel, BE is hosting 793 active studies on this strain while 43550 locations across the globe have joined in these investigations."
Answered by AI
Does the Clostridium butyricum CBM 588 Probiotic Strain pose any potential risks to human health?
"The profile of safety for Clostridium butyricum CBM 588 Probiotic Strain concluded with a score of 1 due to the fact that this is an initial-phase trial, and there is scant evidence on both its efficacy and security."
Answered by AI
How is Clostridium butyricum CBM 588 Probiotic Strain typically utilized?
"The Clostridium butyricum CBM 588 Probiotic Strain is approved to treat malignant neoplasms. It has also been used as a therapy for conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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