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Checkpoint Inhibitor

CBM588 + Immunotherapy for Kidney Cancer

Q: How many participants are being administered treatment in this clinical trial?

This particular trial is no longer seeking participants, with its last update occurring on October 12th 2022. However, 2584 studies are recruiting patients dealing with clear cell <a href="https://www.withpower.com/clinical-trials/renal-cell-carcinoma">renal cell carcinoma</a> (ccrcc), and an additional 764 trials are actively accepting enrollees for Clostridium butyricum CBM 588 Probiotic Strain research.

Q: Are there any prior experiments involving Clostridium butyricum CBM 588 Probiotic Strain?

Currently, 86 Phase 3 clinical trials of Clostridium butyricum CBM 588 Probiotic Strain are active with 764 taking place globally. Pittsburgh is a major hub for this study, yet there are 42760 sites in total where these studies take place.

Q: In what conditions has Clostridium butyricum CBM 588 Probiotic Strain been found to be efficacious?

Clinicians often prescribe Clostridium Butyricum CBM 588 to patients who have already undergone anti-angiogenic therapies. Moreover, this probiotic strain can be used to combat a variety of illnesses including <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a> and other malignant neoplasms.

Q: Is the Clostridium butyricum CBM 588 Probiotic Strain compliant with FDA regulations?

With limited clinical data supporting both safety and efficacy, the probiotic strain of Clostridium butyricum CBM 588 has a score of 1.

Q: Are there still vacancies in this research endeavor for participants?

As per the information present on clinicaltrials.gov, this particular trial has concluded recruitment and is no longer enrolling patients; it was initially posted on May 14th 2019 before being modified lastly on October 12th 2021. However, there are still 3348 other experiments actively seeking participants now.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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 Shannon index

Progression-free survival (PFS)

Other outcome measures

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

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,341 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

569 Previous Clinical Trials

1,924,658 Total Patients Enrolled

Sumanta K PalPrincipal InvestigatorCity of Hope Medical Center

9 Previous Clinical Trials

323 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being administered treatment in this clinical trial?

"This particular trial is no longer seeking participants, with its last update occurring on October 12th 2022. However, 2584 studies are recruiting patients dealing with clear cell renal cell carcinoma (ccrcc), and an additional 764 trials are actively accepting enrollees for Clostridium butyricum CBM 588 Probiotic Strain research."

Answered by AI

Are there any prior experiments involving Clostridium butyricum CBM 588 Probiotic Strain?

"Currently, 86 Phase 3 clinical trials of Clostridium butyricum CBM 588 Probiotic Strain are active with 764 taking place globally. Pittsburgh is a major hub for this study, yet there are 42760 sites in total where these studies take place."

Answered by AI

In what conditions has Clostridium butyricum CBM 588 Probiotic Strain been found to be efficacious?

"Clinicians often prescribe Clostridium Butyricum CBM 588 to patients who have already undergone anti-angiogenic therapies. Moreover, this probiotic strain can be used to combat a variety of illnesses including melanoma, squamous cell carcinoma and other malignant neoplasms."

Answered by AI

Is the Clostridium butyricum CBM 588 Probiotic Strain compliant with FDA regulations?

"With limited clinical data supporting both safety and efficacy, the probiotic strain of Clostridium butyricum CBM 588 has a score of 1."

Answered by AI

Are there still vacancies in this research endeavor for participants?

"As per the information present on clinicaltrials.gov, this particular trial has concluded recruitment and is no longer enrolling patients; it was initially posted on May 14th 2019 before being modified lastly on October 12th 2021. However, there are still 3348 other experiments actively seeking participants now."

Answered by AI

Recent research and studies

Nature MedicineJournal

Nivolumab Plus Ipilimumab with or Without Live Bacterial Supplementation in Metastatic Renal Cell Carcinoma: A Randomized Phase 1 Trial

Dizman, Nazli, Luis Meza, Paulo Bergerot, Marice Alcantara, Tanya Dorff, Yung Lyou, Paul Frankel, et al.. 2022. “Nivolumab Plus Ipilimumab with or Without Live Bacterial Supplementation in Metastatic Renal Cell Carcinoma: A Randomized Phase 1 Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-022-01694-6.

clinicaltrials.govStudy

CBM588, Nivolumab, and Ipilimumab in Treating Patients With Stage IV or Advanced Kidney Cancer

2019. "CBM588, Nivolumab, and Ipilimumab in Treating Patients With Stage IV or Advanced Kidney Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03829111.

All > Kidney Cancer