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Probiotic

Treatment (CBM588, nivolumab, ipilimumab) for Kidney Cancer

Phase 1

Recruiting

Led By Alex Chehrazi-Raffle

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

Eastern Cooperative Oncology Group (ECOG) score must be ≤ 2

Must meet specified kidney function criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of using a probiotic called CBM588 in combination with two antibodies, nivolumab and ipilimumab, to treat patients with advanced kidney cancer

Who is the study for?

This trial is for patients with advanced kidney cancer that has spread. It's testing the safety and effectiveness of a new treatment combination.Check my eligibility

What is being tested?

The trial examines CBM588, a probiotic, combined with two monoclonal antibodies, Nivolumab and Ipilimumab, to see if they can improve outcomes in advanced kidney cancer.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions due to Nivolumab and Ipilimumab, as well as digestive changes from the probiotic CBM588.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than 50% of my waking hours.

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My kidneys are functioning within the required range.

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I am not pregnant and can have children.

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I am 18 years old or older.

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

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My kidney cancer is advanced or has spread and is not likely to respond well to treatment.

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My liver is functioning within normal ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Dose limiting toxicity (DLT)

Incidence of adverse events (AEs)

Maximum tolerated dose (MTD)

Secondary outcome measures

Change in abundancies of gut microbiome species

Change in stool microbial diversity

Changes in serum short chain fatty acids

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CBM588, nivolumab, ipilimumab)Experimental Treatment7 Interventions

Patients receive CBM588 PO BID on days 1-21, nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 4 cycles. Patients then receive CBM588 PO BID on days 1-28 and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT, bone scan and blood sample collection throughout the study. Patients may optionally undergo MRI on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Bone Scan

2015

Completed Phase 2

~50

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

Biospecimen Collection

2004

Completed Phase 2

~1720

Computed Tomography

2017

Completed Phase 2

~2720

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

570 Previous Clinical Trials

1,922,588 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,708 Previous Clinical Trials

40,932,701 Total Patients Enrolled

Alex Chehrazi-RafflePrincipal InvestigatorCity of Hope Medical Center

Frequently Asked Questions

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

Is the enrollment process ongoing for this medical study?

"Yes, information on clinicaltrials.gov affirms that this trial is actively seeking participants. The study was first listed on June 19th, 2024 and last modified on May 1st, 2024. There is a need for recruitment of 28 patients across one site."

Answered by AI

What is the collective count of individuals actively involved in this research trial?

"Indeed, data on clinicaltrials.gov indicates that this investigation is currently seeking suitable candidates. This study was initially listed on June 19th, 2024, and its most recent update was made on May 1st, 2024. The research team aims to enroll a total of 28 participants at one designated site."

Answered by AI

What are the main goals that this investigation aims to achieve?

"The objective of this investigation, to be observed over a maximum time span of 3 years, is the identification of Dose Limiting Toxicity (DLT). Additional outcomes encompass changes in gut microbiome diversity characterized by The Shannon index calculation for comparison at various intervals. Progression-free survival (PFS), as defined from treatment commencement until disease progression or death using Kaplan-Meier methodology and log-rank testing across dosage tiers. Median PFS duration per dose levels will be reported utilizing Cox proportional hazard modeling without adjusting for covariates. Moreover, overall response rate (ORR) assessed via Response Evaluation Criteria in Solid Tumors"

Answered by AI

What are the safety considerations for individuals undergoing Therapy (CBM588, nivolumab, ipilimumab)?

"The safety rating for the Treatment (CBM588, nivolumab, ipilimumab) is rated as 1 by our team at Power. This score reflects the early Phase 1 nature of the trial and signifies that there is limited data available to support both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CBM588 in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer

2024. "CBM588 in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06399419.

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