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CBM588 + Nivolumab/Ipilimumab for Kidney Cancer

Phase 1
Recruiting
Led By Alexander Chehrazi-Raffle, M.D.
Research Sponsored by Osel, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Advanced or metastatic renal cell carcinoma with intermediate- or poor-risk disease by IMDC criteria
Age ≥ 18 years
Must not have
Active malignancy at time of study treatment or diagnosis of another malignancy within 3 years requiring active treatment except for specified cases
Active interstitial lung disease or history of ILD/pneumonitis requiring treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Summary

This trial will test the safety and effectiveness of increasing doses of CBM588 when used with nivolumab and ipilimumab. They will start with a small group to find the highest safe

Who is the study for?
This trial is for adults with advanced kidney cancer, specifically Renal Cell Carcinoma. Participants must be able to take oral medication and have not been treated with Nivolumab or Ipilimumab before. People who've had certain other treatments or health conditions that could interfere with the study are excluded.
What is being tested?
The study tests different doses of CBM588 capsules combined with standard doses of Nivolumab and Ipilimumab to find the highest dose patients can tolerate without severe side effects (MTD). After finding MTD, they'll expand the group to further check safety and how well it works.
What are the potential side effects?
Possible side effects include immune-related reactions affecting various organs, infusion reactions from Nivolumab/Ipilimumab, fatigue, gastrointestinal issues like diarrhea or colitis, skin problems, hormone gland disorders (like thyroid), and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney cancer is advanced or has spread and is not responding well to treatment.
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I am 18 years old or older.
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I have recovered from the side effects of my previous cancer treatment.
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My kidney cancer has been confirmed to be clear cell or sarcomatoid type.
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My blood, liver, kidney, and clotting tests are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not been treated for another cancer within the last 3 years.
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I have or had lung inflammation that needed treatment.
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I have been treated with ipilimumab or nivolumab before.
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I have a rare condition that makes it hard for me to process some sugars.
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I have not received a live vaccine in the last 30 days.
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I do not have any severe ongoing illnesses.
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I cannot swallow pills or receive treatments through IV.
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My surgical wounds have not fully healed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the number of participants with treatment-related adverse events of CBM588 given concurrently with nivolumab/ipilimumab as assessed by CTCAE v5.0.
To determine the number of participants with treatment-related dose limiting toxicity (DLT) of CBM588 at each dose level in combination with nivolumab/ipilimumab.
Secondary outcome measures
Best overall response rate (ORR)
Effects on microbiome - Genera and species abundance
Effects on microbiome - Metabolic pathways
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CBM588 CapsulesExperimental Treatment3 Interventions
This will be a dose escalation study of CBM588 oral capsules at two potencies in combination with nivolumab and ipilimumab dual immune checkpoint therapy: 1x Capsule containing 4.0E+8 CFU/capsule; and 10x Capsule containing 4.0E+9 CFU/capsule. The dose escalation will begin with one 1x Capsule administered twice a day followed by three 1x Capsules b.i.d., and then one 10x Capsule b.i.d. until disease progression or dose limiting toxicity occurs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4740

Find a Location

Who is running the clinical trial?

Osel, Inc.Lead Sponsor
6 Previous Clinical Trials
225 Total Patients Enrolled
City of Hope Comprehensive Cancer CenterOTHER
5 Previous Clinical Trials
298 Total Patients Enrolled
Miyarisan Pharmaceutical Co., Ltd.UNKNOWN
~19 spots leftby Apr 2026
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