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Adding CBM588 to Pembrolizumab for Renal Cell Cancer After Surgery

This study is looking at whether adding a live biotherapeutic product called CBM588 to pembrolizumab (an immunotherapy drug) can help prevent kidney cancer from coming back after surgery. Pembrolizumab works by helping your body's immune system fight cancer cells. Researchers believe that changes in the healthy bacteria in your body (your microbiome) might improve how well immunotherapy works. This trial will compare patients who receive CBM588 plus pembrolizumab to those who receive pembrolizumab alone. The main goal is to see if CBM588 increases a specific immune marker (interleukin-12 levels) and if it improves how long patients live without the cancer returning. You may be able to join if you have clear cell or sarcomatoid renal cell carcinoma that has been surgically removed and meet other criteria.

Study design
This is an interventional study with a planned enrollment of 62 participants. Patients will be randomly assigned to one of two groups: one receiving CBM588 and pembrolizumab, and the other receiving pembrolizumab alone.
What's involved
Participants will receive CBM588 orally or pembrolizumab intravenously (IV) in cycles for up to 12 months. You will also have blood samples collected and undergo CT scans throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in interleukin-12 levels from baseline to week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07037004

Adding a Live Biotherapeutic Product (CBM588) to Pembrolizumab for the Treatment of Renal Cell Cancer After Surgery

Recruiting
PHASE2Ages 18+InterventionalTreatment
City of Hope Medical Center
~62 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Biospecimen CollectionClostridium butyricum CBM588 StrainComputed TomographyPembrolizumab

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in interleukin (IL)-12 levels
Measured over Baseline to week 12

Conditions

Clear Cell Renal Cell Carcinoma
Sarcomatoid Renal Cell Carcinoma
Stage II Renal Cell Cancer AJCC v8
Stage III Renal Cell Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8

Explore related trials

Renal Cell Carcinoma

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Wesley Yip · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Wesley Yip
[email protected]
626-218-4357
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Be willing and able to provide informed consent for the trial
Histological confirmation of renal cell carcinoma (RCC) with a clear-cell or sarcomatoid component
Pathologic stage of pT2, G4 or sarcomatoid, N0M0; pT3, any grade, N0M0; pT4, any grade, N0M0; pTany, any grade, N+M0; or M1 no evidence of disease (NED) after resection
No prior systemic immunotherapy for RCC
Eastern Cooperative Oncology Group (ECOG) performance status \< 2
Males and females, ages ≥ 18
Any ethnicity or race
Calculated creatinine clearance ≥ 30 milliliters per minute (mL/min) per the Cockcroft and Gault formula or serum creatinine \< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 x ULN (\< 5 x ULN if liver metastases are present)
Total bilirubin \< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin up to 3.0 mg/dL)
Adequate bone marrow function defined by any of the following laboratory test findings: white blood cells (WBC) \> 2,000/mm\^3, neutrophils \> 1,500/mm\^3, platelets \> 100,000/mm\^3
Female subjects of child-bearing potential and female partners of male subjects must agree to use a highly effective method of contraception during treatment and for at least 5 months after the last dose
Highly effective methods of contraception include: tubal ligation, an approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings or hormonally impregnated intrauterine device (IUD), or IUD

Exclusion

Prior radiation or anti-PD1, anti-PDL1, or anti-CTLA-4 therapy for RCC
Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll
Active interstitial lung disease (ILD)/pneumonitis or history of ILD/pneumonitis requiring treatment with systemic steroids
Baseline pulse oximetry less than 92% "on room air"
Current use, or intent to use probiotics, prebiotics, yogurt, bacterial fortified foods and other natural supplements ≤ 2 weeks prior to treatment initiation and during the period of treatment
Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
Uncontrolled adrenal insufficiency
Known medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results
Not recovered to ≤ grade 1 toxicities related to any prior therapy before administration of study drug
Women who are pregnant or breastfeeding
History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry

What this trial measures

  • Change in interleukin (IL)-12 levelsBaseline to week 12

    A two-sample t-test will be used to test the difference in the changes in IL-12 production for the two treatment arms. A Wilcoxon rank-sum test will be used if the changes are not normally distributed (p\< 0.05 by a Shapiro-Wilks test).