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Clear Cell Renal Cell CarcinomaPhase 2NCT07037004

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

A Phase 2 study testing Biospecimen Collection, Clostridium butyricum CBM588 Strain and Computed Tomography in people with Clear Cell Renal Cell Carcinoma and Sarcomatoid Renal Cell Carcinoma, run by City of Hope Medical Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Clostridium butyricum CBM588 Strain and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesUnited States
Study dates
8 Jul 2026to 24 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Wesley Yip, 626-218-4357, wyip@coh.org

    Wesley Yip

    Recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Wesley Yip, 626-218-4357, wyip@coh.org

    Wesley Yip

    Recruiting

Other trials in United States

About this study

Official title: Impact of Microbiome Modulation With CBM588 in Combination With Pembrolizumab for Adjuvant Therapy of High-Risk, Resected Renal Cell Carcinoma (RCC)

This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. Research has shown that changes to the composition of the healthy bacteria in the body (the microbiome), may improve a patient's response to treatment with immunotherapy. CBM588, a Live Biotherapeutic Product (LBP) containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with immunotherapy for other types of cancer. Adding CBM588 to treatment with pembrolizumab after surgery may cause changes in the microbiome that improve patient response to treatment and reduce disease recurrence, compared to pembrolizumab alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if the Clostridium butyricum CBM588 strain (CBM588) increases interleukin (IL)-12 production in patients with high-risk, resected renal cell carcinoma (RCC) receiving pembrolizumab.

SECONDARY OBJECTIVES:

  1. To determine if CBM588 improves recurrence-free survival (RFS) in patients with high-risk, resected renal cell carcinoma (RCC) receiving pembrolizumab.

II. To determine if CBM588 improves overall survival (OS) in patients with high-risk, resected renal cell carcinoma (RCC) receiving pembrolizumab.

III. To characterize global changes in stool microbiome profile in patients with high-risk, resected RCC receiving pembrolizumab with or without CBM588.

IV. To characterize changes in circulating cytokine and immune cell populations in patients with high-risk, resected RCC receiving pembrolizumab with or without CBM588.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive CBM588 orally (PO) twice daily (BID) on days 1-21 or days 1-42 of each cycle and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and computed tomography (CT) throughout the study.

ARM 2: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT throughout the study.

After completion of study treatment, patients are followed up at 30 days.

Being tested
Biospecimen Collection, Clostridium butyricum CBM588 Strain, Computed Tomography, Pembrolizumab
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Clostridium butyricum CBM588 StrainDrug

    Also called C. butyricum CBM588 Strain, C. butyricum MIYAIRI Strain, C. butyricum Strain MIYAIRI 588, CBM588

    Given PO

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given IV

Study groups in NCT07037004
Study groupRoleWhat they receive
Arm 1 (CBM588, pembrolizumab)ExperimentalPatients receive CBM588 PO BID on days 1-21 or days 1-42 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Clostridium butyricum CBM588 Strain; Procedure: Computed Tomography; Biological: Pembrolizumab
Arm 2 (pembrolizumab)Active comparatorPatients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in interleukin (IL)-12 levels

    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).

    Measured: Baseline to week 12

Secondary outcomes (7)

  1. Recurrence-free survival (RFS)

    RFS will be estimated by the Kaplan-Meier method. Median RFS and landmark RFS rates (e.g., 1-year and 2-year RFS) will be calculated with confidence intervals. Log-rank test will be used to compare the distribution between groups. Cox proportional hazards model will be used to estimate hazard ratios with 95% confidence intervals.

    Measured: From randomization to disease recurrence or death, assessed up to 1 year

  2. Overall survival (OS)

    OS will be estimated by the Kaplan-Meier method. Median OS and landmark OS rates (e.g., 1-year and 2-year OS) will be calculated with confidence intervals. Log-rank test will be used to compare the distribution between groups. Cox proportional hazards model will be used to estimate hazard ratios with 95% confidence intervals.

    Measured: From randomization to death from any cause, assessed up to 1 year

  3. Shannon diversity index

    A comparison of the Shannon diversity index (a measure of microbial diversity) from baseline to week 12 will be conducted.

    Measured: Baseline to week 12

  4. Proportion of circulating regulatory T cells (Tregs)

    Will estimate the proportion of Tregs in the blood.

    Measured: Baseline to week 12

  5. Proportion of circulating myeloid derived suppressor cells (MDSCs)

    Will estimate the proportion of MDSCs in the blood.

    Measured: Baseline to week 12

  6. IL-6, IL-8 and other cytokines/chemokines

    Will compare IL-6, IL-8 and other cytokines/chemokines.

    Measured: Baseline to week 12

  7. Incidence of toxicities

    Toxicities such as diarrhea and nausea will be assessed using Common Terminology Criteria for Adverse Events version 5 criteria. Will perform statistical analysis to compare the rates of all grade and grade ≥ 3 treatment related adverse events.

    Measured: Up to 30 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start8 Jul 2026
  3. Primary completion24 Oct 2028 (estimated)
  4. Study completion24 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037004
Sponsor's protocol ID
24709
Other IDs
NCI-2025-04100, 24709, P30CA033572
Status last verified
Oct 2026
First submitted
13 Jun 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Clostridium butyricum CBM588 Strain and Computed Tomography in people with Clear Cell Renal Cell Carcinoma and Sarcomatoid Renal Cell Carcinoma, run by City of Hope Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in interleukin (IL)-12 levels (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07037004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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