Recruiting
Phase 2

CBM588 & Pembrolizumab

Sponsor:

City of Hope Medical Center

Code:

NCT07037004

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Clostridium butyricum CBM588 Strain

Computed Tomography

Pembrolizumab

Study Details

Brief 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. 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.

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

Study ID

NCT07037004

Start date

Jan 1, 2027

Status verified date

Jun, 2026

Completion date

Oct 24, 2028

Anticipated

Primary completion date

Oct 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 (CBM588, pembrolizumab)

Patients 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.

active comparator: Arm 2 (pembrolizumab)

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.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Clostridium butyricum CBM588 Strain

Given PO

Computed Tomography

Undergo CT

Pembrolizumab

Given IV

Primary outcome measure

  • Change in interleukin (IL)-12 levels [ Time Frame: Baseline to week 12 ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Wesley Yip

626-218-4357wyip@coh.org

Principal Investigator:

Wesley Yip

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Contacts

Wesley Yip

626-218-4357wyip@coh.org

Principal Investigator:

Wesley Yip

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-06-09.