Adding CBM588 to pembrolizumab after surgery for kidney cancer
Official title: Impact of Microbiome Modulation With CBM588 in Combination With Pembrolizumab for Adjuvant Therapy of High-Risk, Resected Renal Cell Carcinoma (RCC)
Run by City of Hope Medical Center · NCT07037004 · Data updated 2026-11-12
This trial tests whether adding CBM588 to pembrolizumab after kidney cancer surgery helps prevent recurrence compared with pembrolizumab alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 62 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | immunotherapy, radiation, prednisone, pembrolizumab |
| Locations | 2 sites (Duarte, California and 1 other locations) |
| Status | Recruiting |
| Started | July 8, 2026 |
| Main results expected | October 24, 2028 |
| Study ends | October 24, 2028 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT07037004 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with high-risk, resected renal cell carcinoma (clear-cell or sarcomatoid), suitable organ function, and no prior systemic RCC immunotherapy.
✕Probably not a fit
Patients with disease characteristics or biology that do not respond to immunotherapy or microbiome modulation may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 trial compares pembrolizumab with and without the live biotherapeutic CBM588 following surgical treatment for high-risk renal cell carcinoma. Participants are randomized to receive pembrolizumab alone or CBM588 plus pembrolizumab, with CBM588 given orally in defined cycles. The study will evaluate immune and microbiome changes, disease-free survival, overall survival, and safety. It includes adults with clear-cell or sarcomatoid RCC who have had resection and meet specific organ function and performance criteria. Outcomes will inform whether microbiome modulation can enhance immunotherapy response in this setting.
Why it matters
Potential benefit: If successful, patients may have a lower risk of cancer recurrence and potentially improved survival by boosting the effectiveness of pembrolizumab.
How similar studies have gone: Prior work suggests microbiome modulation can influence immunotherapy responses in some cancers, but results vary and this approach is still being studied in RCC.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
City of Hope Medical Center
Duarte, California, United States Recruiting -
City of Hope at Irvine Lennar
Irvine, California, United States Recruiting
Study contacts
- Principal investigator: Wesley Yip — City of Hope Medical Center
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.