CBM588 + Pembrolizumab for Kidney Cancer

Not yet recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Corticosteroids, Immunosuppressives, Probiotics, others

Disqualifiers: Autoimmune disease, Lung disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding CBM588, a type of bacteria that can affect gut health, to pembrolizumab (an immunotherapy drug) can help prevent kidney cancer from returning after surgery. Pembrolizumab already boosts the immune system to fight cancer, and researchers believe CBM588 might enhance its effectiveness. The trial involves two groups: one receiving pembrolizumab alone and another receiving both CBM588 and pembrolizumab. It seeks participants who have had kidney cancer surgery and have not received prior systemic immunotherapy for their condition. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in cancer care.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use probiotics, prebiotics, yogurt, bacterial fortified foods, or other natural supplements within 2 weeks before starting the treatment and during the treatment period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining CBM588 with pembrolizumab may enhance cancer treatment outcomes. CBM588 is a probiotic, a type of beneficial bacteria that might help the immune system combat cancer more effectively. Studies have found that adding CBM588 to immune therapies can improve patient responses to treatment for various cancers, including kidney cancer.

Pembrolizumab is already approved for treating kidney cancer after surgery and has a well-known safety profile, meaning doctors are familiar with its usual side effects and risks. When CBM588 was used with other immune therapies, it appeared to enhance treatment without causing many new side effects. While this is promising, it's important to remember that all treatments can have side effects, and results can vary among individuals. Prospective trial participants should discuss potential risks and benefits with their doctor for more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine pembrolizumab with CBM588, a novel probiotic, to potentially enhance immune response against kidney cancer. Pembrolizumab, an immunotherapy, is already used to fight cancer by helping the immune system recognize and attack cancer cells. The addition of CBM588 is unique because it's believed to modulate the gut microbiome, which may further boost the immune system's ability to combat cancer. This dual approach could offer a more effective treatment option by not only targeting the cancer cells directly but also enhancing the body's natural defenses, unlike standard treatments that typically focus on one mechanism of action.

What evidence suggests that adding CBM588 to pembrolizumab might be an effective treatment for kidney cancer?

This trial will compare the effects of CBM588 combined with pembrolizumab versus pembrolizumab alone for kidney cancer. Research has shown that using CBM588 with immune checkpoint inhibitors, like pembrolizumab, can benefit cancer patients. In one study, patients with advanced kidney cancer lived longer when treated with both CBM588 and standard immunotherapy compared to those who only received the standard treatment. Specifically, the average survival was 55 months with CBM588, compared to 34 months without it. CBM588 works by altering the body's bacteria to enhance the immune system's fight against cancer. Pembrolizumab, already approved for kidney cancer, helps the immune system attack cancer cells more effectively. Together, CBM588 and pembrolizumab may reduce the chance of cancer returning after surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Wesley Yip

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients who've had surgery for renal cell cancer. It's exploring if adding a probiotic (CBM588) to the immunotherapy drug pembrolizumab can prevent cancer from coming back. Participants should not have received prior immunotherapy and must meet certain health standards.

Inclusion Criteria

Be willing and able to provide informed consent for the trial

Any ethnicity or race

My kidney function is within normal ranges.

Exclusion Criteria

Probiotics and natural supplements criteria

Toxicity criteria

Pregnancy and breastfeeding criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CBM588 and/or pembrolizumab for up to 12 months, with cycles repeating every 21 or 42 days

12 months

Monthly visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at 30 days post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Clostridium butyricum CBM 588 Probiotic Strain
• Pembrolizumab

Trial Overview The study compares two approaches: one group receives pembrolizumab with the CBM588 probiotic, while another gets just pembrolizumab after kidney cancer surgery. The goal is to see if the probiotic enhances treatment effectiveness and reduces recurrence.

How Is the Trial Designed?

Group I: Arm 1 (CBM588, pembrolizumab) Experimental Treatment 4 Interventions

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.

Group II: Arm 2 (pembrolizumab) Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07037004

Study Details | NCT07037004 | Adding a Live ... CBM588, a Live Biotherapeutic Product (LBP) containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12325897/

Prognostic Impact of Clostridium butyricum MIYAIRI ... Combining the probiotic product CBM588 with immune checkpoint inhibitors (ICIs) has shown improved prognosis in several cancers.

3. nature.com nature.com/articles/s41591-022-01694-6

Nivolumab plus ipilimumab with or without live bacterial ... The data suggest that CBM588 appears to enhance the clinical outcome in patients with metastatic renal cell carcinoma treated with nivolumab–ipilimumab.

4. vjoncology.com vjoncology.com/video/3vkw8vjlfce-long-term-outcomes-of-cbm588-with-nivolumab-and-ipilimumab-in-mrcc/

ASCO 2025 | Long term outcomes of CBM588 with nivolumab ... The median overall survival in patients who received CBM 588 was 55 months compared to 34 months in patients who received only the standard of care.

5. cityofhope.org cityofhope.org/news/microbiome-and-kidney-cancer

City of Hope and Osel announce live biotherapeutic ... City of Hope announced promising results for live biotherapeutic product CBM588 in using immunotherapy for metastatic kidney cancer.

6. withpower.com withpower.com/trial/phase-2-stage-iv-renal-cell-cancer-ajcc-v8-4-2026-b456f

CBM588 + Pembrolizumab for Kidney Cancer CBM588, a Live Biotherapeutic Product (LBP) containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with ...

7. sigma.larvol.com sigma.larvol.com/product.php?e1=934230&tab=newstrac

Cdactin-O (CBM588) News Cabozantinib (cabo) and nivolumab (nivo) with or without CBM588 in patients with metastatic renal cell carcinoma: Updated clinical outcomes of a phase I study.