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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07037004
Phase
PHASE2
Status
Recruiting
Apply to this trial

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 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Clostridium butyricum CBM588 Strain — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jan 1, 2027
Status verified
Jun 2026
Primary completion
Oct 24, 2028
Completion
Oct 24, 2028

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Wesley Yip
[email protected]
626-218-4357
Wesley Yip (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Wesley Yip
[email protected]
626-218-4357
Wesley Yip (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CA

Related Studies