CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05122546
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Clear Cell Renal Cell Carcinoma
  • Advanced Papillary Renal Cell Carcinoma
  • Advanced Renal Cell Carcinoma
  • Advanced Sarcomatoid Renal Cell Carcinoma
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Metastatic Papillary Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Metastatic Sarcomatoid Renal Cell Carcinoma
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8
  • Unresectable Clear Cell Renal Cell Carcinoma
  • Unresectable Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase I trial evaluates the effects of CBM588 in combination with standard therapies, nivolumab and cabozantinib, in treating patients with kidney cancer that has spread to other places in the body (advanced/metastatic). The digestive microbiome may have an effect on how patients respond to treatment, and previous research shows that a specific bacteria found in the gut (Bifidobacterium) may predispose participants to a better response to standard therapies. CBM588 is a strain of bacteria that can restore species of Bifidobacterium to the microbiome. The primary aim of this study is to determine how CBM588 changes the microbiome of patients with metastatic renal cell carcinoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving CBM588, nivolumab, and cabozantinib may kill more tumor cells.

Key Dates

Start date
Nov 1, 2021
Status verified
Mar 2026
Primary completion
Jan 12, 2027
Completion
Jan 12, 2027

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 2 (CBM588, nivolumab, cabozantinib S-malate)
    Patients receive CBM588 PO BID, nivolumab IV over 30 minutes on day 1, and cabozantinib S-malate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm I (nivolumab, cabozantinib S-malate)
    Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Change in Bifidobacterium composition of stool [ Time Frame: Baseline to week 12 of therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

Find similar trials in Duarte, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
City of Hope Medical Center· Duarte, CA

Related Studies