CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic… (NCT05122546) | Clinical Trial Compass
Active — Not RecruitingPhase 1
CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer
United States31 participantsStarted 2021-11-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histological confirmation of renal cell carcinoma (RCC) with a clear-cell, papillary or sarcomatoid component
* Advanced (not amenable to curative surgery or radiation therapy) or metastatic (American Joint Committee on Cancer \[AJCC\] stage IV) RCC
* No prior systemic therapy for RCC with the following exception:
* One prior adjuvant or neoadjuvant therapy for completely resectable RCC if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Recovery to baseline or =\< grade 1 CTCAE v5 from toxicities related to any prior treatments unless adverse events (AE\[s\]) are clinically nonsignificant and/or stable on supportive therapy
* Karnofsky performance status \>= 70%
* Males and females, ages \>= 18
* Any ethnicity or race
* Absolute neutrophil count (ANC) \>= 1500/uL without granulocyte colony-stimulating factor support (within 14 days before first dose of study treatment)
* White blood cell count \>= 2500/uL (within 14 days before first dose of study treatment)
* Platelets \>= 100,000/uL without transfusion (within 14 days before first dose of study treatment)
* Hemoglobin \>= 9 g/dL (\>= 90 g/L) (within 14 days before first dose of study treatment)
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) =\< 3 x upper limit of normal (ULN). ALP =\< 5 x ULN with documented bone met…