A prospective study to investigate the effect of CBM558 combined with pembrolizumab on gut microbiota and prognosis in patients with advanced urothelial carcinoma.

JRCT ID: jRCTs031220689

Registered date:09/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: advanced urothelial carcinoma
• Date of first enrollment: 08/06/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Participants will be randomized in 1:1 ratio to pembrolizumab with MIYA-BM or pembrolizumab alone

Outcome(s)

• Primary Outcome: progression-free survival (PFS)

Secondary Outcome

(1) overall survival (OS)
(2) objective response rate (ORR)
(3) disease-control rate (DCR)
(4) Change of gut microbiota analyzed using fecal samples at 12 weeks from baseline
(5) Change of peripheral blood immune cells at 3 and 12 weeks from baseline

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) With unresectable (recurrent, locally advanced, or metastatic) urothelial cancer (bladder, ureters, and urethra cancer)
(2) With cancer progression after chemotherapy, intolerance to chemotherapy or ineligible for chemotherapy
(3) With lesion which is measurable based on RECIST 1.1
(4) Scheduled to take pembrolizumab
(5) Aged 18 years and above at the time of informed consent
(6) Male or female
(7) Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation

Exclude criteria

(1) With a history of allergy to pembrolizumab or components of butyrate-producing probiotics
(2) Taking butyrate-producing probiotics and unable to have washout period of above 5 days prior to experimental treatment
(3) Pregnant or possible pregnant
(4) Lactating female
(5) Judged as ineligible by clinical investigators

Related Information

• Primary Sponsor: Taguchi Satoru