A prospective study to investigate the effect of CBM558 combined with pembrolizumab on gut microbiota and prognosis in patients with advanced urothelial carcinoma.
- Conditions
- advanced urothelial carcinoma
- Registration Number
- JPRN-jRCTs031220689
- Lead Sponsor
- Taguchi Satoru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method (1) overall survival (OS)<br>(2) objective response rate (ORR)<br>(3) disease-control rate (DCR)<br>(4) Change of gut microbiota analyzed using fecal samples at 12 weeks from baseline<br>(5) Change of peripheral blood immune cells at 3 and 12 weeks from baseline