advanced urothelial carcinoma advanced urothelial carcinoma
Conditions
Interventions
Participants will be randomized in 1:1 ratio to pembrolizumab with MIYA-BM or pembrolizumab alone
Clostridium butyricum MIYAIRI
Sponsors
Taguchi Satoru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactSatoru Taguchi
The University of Tokyo Hospital
Outcome results
None listed