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Clinical Trials/JPRN-jRCTs031220689
JPRN-jRCTs031220689
Recruiting
Phase 2

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

Taguchi Satoru0 sites30 target enrollmentMarch 9, 2023

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Taguchi Satoru
Enrollment
30
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 9, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Taguchi Satoru

Eligibility 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

  • (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

Outcomes

Primary Outcomes

Not specified

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