Randomized study as second-line chemotherapy in mUC patients between gemcitabine and docetaxel regimen and pembrolizumab.

Randomized study as second-line chemotherapy in mUC patients between gemcitabine and docetaxel regimen and pembrolizumab. - Randomized study as second-line chemotherapy in mUC patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032805

Enrollment

Registered

2018-06-20

Start date

2018-06-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic urothelial carcinoma patients after treated first-line cisplatin based chemotherapy

Interventions

gemcitabine and docetaxel combination chemotherapy immunotherapy using pembrolizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The following World Health Organization criteria were met by all the enrolled patientsan adequate bone marrow reserve, reasonable hepatic function, and an estimated life expectancy of over 12 weeks. Ineligible patients included those with non-malignant systemic disease, such as active infection that precluded them from receiving therapy, or those with any clinically significant cardiac arrhythmia, and/or congestive heart failure. All patients provided written informed consent prior to this clinical trial. The institutional chemotherapy review boards (ethical committees) of Nagoya City University Hospital and Nagoya City University

Exclusion criteria

Exclusion criteria: 1. allergy of gemcitabine, docetaxel, pembrolizumab patients. 2. interstitial pneumoniae, performed external radiation therapy in chest 3. sign of bacterial of viral infection patients. 4. pregnant or lactational patients 5. other cancer

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
adverse events, overall survival, response to treatment, QOL after 2 cycles of treatment	—

Countries

Japan

Contacts

Public ContactNoriyasu Kawai

Nagoya City University Graduate School of Medical Sciences Department of Nephro-urology

n-kawai@med.nagoya-cu.ac.jp052-853-8266

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026