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Clinical Trials List

Protocol NumberD933SC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03682068
Active

2018-09-26 - 2022-05-18

Phase III

Recruiting6

ICD-10C67.9

Malignant neoplasm of bladder, unspecified

ICD-10C67

Malignant neoplasm of bladder

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer.

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Hsiao-Jen Chung Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hsiang Chang Division of Urology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jian-Ri Li Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Chao-Hsiang Chang 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Po-Jung Su Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

蘇柏榮

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Recruiting

Audit

None

Principal Investigator CHUNG-HSIN CHEN Division of Urology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Condition/Disease

Locally Advanced or Metastatic Urothelial Cancer

Objectives

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

Test Drug

Durvalumab (MEDI4736)

Active Ingredient

Humanized anti-CTLA-4 mAb
Humanized anti-PD-1 mAb

Dosage Form

injection

Dosage

50
20

Endpoints

Primary Outcome Measures :
Overall Survival (OS) [ Time Frame: approximately 5 years ]
OS is defined as the time from the date of randomization until death due to any cause

Inclution Criteria

Key Inclusion Criteria:

-Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra)
-Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred >12 months from the last therapy [for chemoradiation and adjuvant treatment] or >12 months from the last surgery [for neoadjuvant treatment].
-At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline.
-World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment
-Adequate organ and marrow function as defined in the protocol
-Life expectancy ≥12 weeks in the opinion of the investigator
-Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.

Exclusion Criteria

Key Exclusion Criteria:

-Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment.
-No severe concomitant condition that requires immunosuppression medication
-Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
-Patients who may be eligible for or are being considered for radical resection during the course of the study.
-Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    1735 participants

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