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Clinical Trials List

Protocol NumberD933RC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03732677
Active

2018-09-28 - 2026-12-31

Phase III

Recruiting6

Terminated1

ICD-10C67

Malignant neoplasm of bladder

ICD-9188.8

Malignant neoplasm of other specified sites of bladder

A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

  • Trial Applicant

  • Sponsor

    AstraZeneca Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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 Hsiao-Jen Chung Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chuan-Shu Chen Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator See-Tong Pang Division of Urology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃冠華 Division of Urology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

Audit

CRO

Principal Investigator YU-CHUAN LU Division of Urology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Jeng Wu Division of Urology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

Muscle-Invasive Bladder Cancer

Objectives

To evaluate the combination of durvalumab + G+C therapy (leading adjuvant)/durvalumab alone (adjuvant) (group 1) compared to G+C combined therapy (leading adjuvant)/none in MIBC patients with adequate renal function The effect of adjuvant therapy (group 2) on pCR and EFS

Test Drug

Durvalumab

Active Ingredient

Durvalumab (Humanized anti-PD-1 mAb)

Dosage Form

Injection

Dosage

50

Endpoints

The pathological complete response (pCR) is evaluated by the Central Pathology Review Committee, and the event-free survival rate (EFS) is evaluated by the Blind Central Independent Review Committee (BICR)

Inclution Criteria

Informed consent
1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
2. Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
3. Age ≥18 years at the time of screening. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
4. Patients with histologically or cytologically documented muscle-invasive TCC (also known as UC) of the bladder. Patients with transitional cell and mixed transitional/non-transitional cell histologies (adenocarcinoma, squamous cell)/variant transitional (eg, micropapillary, plasmacytoid, sarcomatoid, nested variant, lymphoepitheliod, nested variant) with clinical stage of T2N0M0-T4aN0M0 according to the American Joint Committee on Cancer Staging Manual (AJCC Cancer Staging Manual, 8th Edition) TCC of the bladder are eligible. Patients with pure non-transitional cell variant histologies and any small cell histology are not eligible.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment.
6. Tumor PD-L1 status, with immunohistochemistry (IHC) assay confirmed by a reference laboratory, must be known prior to randomization. As such, all patients must give valid written consent to provide a newly acquired MIBC tumor biopsy during
screening (preferred) or provide an available archival MIBC tumor sample taken ≤3 years prior to screening. Tumor lesions submitted must be when the patient was determined to have MIBC (ie, NMIBC samples will not be acceptable). Samples with
limited tumor content are not acceptable. The tumor specimen submitted to evaluate PD-L1 status should be of sufficient quantity to allow for PD-L1 IHC, retrospective evaluation of muscle invasive disease, and other exploratory biomarker analyses and is preferred in formalin-fixed paraffin-embedded (FFPE) blocks.
7. Adequate organ and marrow function as defined below:
8. Must have a life expectancy of at least 12 weeks at randomization.
9. Body weight >30 kg at enrollment and randomization
10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

Exclusion Criteria

1. Evidence of lymph node or metastatic TCC/UC, extravesical TCC/UC that invades the pelvic and/or abdominal wall for bladder cancer (T4b), or primary non-bladder (ie, ureter, urethral, or renal pelvis) TCC/UC of the urothelium. Patients with radiologically suspected lymph node metastasis should be excluded if the short axis is ≥10 mm as per IV contrast-enhanced CT or MRI scan.
2. Inoperable tumor(s) with fixation to the pelvic wall on clinical exam.
3. History of allogeneic organ transplantation that requires use of immunosuppressive agents. Patients with a history of allogenic stem cell transplantation are also excluded.
4. Active or prior documented autoimmune or inflammatory disorders.
5. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled diabetes, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious
chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
6. History of another primary malignancy
7. History of active primary immunodeficiency
8. History of leptomeningeal carcinomatosis
9. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface
antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
10. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
11. New York Heart Association Class III or IV heart failure (Criteria Committee NYHA 1964).
12. QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≥470 ms calculated. Any clinically significant abnormalities detected require triplicate ECG results and a mean QTcF ≥470 ms calculated from 3 ECGs obtained over a brief
period (eg, 30 minutes).
13. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
14. Any medical contraindication to platinum (cisplatin)-based doublet chemotherapy,
including:
 CTCAE Grade ≥2 audiometric hearing loss
 CTCAE Grade ≥2 peripheral neuropathy
15. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
16. Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies.
17. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note:
Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
18. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
19. Prior pelvic radiotherapy treatment
20. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are
21. Prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of the treatment arm (until the primary endpoint of that study has read out)
22. Previous IP assignment in the present study
23. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
24. Participation in another clinical study with an IP administered during the last 28 days
25. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab.

The Estimated Number of Participants

  • Taiwan

    70 participants

  • Global

    1250 participants

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