Non-muscle-invasive Bladder Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Durvalumab (MEDI4736), Bacillus Calmette-Guerin (BCG)
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage a
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: - BCG-naive patients (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible) - Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high risk tumor is defined as one of the following _T1 tumor _High grade/ G3 tumor _CIS _Multiple and recurrent and large (with diameter of largest tumor more than 3 cm) tumors (all conditions must be met9 in this point) - Complete resection of all Ta/T1 papillary disease prior to randomization, with the TURBT removing high-risk NMIBC performed not more than 4 months before randomization in the study. Patients with residual CIS after TURBT are eligible - No prior radiotherapy for bladder cancer - No prior exposure to immune-mediated therapy of cancer including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 antibodies. Patients who have been treated with anticancer vaccines will be excluded
Exclusion criteria
Exclusion criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: - Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV) - Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium - Previous investigational product (IP) assignment in the present study - Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer related conditions (eg, hormone replacement therapy) is acceptable. Chemotherapy for previous instances of NMIBC is acceptable. - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: _Patients with vitiligo or alopecia _Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement _Any chronic skin condition that does not require systemic therapy _Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician _Patients with celiac disease controlled by diet alone - History of another primary malignancy - Active infection including TB, HBV, HCV and HIVActive infection - Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| confirmatory efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics efficacy - | — |
Countries
Europe, Japan, North America, Oceania
Outcome results
None listed