Clinical Research Directory

Inclusion Criteria: * \* Participant must be ≥18 years of age inclusive. * \* 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. * \* Patients with clinical tumour stage T2-T4aN0/1M0. * \* Medically fit for treatment with neoadjuvant therapy prior to radical cystectomy. * \* Medically fit to undergo a radical cystectomy at time of enrolment. * \* Have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC. * \* Body weight \>30 kg. * \* Male participants must use a condom plus an additional contraceptive method. * \* Female participants must be postmenopausal or have evidence of nonchildbearing status. * \* Capable of giving signed informed consent. * \* Must have a life expectancy of at least 12 weeks at Enrollement. * \* Adequate bone marrow function (Haemoglobin ≥ 9.0 g/dL, Absolute neutrophil count ≥ 1.5 × 10\^9/L, Platelet count ≥100 x 10\^9/L). * \* Adequate renal function (Creatinine clearance (CrCL) \> 40 mL/min). * \* Adequate hepatic function (Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤2.5 x ULN). Exclusion Criteria: * \* Evidence of lymph node (N2-3) or metastatic TCC/UC (M1), extravesical TCC/UC (T4b), or primary non-bladder TCC/UC. * \* Any unresolved toxicity Grade ≥2 from previous anticancer therapy except for alopecia, vitiligo, and specified laboratory values. * \* Major surgical procedure within 2 weeks of starting study treatment. * \* Requirement for a nephroureterectomy at the time of enrollement for tumour of the mid ureter, renal pelvis, or collecting system. * \* Inoperable tumour(s) with fixation to the pelvic wall on clinical exam. * \* History of allogeneic organ transplantation that requires use of immunosuppressive agents. * \* Active or previously documented autoimmune or inflammatory disorders. * \* Uncontrolled intercurrent illness. * \* History of another primary malignancy, with exceptions. * \* Resting ECG indicating uncontrolled, potentially reversible cardiac conditions. * \* History of active primary immunodeficiency. * \* History of a myocardial infarction within 6 months prior to enrollement. * \* Any clinically significant systemic disease or medical condition that could interfere with the study. * \* Any clinically significant systemic disease or medical condition that could interfere with the study. * \* HIV positive. * \* Any medical contraindication to platinum (Cisplatin)-based doublet chemotherapy. * \* Concurrent chemotherapy, IMP, biologic, or hormonal therapy for cancer treatment. * \* Prior exposure to immune-mediated therapy (with exclusion of BCG). * \* Current or prior use of immunosuppressive medication within 14 days before the first dose of Durvalumab, with exceptions. * \* Prior pelvic radiotherapy treatment within 2 years of enrollement to study. * \* Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. * \* Concomitant use of known strong or moderate CYP3A inhibitors. * \* Concomitant use of known strong or moderate CYP3A inducers. * \* Participation in another clinical study with a study intervention administered in the last 30 days. * \* Involvement in the planning and/or conduct of the study. * \* Involvement in the planning and/or conduct of the study. * \* For females only - currently pregnant or breastfeeding.