Study to evaluate the efficacy and safety of Durvalumab(MEDI4736) in combination with intravesical BCG for the treatment of patients diagnosed with early stage bladder cancer (non-muscle invasive) compared to the standard therapy of intravesical BCG alone.

You likely can't join if

• -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 renalpelvis), non-muscle-invasive transitional cell carcinoma of the urothelium. -Previous investigational product (IP) assignment in the present study. -Any concurrent chemotherapy, IP, biologic, or hormonaltherapy for cancer treatment. Concurrent use of hormonaltherapy for noncancer related conditions (eg, hormonereplacement therapy) is acceptable. Chemotherapy for previous instances of NMIBC is acceptable. Patients who have received a single instillation of Mitomycin C orequivalent chemotherapy agent immediately after TURBT can be enrolled in the study. -Active infection including TB, hepatitis B (known positivehepatitis B virus [HBV] surface antigen [HBsAg] result),hepatitis C virus (HCV), or human immunodeficiency virus(HIV [positive HIV] 1/2) antibodies. Patients with a pastor resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) areeligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Appropriate TB tests (e.g.skin or interferon gamma tests) should be performed to exclude TB infection requiring treatment. Additional clinical evaluations including clinical history, physical examination, radiographic findings, and other diagnostic procedures and specialist consultations should be performed if necessary. -Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroidinjections (eg, intra articular injection) Systemic corticosteroids at physiologic doses not toexceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions(eg, computed tomography [CT] scan premedication) -Active or prior documented autoimmune or inflammatorydisorders (including inflammatory bowel disease [eg,colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegenersyndrome [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 Hashimotosyndrome) stable on hormone replacement. Any chronic skin condition that does not requiresystemic therapy Patients without active disease in the last 5 years maybe included but only after consultation with the Study Physician − Patients with celiac disease controlled by diet alone − History of another primary malignancy except for Malignancy treated with curative intent and with noknown active disease ≥ 2 years before the first dose of IPand of low potential risk for recurrence during study period Adequately treated nonmelanoma skin cancer or lentigomaligna without evidence of disease Adequately treated CIS without evidence of disease Prostate cancer (tumor/node/metastasis stage) of stage≤ T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention.