Clinical trial NCT02302807 (phase 3, status: completed)
Conditions: bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: atezolizumab (mpdl3280a) [tecentriq], an engineered anti-pdl1 antibody, docetaxel, paclitaxel, vinflunine
SMILES: CCCNCC(O)COC1=C(C=CC=C1)C(=O)CCC1=CC=CC=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, CC[C@@]12C=CCN3CC[C@@]4([C@H]13)[C@@H](N(C)C1=CC(OC)=C(C=C41)[C@]1(C[C@@H]3C[C@H](C[N@@](C3)CC3=C1NC1=CC=CC=C31)C(C)(F)F)C(=O)OC)[C@](O)([C@@H]2OC(C)=O)C(=O)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically documented locally advanced or metastatic UBC
             (including renal pelvis, ureters, urinary bladder, and urethra).

          -  Representative tumor specimens as specified by the protocol

          -  Disease progression during or following treatment with at least one
             platinum-containing regimen for inoperable, locally advanced or metastatic UBC or
             disease recurrence

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Life expectancy greater than or equal to (>/=) 12 weeks

          -  Measurable disease, as defined by RECIST v1.1

          -  Adequate hematologic and end organ function

          -  For women of childbearing potential, agreement to refrain from heterosexual
             intercourse or use contraceptive methods that result in a failure rate of < 1% per
             year during the treatment period and for at least 5 months after the last dose of
             atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last
             dose of paclitaxel or docetaxel.

          -  For men, agreement to refrain from heterosexual intercourse or use contraceptive
             methods that result in a failure rate of < 1% per year during the treatment period and
             for at least 3 months after the last dose of vinflunine and 6 months from the last
             dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm

        Exclusion Criteria:

          -  Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment

          -  Treatment with any other investigational agent or participation in another clinical
             trial with therapeutic intent within 28 days prior to enrollment

          -  Active or untreated central nervous system (CNS) metastases as determined by computed
             tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and
             prior radiographic assessments

          -  Leptomeningeal disease

          -  Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception
             of those with a negligible risk of metastasis or death and treated with expected
             curative outcome, or localized prostate cancer treated with curative intent and
             absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer

          -  Pregnant and lactating women

          -  Significant cardiovascular disease

          -  Severe infections within 4 weeks prior to randomization

          -  Major surgical procedure other than for diagnosis within 4 weeks prior to
             randomization

          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to
             chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy
             to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the
             atezolizumab formulation

          -  History of autoimmune disease

          -  Prior allogeneic stem cell or solid organ transplant

          -  History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
             pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
             chest CT scan

          -  Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or
             hepatitis C or tuberculosis

          -  Administration of a live, attenuated vaccine within 4 weeks prior to randomization

          -  Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
             checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated
             protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed
             death-ligand 1 (anti-PD-L1) therapeutic antibodies