Urothelial Carcinoma, locally advanced or metastatic MedDRA version: 19.0 Level: LLT Classification code 10064467 Term: Urothelial carcinoma System Organ Class: 100000004864
Conditions
Sponsors
Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Eastern Cooperative Oncology Group performance status of =65 years) yes F.1.3.1 Number of subjects for this age range 265
Exclusion criteria
Exclusion criteria: - Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment - Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment - Active or untreated central nervous system metastases as determined by computed tomography or magnetic resonance imaging evaluation during screening and prior radiographic assessments - Leptomeningeal disease - Uncontrolled hypercalcemia, tumor-related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1 General Medical Exclusions: - Life expectancy of < 12 weeks - Pregnant or lactating, or intending to become pregnant during the study - Serum albumin < 2.5 gram per deciliter Exclusion Criteria Related to Atezolizumab: - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - History of autoimmune disease - Patients with prior allogeneic stem cell or solid organ transplantation - History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia or evidence of active pneumonitis - Significant cardiovascular disease - Known left ventricular ejection fraction < 40% - Positive test for HIV - Active hepatitis B or hepatitis C, tuberculosis - Severe infections within 4 weeks prior to randomization - Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization - Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 - Prior treatment with Cluster of Differentiation (CD) 137 agonists, anti- cytotoxic T-lymphocyte-associated protein (CTLA)-4, anti? programmed cell death protein (PD)-1, or anti?PD-L1 therapeutic antibody or pathway-targeting agents - Treatment with systemic immunostimulatory agents, systemic corticosteroids or other systemic immunosuppressive medications - Known hypersensitivity to gemcitabine - History of severe allergic reactions to cisplatin or other platinum-containing compounds - Severe bone marrow depression or significant bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To evaluate the efficacy of atezolizumab plus gemcitabine/carboplatin compared with placebo plus gemcitabine/carboplatin based on progression-free survival (PFS) and overall survival (OS);Primary end point(s): 1. PFS as assessed by the investigator using RECIST v1.1 2. OS;Timepoint(s) of evaluation of this end point: 1-2. Up to 33 months;Secondary Objective: ? To evaluate the efficacy of atezolizumab plus gemcitabine/carboplatin compared with placebo plus gemcitabine/carboplatin based on objective response rate (ORR), duration of response (DOR), PFS assessed by Independent Review Facility (IRF), OS rate, PFS rate, time to deterioration in global health status and in physical function as measured by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life (QLQ) Questionnaire Core 30 ? To evaluate the safety and tolerability of atezolizumab plus gemcitabine/carboplatin compared with placebo plus gemcitabine/carboplatin ? To characterize the pharmacokinetics (PK) of atezolizumab when administered in combination with gemcitabine/carboplatin in patients who are treatment-naive and who are ineligible for cisplatin-based chemotherapy ? To evaluate the immune response to atezolizumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1-3. Up to 33 months 4-5. 1 year 6-8. Up to 33 months 9-10. Pre-dose Cycle (C) 1 Day (D) 1, D1 of C2, C3, C4, and C8, at treatment discontinuation, 120 days (+/- 30 days) after last dose of atezolizumab;Secondary end point(s): 1. Objective Response Rate (ORR) 2. Duration of Response (DOR) 3. PFS assessed by Independent Review Facility (IRF) 4. OS rate 5. PFS rate 6. Time to deterioration in global health status and physical function as measured by the EORTC QLQ-C30 Safety 7. Incidence, nature and severity of adverse events 8. Changes in vital signs and clinical laboratory results Pharmacokinetic 9. Maximum and minimum serum concentration of atezolizumab Immunogenicity 10. Incidence of anti-therapeutic antibodies (ATAs) during the study relative to the prevalence of ATAs at baseline | — |
Countries
Australia, Brazil, Chile, China, Czech Republic, Estonia, Greece, Hong Kong, Italy, Korea, Republic of, Mexico, Poland, Romania, Russian Federation, Serbia, Slovenia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed