IMvigor130: Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02807636
• Collaborator: (none)
• Enrollment: 1,214
• Locations: 224
• Arms: 3
• Anticipated Duration (Months): 84.7
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.

Condition or Disease	Intervention/Treatment	Phase
Urothelial Carcinoma	Drug: Atezolizumab; Drug: Carboplatin; Drug: Gemcitabine; Other: Placebo; Drug: Cisplatin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1214 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
• Actual Study Start Date: Jun 30, 2016
• Anticipated Primary Completion Date: Jul 22, 2023
• Anticipated Study Completion Date: Jul 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Participants will receive blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).	Drug: Atezolizumab; Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.; Other Names: Tecentriq ; Drug: Carboplatin; Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.; Drug: Gemcitabine; Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.; Drug: Cisplatin; Cisplatin will be administered at a dose of 70 mg/m^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Placebo Comparator: Placebo+Gemcitabine+Carboplatin/Cisplatin Participants will receive blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).	Drug: Carboplatin; Carboplatin will be administered at doses to achieve area under the concentration-time curve (AUC) of 4.5 milligram per milliliter into minute (mg/mL*min) by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.; Drug: Gemcitabine; Gemcitabine will be administered at a dose of 1000 milligrams per square meter (mg/m^2) by IV infusion on Day 1 and Day 8 of each 21-day cycle, until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.; Other: Placebo; Placebo matched to atezolizumab will be administered by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.; Drug: Cisplatin; Cisplatin will be administered at a dose of 70 mg/m^2 by IV infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1 or unacceptable toxicity.
Experimental: Atezolizumab Monotherapy Eligible participants will receive open-label atezolizumab as monotherapy.	Drug: Atezolizumab; Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until investigator-assessed disease progression per RECIST v1.1. In specific circumstances treatment may continue beyond disease progression.; Other Names: Tecentriq

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Participants Treated with Atezolizumab Combination Therapy Compared With Placebo Arm [Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 44 months)]

2. Overall Survival (OS) [Baseline until death due to any cause (up to 44 months)]

3. Percentage of Participants with Adverse Events (AEs) Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [Baseline up to 44 months]

Secondary Outcome Measures

1. Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) Assessed by Investigator Using RECIST v1.1 [Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 44 months)]

2. Duration of response (DOR) Assessed by Investigator Using RECIST v1.1 [From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 44 months)]

3. IRF-PFS as determined by blinded independent central review using RECIST v1.1 [Randomization to first documented disease progression or death from any cause (up to 44 months)]

4. Percentage of Participants Who Were Alive at Year 1 [Year 1]

5. Percentage of Participants Who Were Alive and Progression Free at Year 1 Using RECIST v1.1 [Year 1]

6. Median Time to Deterioration in Global Health Status as Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score [Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 44 months)]

7. Median Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score [Cycle 1 Day 1 (cycle length = 21 days), on Day 1 of each subsequent cycle up treatment discontinuation visit (up to 44 months)]

8. Maximum Atezolizumab Serum Concentration [Pre-dose,30 min post-end of infusion(infusion length=60min) on Cycle 1 Day 1(1 cycle=21days), pre-dose on Day 1 of Cycles 2,3,4,8 and every 8th cycle thereafter(up to 44months),120 days after last dose or treatment discontinuation visit(up to 44 months)]

9. Minimum Atezolizumab Serum Concentration [Pre-dose on Day 1 (1 cycle = 21 days) of Cycles 1,2,3,4,8 and every 8th cycle thereafter (up to 44 months)]

10. Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs) [Baseline up to 44 months]

11. Investigator-Assessed Progression-Free Survival (INV-PFS) Assessed by Investigator Using RECIST v1.1 in Participants Treated with Atezolizumab Montotherapy Compared With Placebo Arm [Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 44 months)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment

• Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (</=) 2

• Histologically documented, locally advanced (T4b, any N; or any T, N2-3) or metastatic urothelial carcinoma (mUC) (M1, Stage IV) (also termed transitional cell carcinoma [TCC] or urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)

• Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment; participants who have fewer than 15 unstained slides available at baseline (but no less than [<] 10) may be eligible following discussion with the Medical Monitor

• No prior chemotherapy for inoperable locally advanced or mUC

• For participants who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval more than (>) 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting

• Prior local intravesical chemotherapy or immunotherapy is allowed if completed at least 4 weeks prior to the initiation of study treatment

• Measurable disease, as defined by RECIST v1.1

• Adequate hematologic and end-organ function

• For women of childbearing potential: agreement to remain abstinent (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 6 months after the last dose of carboplatin, cisplatin, or gemcitabine or for 5 months after the last dose of atezolizumab

• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm

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 enrolment

• Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening and prior radiographic assessments

• Participants with treated asymptomatic central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: * Evaluable or measurable disease outside the CNS * No metastases to midbrain, pons, medulla, or within 10 mm of the optic apparatus (optic nerves and chiasm) * No history of intracranial or spinal cord hemorrhage * No ongoing requirement for corticosteroid as therapy for CNS disease; anti-convulsants at a stable dose are allowed * No evidence of significant vasogenic edema * No stereotactic radiation, whole-brain radiation or neurosurgical resection within 4 weeks prior to Cycle 1, Day 1 * Radiographic demonstration of interim stability (i.e., no progression) between the completion of CNS-directed therapy and the screening radiographic study * Screening CNS radiographic study >/=4 weeks since completion of radiotherapy or surgical resection and >/=2 weeks since discontinuation of corticosteroids

• Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents

• Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1 or anticipated requirement for systemic immunosuppressive medications during the study

• Leptomeningeal disease

• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)

• Uncontrolled tumour-related pain or hypercalcemia

• Significant cardiovascular disease including known left ventricular ejection fraction (LVEF) <40%

• Severe infections within 4 weeks before randomization or therapeutic oral or IV antibiotics within 2 weeks before randomization

• Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis

• Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1

• Life expectancy of <12 weeks

• Pregnant or lactating, or intending to become pregnant during the study

• Serum albumin <25 gram per liter (g/L)

• 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

• Participants with prior allogeneic stem cell or solid organ transplantation

• History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan

• Positive test for human immunodeficiency virus (HIV)

• Active hepatitis B or hepatitis C

• Active tuberculosis

• Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Highlands Oncology Group	Springdale	Arkansas	United States	72762
2	Coastal Integrative Cancer Care	San Luis Obispo	California	United States	93401
3	Yale School of Medicine	New Haven	Connecticut	United States	06510
4	Norwalk Hospital	Norwalk	Connecticut	United States	06856
5	Christina Care Institutional Review Board	Newark	Delaware	United States	18713
6	Florida Cancer Specialists; Department of Oncology	Fort Myers	Florida	United States	33901-8101
7	UF Health Cancer Center at Orlando Health	Orlando	Florida	United States	32824
8	Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)	Saint Petersburg	Florida	United States	33705
9	Moffitt Cancer Center; GME Office	Tampa	Florida	United States	33612
10	The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology	Chicago	Illinois	United States	60637
11	Parkview Research Center	Fort Wayne	Indiana	United States	46845
12	Norton Cancer Institute	Louisville	Kentucky	United States	40202
13	East Jefferson Hematology Oncology; Hematology Oncology-Yenni Pavillion	Metairie	Louisiana	United States	70006
14	Park Nicollet Clin-Cancer Ctr	Saint Louis Park	Minnesota	United States	55426
15	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89128
16	Mount Sinai School of Medicine - Tisch Cancer Institute	New York	New York	United States	10029
17	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
18	University of North Carolina, Lineberger Cancer Ctr	Chapel Hill	North Carolina	United States	27599
19	Bon Secours - St. Francis Hospital	Greenville	South Carolina	United States	29607
20	Sarah Cannon Cancer Center	Germantown	Tennessee	United States	38138
21	Macquarie University Hospital	Macquarie Park	New South Wales	Australia	2109
22	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	4029
23	Lyell McEwin Hospital	Adelaide	South Australia	Australia	5112
24	Ashford Cancer Center Research	Kurralta Park	South Australia	Australia	5037
25	Box Hill Hospital	Box Hill	Victoria	Australia	3128
26	Cabrini Medical Centre; Oncology	Malvern	Victoria	Australia	3144
27	Sunshine Hospital; Oncology Research	St Albans	Victoria	Australia
28	GHdC Site Notre Dame	Charleroi		Belgium	6000
29	AZ Sint Lucas (Sint Lucas)	Gent		Belgium	9000
30	UZ Leuven Gasthuisberg	Leuven		Belgium	3000
31	CHC MontLégia	Liege		Belgium	4000
32	University Clinical Centre of the Republic of Srpska	Banja Luka		Bosnia and Herzegovina	78000
33	Clinic of Oncology, University Clinical Center Sarajevo	Sarajevo		Bosnia and Herzegovina	7100
34	Hospital Luxemburgo; Oncologia	Belo Horizonte	MG	Brazil	31190-131
35	CETUS Hospital Dia Oncologia	Uberaba	MG	Brazil	38082-049
36	Clinicas Oncologicas Integradas - COI	Rio De Janeiro	RJ	Brazil	22290-160
37	Hospital de Caridade de Ijui; Oncologia	Ijui	RS	Brazil	98700-000
38	Hospital das Clinicas - UFRGS	Porto Alegre	RS	Brazil	90035-903
39	Hospital Sao Lucas - PUCRS	Porto Alegre	RS	Brazil	90610-000
40	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS	Brazil	91350-200
41	Clinica Viver	Santa Maria	RS	Brazil	97015-373
42	Clinica de Neoplasias Litoral	Itajai	SC	Brazil	88301-220
43	Hospital de Base de Sao Jose do Rio Preto	Sao Jose do Rio Preto	SP	Brazil	15090-000
44	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP	Brazil	01246-000
45	Beneficencia Portuguesa de Sao Paulo	São Paulo	SP	Brazil	01321-00
46	Tom Baker Cancer Centre-Calgary; Clinical Research Unit	Calgary	Alberta	Canada	T2N 4N2
47	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
48	BC Cancer Agency, CSI	Kelowna	British Columbia	Canada	V1Y 5L3
49	Dr. Georges L. Dumont University Hospital Centre	Moncton	New Brunswick	Canada	E1C 8X3
50	Juravinski Cancer Clinic; Clinical Trials Department	Hamilton	Ontario	Canada	L8V 5C2
51	Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center	Oshawa	Ontario	Canada	L1G 2B9
52	North York General Hospital	Toronto	Ontario	Canada	M2J 1V1
53	Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas	Recoleta		Chile	8420383
54	OrlandiOncología	Santiago		Chile	7500713
55	Fundacion Arturo Lopez Perez	Santiago		Chile	7500921
56	Clinica Alemana	Vitacura		Chile	0
57	Peking Union Medical College Hospital	Beijing City		China	100032
58	Beijing Friendship Hospital	Beijing		China	100050
59	Chongqing Cancer Hospital	Chongqing		China	400030
60	Sun Yat-sen Memorial Hospital	Guangzhou		China	510000
61	Jiangsu Cancer Hospital	Nanjing City		China	211100
62	Fudan University Shanghai Cancer Center	Shanghai City		China	200120
63	Zhongshan Hospital Fudan University	Shanghai		China	200032
64	Huadong Hospital Affiliated to Fudan University	Shanghai		China	200040
65	The 2nd Hospital of Tianjin Medical University	Tianjin		China	201203
66	Masarykuv onkologicky ustav	Brno		Czechia	656 53
67	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc		Czechia	779 00
68	Vseobecna fakultni nemocnice v Praze	Praha 2		Czechia	128 08
69	University Hospital Motol; Department of Urology	Praha 5		Czechia	15006
70	East Tallinn Central Hospital	Tallinn		Estonia	10138
71	North Estonia Medical Centre Foundation; Oncology Center	Tallinn		Estonia	13419
72	Oulu University Hospital; Oncology	Oulu		Finland	90029
73	Turku Uni Central Hospital; Oncology Clinics	Turku		Finland	20520
74	Research institute for Clinical Medicine	Tbilisi		Georgia	0112
75	National Center of Urology	Tbilisi		Georgia	0144
76	Chemotherapy and Immunotherapy Clinic Medulla	Tbilisi		Georgia	0186
77	Alexandras General Hospital of Athens; Oncology Department	Athens		Greece	115 28
78	University Hospital of Patras Medical Oncology	Patras		Greece	265 04
79	Princess Margaret Hospital; Oncology	Hong Kong		Hong Kong
80	Queen Elizabeth Hospital; Clinical Oncology	Hong Kong		Hong Kong
81	Queen Mary Hospital; Dept. of Clinical Oncology	Hong Kong		Hong Kong
82	The Chinese University of Hong Kong; Department of Clinical Oncology	N.t.		Hong Kong
83	Rambam Health Care Campus; Oncology	Haifa		Israel	3109601
84	Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico	Napoli	Campania	Italy	80131
85	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna	Italy	47014
86	A.O. Universitaria Policlinico Di Modena; Oncologia	Modena	Emilia-Romagna	Italy	41100
87	Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche	Roma	Lazio	Italy	00161
88	Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical	Genova	Liguria	Italy	16132
89	ASST DI CREMONA; Dip. Medicina - S.C. Oncologia	Cremona	Lombardia	Italy	26100
90	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2	Milano	Lombardia	Italy	20133
91	Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia	Rozzano	Lombardia	Italy	20089
92	A.O CITTA' DELLA SALUTE E DELLA SCIENZA D. - Presidio San Lazzaro; Oncologia medica 2	Torino	Piemonte	Italy	10126
93	IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia	San Giovanni Rotondo	Puglia	Italy	71013
94	Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia	Arezzo	Toscana	Italy	52100
95	Azienda Ospedaliera S. Maria - Terni; Oncologia	Terni	Umbria	Italy	05100
96	IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima	Padova	Veneto	Italy	35128
97	Nagoya University Hospital	Aichi		Japan	466-8560
98	Hirosaki University Hospital	Aomori		Japan	036-8563
99	National Hospital Organization Shikoku Cancer Center	Ehime		Japan	791-0280
100	Gunma University Hospital	Gunma		Japan	371-8511
101	National Hospital Organization Hokkaido Cancer Center	Hokkaido		Japan	003-0804
102	University of Tsukuba Hospital	Ibaraki		Japan	305-8576
103	Kanazawa University Hospital	Ishikawa		Japan	920-8641
104	Kumamoto University Hospital	Kumamoto		Japan	860-8556
105	Niigata University Medical & Dental Hospital	Niigata		Japan	951-8520
106	Osaka Metropolitan University Hospital	Osaka		Japan	545-8586
107	Kindai University Hospital	Osaka		Japan	589-8511
108	Toranomon Hospital	Tokyo		Japan	105-8470
109	The Cancer Institute Hospital, JFCR; Urology	Tokyo		Japan	135-8550
110	Keio University Hospital	Tokyo		Japan	160-8582
111	Kyungpook National University Medical Center	Daegu		Korea, Republic of	41404
112	Gachon University Gil Medical Center	Incheon		Korea, Republic of	21565
113	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
114	Seoul National University Hospital	Seoul		Korea, Republic of	03080
115	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
116	Asan Medical Center	Seoul		Korea, Republic of	05505
117	Samsung Medical Center	Seoul		Korea, Republic of	06351
118	Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi	Kuala Lumpur		Malaysia	50586
119	University Malaya Medical Centre; Clinical Oncology Unit,	Kuala Lumpur		Malaysia	59100
120	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)	Mexico	03100
121	IMSS Hospital General de Zona No. 48 S. Pedro Xalpa; Departamento de Urología	Ciudad De México DF		Mexico	02710
122	Hospital San Jose; Centro de investigacion y transferencia en salud del Tec de Monterrey	Monterrey, N.L		Mexico	64710
123	Cancerología	Queretaro		Mexico	76090
124	Consultorio Médico	Zapopan, Jalisco		Mexico	45040
125	Hagaziekenhuis, locatie Leyweg	Den-Haag		Netherlands	2545 AA
126	Martini Ziekenhuis; Dept of Internal Medicine	Groningen		Netherlands	9728 NT
127	Zuyderland Medisch Centrum; Internal Diseases	Sittard-Geleen		Netherlands	6162 BG
128	Isala Klinieken, Sophia	Zwolle		Netherlands	8025 AB
129	Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej	Bialystok		Poland	15-027
130	Przychodnia Lekarska KOMED, Roman Karaszewski	Konin		Poland	62-500
131	Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii	Kraków		Poland	30-688
132	Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii	Lodz		Poland	93-513
133	Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu	Poznan		Poland	60-569
134	NU-MED Centrum Diagnostyki i Terapii Onkologicznej	Tomaszów Mazowiecki		Poland	97-200
135	Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.	Warszawa		Poland	04-073
136	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii	Wroclaw		Poland	50-556
137	Hospital de Santa Maria; Servico de Oncologia Medica	Lisboa		Portugal	1649-035
138	IPO do Porto; Servico de Oncologia Medica	Porto		Portugal	4200-072
139	Spitalul Judetean de Urgenta Dr Constantin Opris	Baia Mare		Romania	430031
140	Institute Of Oncology Bucharest; Medical Oncology	Bucharest		Romania	022338
141	Oncology Center Sf. Nectarie	Craiova		Romania	200347
142	ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic	Barnaul	Altaj	Russian Federation	656049
143	SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF	Sankt-peterburg	Leningrad	Russian Federation	197022
144	Sverdlovsk Regional Clinical Hospital 1	Ekaterinburg		Russian Federation	620102
145	Ivanovo Regional Oncology Dispensary	Ivanovo		Russian Federation	153040
146	Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy	Krasnoyarsk		Russian Federation	660133
147	Blokhin Cancer Research Center; Urological Dept	Moscow		Russian Federation	115478
148	Russian Scientific Center of Roentgenoradiology	Moscow		Russian Federation	117997
149	P.A. Herzen Oncological Inst. ; Oncology	Moscow		Russian Federation	125284
150	Privolzhsk Regional Medical Center	Nizhny Novgorod		Russian Federation	603001
151	Scientific Research Oncology Institute named after N.N. Petrov; Oncology	St. Petersburg		Russian Federation	197758
152	SBEI of HPE "Bashkir State Medical University" of MoH RF	Ufa		Russian Federation	450000
153	Clinical Center of Serbia; Clinic of Urology	Belgrade		Serbia	11000
154	Clinical Centre Nis, Clinic for Oncology	Nis		Serbia	18000
155	Oncology Institute of Vojvodina	Sremska Kamenica		Serbia	21204
156	National University Hospital; National University Cancer Institute, Singapore (NCIS)	Singapore		Singapore	119228
157	National Cancer Centre; Medical Oncology	Singapore		Singapore	169610
158	Oncocare Cancer Centre; Gleneagles Medical Centre	Singapore		Singapore
159	Institute of Oncology Ljubljana	Ljubljana		Slovenia	1000
160	GVI Oncology Outeniqua Unit; GVI Oncology Outeniqua Unit	George		South Africa	6530
161	Cancercare	Port Elizabeth		South Africa	6045
162	Wilgers Oncology Centre	Pretoria		South Africa	0001
163	Steve Biko Academic Hospital; Oncology	Pretoria		South Africa	0002
164	Sandton Oncology Medical Group	Sandton		South Africa	2196
165	Hospital General Universitario de Elche; Servicio de Oncologia	Elche	Alicante	Spain	03203
166	Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia	Badalona	Barcelona	Spain	08916
167	Institutio Catalan De Oncologia	Badalona	Barcelona	Spain	08916
168	Complejo Hospitalario de Althaia; Servicio de Oncologia	Manresa	Barcelona	Spain	08243
169	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona	Spain	8208
170	Hospital Universitario Marques de Valdecilla; Servicio de Oncologia	Santander	Cantabria	Spain	39008
171	Hospital Provincial de Castellon; Servicio de Oncologia	Castellon de La Plana	Castellon	Spain	12002
172	Hospital Universitario Reina Sofia; Servicio de Oncologia	Córdoba	Cordoba	Spain	14004
173	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares	Spain	07014
174	Clinica Universitaria de Navarra; Servicio de Oncologia	Pamplona	Navarra	Spain	31008
175	Hospital Alvaro Cunqueiro	Vigo	Pontevedra	Spain	36312
176	Hospital de Basurto; Servicio de Oncologia	Bilbao	Vizcaya	Spain	48013
177	Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia	Albacete		Spain	02006
178	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Barcelona		Spain	08035
179	Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department	Barcelona		Spain	08036
180	Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia	Barcelona		Spain	08041
181	Complejo Asistencial Universitario De Burgos; Servicio de Oncologia	Burgos		Spain	09006
182	Hospital San Pedro De Alcantara; Servicio de Oncologia	Caceres		Spain	10003
183	Hospital Universitario Virgen de las Nieves; Servicio de Oncologia	Granada		Spain	18014
184	Hospital Juan Ramon Jimenez;Servicio de Oncologia	Huelva		Spain	21005
185	Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia	Jaen		Spain	23007
186	Complejo Asistencial Universitario de Leon; Servicio de Oncologia	Leon		Spain	24071
187	Hospital Universitario Lucus Augusti	Lugo		Spain	27003
188	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid		Spain	28007
189	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid		Spain	28034
190	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Madrid		Spain	28040
191	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid		Spain	28041
192	Hospital Universitario La Paz; Servicio de Oncologia	Madrid		Spain	28046
193	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla		Spain	41013
194	Hospital Universitario de Toledo	Toledo		Spain	45007
195	Hospital Universitario la Fe; Servicio de Oncologia	Valencia		Spain	46026
196	Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia	Zaragoza		Spain	50009
197	Hospital Universitario Miguel Servet; Servicio de Oncologia Medica	Zaragoza		Spain	50009
198	Chang Gung Medical Foundation - Kaohsiung; Oncology	Kaohisung		Taiwan	833
199	China Medical University Hospital; Urology	Taichung		Taiwan	40447
200	Taichung Veterans General Hospital; Division of Urology	Taichung		Taiwan	407
201	National Cheng Kung Uni Hospital; Dept of Hematology and Oncology	Tainan		Taiwan	704
202	National Taiwan Uni Hospital; Dept of Oncology	Taipei		Taiwan	100
203	Chang Gung Medical Foundation-Linkou, Urinary Oncology	Taoyuan		Taiwan	333
204	Vajira Hospital	Bangkok		Thailand	10300
205	Chulalongkorn Hospital; Medical Oncology	Bangkok		Thailand	10330
206	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok		Thailand	10400
207	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok		Thailand	10700
208	Maharaj Nakorn Chiang Mai Hospital; Department of Medicine	ChiangMai		Thailand	50200
209	Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology	Adana		Turkey	01230
210	Ankara City Hospital	Ankara		Turkey	06490
211	Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi	Edirne		Turkey	22030
212	Bezmi Alem Vakif University Medical School; Oncology	Istanbul		Turkey	34093
213	Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani	Istanbul		Turkey	34098
214	Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology	Kadiköy		Turkey	34722
215	Medikal Park Izmir Hospital	Karşıyaka		Turkey	35575
216	19 Mayis University Medical Faculty; Medical Oncology Department	Samsun		Turkey	55139
217	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye/Ankara		Turkey	06230
218	Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4	Kharkiv	Kharkiv Governorate	Ukraine	61037
219	CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR	Dnipropetrovsk		Ukraine	49102
220	Zaporizhzhia Regional Clinic	Zaporizhzhia		Ukraine	69600
221	Beatson West of Scotland Cancer Centre	Glasgow		United Kingdom	G12 0YN
222	University College London Hospitals NHS Foundation Trust - University College Hospital	London		United Kingdom	NW1 2PG
223	The Christie NHS Foundation Trust	Manchester		United Kingdom	M20 4BX
224	The York Hospital	York		United Kingdom	YO31 8HE

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02807636
• Other Study ID Numbers: WO30070; 2016-000250-35
• First Posted: Jun 21, 2016
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by Hoffmann-La Roche: Urothelial carcinoma; Bladder cancer; Anti-PD-L1; Transitional carcinoma; Tecentriq; Atezolizumab; IMvigor130
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Gemcitabine; Carboplatin; Atezolizumab

Study Results

No Results Posted as of Jul 18, 2022