IMmotion010: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03024996
Collaborator
(none)
778
186
2
85.7
4.2
0

Study Details

Study Description

Brief Summary

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
778 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy
Actual Study Start Date :
Jan 3, 2017
Actual Primary Completion Date :
May 3, 2022
Anticipated Study Completion Date :
Feb 24, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atezolizumab

Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).

Drug: Atezolizumab
Atezolizumab 1200 mg IV infusion q3w

Placebo Comparator: Placebo

Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).

Other: Placebo
Placebo matching to atezolizumab q3w

Outcome Measures

Primary Outcome Measures

  1. Investigator-assessed DFS [From Baseline up to first occurence of event by investigator assessment (up to approximately 88 months)]

    Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurs first. Recurrence is defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS will be analyzed similarly to the analysis of IRF-assessed DFS.

Secondary Outcome Measures

  1. Overall Survival [From Baseline up to death due to any cause (up to approximately 88 months)]

  2. Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 [From Baseline until first occurrence of DFS event (up to approximately 88 months)]

  3. IRF-assessed Disease-Free Survival (DFS) [From Baseline until first documented recurrence event (up to approximately 88 months)]

    Independent Review Facility (IRF)-assessed DFS is defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurs first.

  4. IRF-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 [From Baseline until first occurrence of DFS event (up to approximately 88 months)]

    Independent Review Facility (IRF)-assessed DFS is defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurs first.

  5. IRF-assessed Event-free Survival (EFS) [From Baseline until first documented recurrence event (up to approximately 88 months)]

    IRF-assessed event-free survival (EFS) is defined as the time from randomization to death from any cause, or the first documented recurrence in patients without baseline disease by IRF or the first documented disease progression in patients identified as having baseline disease by IRF, whichever occurs first. Disease progression is defined as either unequivocal progression of baseline disease or new unequivocal lesions.

  6. Disease-Specific Survival [From Baseline up to death due to RCC (up to approximately 88 months)]

  7. Distant Metastasis-Free Survival [From Baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 88 months)]

    Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurs first

  8. Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3 [Up to 3 years]

    Recurrence assessment will be as per IRF on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.

  9. Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3 [Up to 3 years]

    Recurrence assessment will be as per investigator on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.

  10. Percentage of Participants With Adverse Events [From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 1 year)]

  11. Maximum Serum Concentration (Cmax) of Atezolizumab [Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)]

  12. Minimum Serum Concentration (Cmin) of Atezolizumab [Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)]

  13. Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab [Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ECOG performance status of less than or equal to (</=) 1

  • Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence

  • Radical or partial nephrectomy with lymphadenectomy in select participants

  • Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization. Confirmation of disease-free status will be assessed by an independent central radiologic review of imaging data.

  • Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants

  • Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery

Exclusion Criteria:
  • Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau

  • 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 or five half-lives of the investigational agent, whichever is longer, prior to enrollment

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

  • 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 HIV

  • Participants with active hepatitis B or hepatitis C

  • Active tuberculosis

  • Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia

  • 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

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

  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications

  • Prior treatment with cluster of differentiation (CD)137 agonists, 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 antibody or pathway-targeting agents

  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization

  • Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic- Scottsdale Scottsdale Arizona United States 85259
2 City of Hope National Medical Center Duarte California United States 91010
3 City of Hope, Antelope Valley Lancaster California United States 93534
4 UCLA Urology; Urology Los Angeles California United States
5 University of California Irvine Medical Center Orange California United States 92868
6 City of Hope-South Pasadena South Pasadena California United States 91030
7 City of Hope; Upland Upland California United States 91786
8 University of Colorado Cancer Center Aurora Colorado United States 80045
9 Yale School of Medicine New Haven Connecticut United States 06510
10 Florida Cancer Specialists-Broadway, Fort Myers Fort Myers Florida United States 33908
11 University of Florida Gainesville Florida United States 32607
12 Univ of Miami, School of Med; Hem/Onc Miami Florida United States 33136
13 Moffitt Cancer Center Tampa Florida United States 33612
14 Emory Uni - Winship Cancer Center; Hematology/Oncology Atlanta Georgia United States 30322
15 The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology Chicago Illinois United States 60637
16 Loyola University Medical Center, Cardinal Bernardin Cancer Center Maywood Illinois United States 60151
17 Norton Cancer Institute Louisville Kentucky United States 40202
18 Tulane Uni Health Sciences Center New Orleans Louisiana United States 70112
19 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
20 Chesapeake Urology Research Associates Towson Maryland United States 21204
21 Mayo Clinic - Rochester Rochester Minnesota United States 55905
22 Garden State Urology Whippany New Jersey United States
23 New York Oncology Hematology at Albany Medical Center Albany New York United States 12208
24 Bellevue Hospital New York New York United States 10016
25 Laura and ISAAC Perlmutter Cancer Center at NYU Langone. New York New York United States 10016
26 Mount SInai Medical Center New York New York United States 10029
27 University of Rochester Medical Center; Urology Rochester New York United States 14642
28 SUNY Upstate Medical University Syracuse New York United States 13210
29 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27514
30 Levine Cancer Institute Charlotte North Carolina United States 28204
31 Fairview Hospital; Cleveland Clinic Cancer Center Cleveland Ohio United States 44111
32 Cleveland Clinic Foundation; Hematology and Oncology Cleveland Ohio United States 44195
33 Hillcrest Hospital; Hirsch Cancer Center Mayfield Heights Ohio United States 44124
34 University of Oklahoma; Stephenson Oklahoma Canc Ctr Oklahoma City Oklahoma United States 73104
35 Oregon Health & Science Uni Portland Oregon United States 97239
36 Fox Chase Cancer Center; Hematology/Oncology Philadelphia Pennsylvania United States 19111
37 Sanford Cancer Cnt Onco Clinic Sioux Falls South Dakota United States 57104
38 Erlanger Health Systems Chattanooga Tennessee United States 37403
39 Urology Associates of Kingsport, P.C. Kingsport Tennessee United States 37660
40 Sarah Cannon Research Institute Nashville Tennessee United States 37203
41 Vanderbilt University Medical Center; Vanderbilt University Nashville Tennessee United States 37232
42 University of Texas Southwestern Medical Center Dallas Texas United States 75390
43 MD Anderson Cancer Center Houston Texas United States 77030-4095
44 University of Utah; Huntsman Cancer Hospital Salt Lake City Utah United States 84112
45 West Virginia University Hospitals Inc Morgantown West Virginia United States 26056
46 Hospital Britanico; Oncologia Buenos Aires Argentina C1280AEB
47 Hospital Aleman Caba Argentina C1118AAT
48 Centro Oncologico Riojano Integral (CORI) La Rioja Argentina F5300COE
49 Calvary Mater Newcastle; Medical Oncology Waratah New South Wales Australia 2298
50 Royal Brisbane & Women's Hosp; Cancer Care Serv Herston Queensland Australia 4029
51 Ashford Cancer Center Research Kurralta Park South Australia Australia 5037
52 Austin Hospital; Medical Oncology Heidelberg Victoria Australia 3084
53 Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie Linz Austria 4020
54 Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU Salzburg Austria 5020
55 Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome Wien Austria 1090
56 Cliniques Universitaires St-Luc Bruxelles Belgium 1200
57 UZ Leuven Gasthuisberg Leuven Belgium 3000
58 Hospital Erasto Gaertner Curitiba PR Brazil 81520-060
59 Hospital das Clinicas - UFRGS Porto Alegre RS Brazil 90035-903
60 Hospital Sao Lucas - PUCRS Porto Alegre RS Brazil 90610-000
61 Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP Brazil 01246-000
62 Hospital Alemao Oswaldo Cruz Sao Paulo SP Brazil 01323-903
63 Tom Baker Cancer Centre-Calgary Calgary Alberta Canada T2N 4N2
64 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
65 BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre) Kelowna British Columbia Canada V1Y 5L3
66 Queen Elizabeth II Health Sciences Centre; Oncology Halifax Nova Scotia Canada B3H 2Y9
67 The Ottawa Hospital Cancer Centre; Oncology Ottawa Ontario Canada K1H 8L6
68 North York General Hospital; Inpatient Pharmacy Toronto Ontario Canada M2K 1E1
69 Sunnybrook Odette Cancer Centre Toronto Ontario Canada M4N 3M5
70 Princess Margaret Cancer Center Toronto Ontario Canada M5G 1Z5
71 McGill University Health Centre - Glen Site Montreal Quebec Canada H4A 3J1
72 Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont Sherbrooke Quebec Canada J1H 5N4
73 Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec Quebec Canada G1R 3S1
74 Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas Recoleta Chile 8420383
75 Sociedad de Investigaciones Medicas Ltda (SIM) Temuco Chile 4810469
76 ONCOCENTRO APYS; Oncología Vina Del Mar Chile 2520598
77 Jiangsu Cancer Hospital Nanjing City China 211100
78 Fudan University Shanghai Cancer Center; Medical Oncology Shanghai City China 201315
79 Masarykuv onkologicky ustav Brno Czechia 656 53
80 Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc Czechia 779 00
81 General University Hospital; CLINIC OF ONCOLOGY Praha 2 Czechia 128 08
82 Thomayerova nemocnice Praha 4 - Krc Czechia 140 59
83 Aarhus Universitetshospital; Kræftafdelingen Aarhus N Denmark 8200
84 Herlev Hospital; Afdeling for Kræftbehandling Herlev Denmark 2730
85 CHU d'Angers Angers France 49033
86 CHU Henri Mondor; Service d'Oncologie Medicale Creteil France 94010
87 CHU de Nantes - Hotel Dieu Nantes France 44093
88 Institut Mutualiste Montsouris; Oncologie Paris France 75674
89 CHU Pontchaillou Rennes France 35000
90 CHU de Rouen - Hôpital Charles Nicolle Rouen France 76031
91 Nouvel Hopital Civil - CHU Strasbourg; Urologie Strasbourg France 67091
92 Institut Gustave Roussy Villejuif France 94805
93 Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie Dresden Germany 01307
94 Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie Hannover Germany 30625
95 Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen Heidelberg Germany 69120
96 Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie Homburg/Saar Germany 66424
97 Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik München Germany 81675
98 Universitätsklinikum Tübingen; Klinik für Urologie Tübingen Germany 72076
99 Cork Uni Hospital; Oncology Dept Cork Ireland
100 Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit Dublin Ireland 24
101 Soroka Medical Center; Oncology Dept Beer Sheva Israel 8410100
102 Rambam Health Care Campus; Oncology Haifa Israel 3109601
103 Hadassah Ein Karem Hospital; Oncology Dept Jerusalem Israel 9112000
104 Meir Medical Center; Oncology Kfar-Saba Israel 4428164
105 Belinson Medical Center, Division of Oncology Petach Tikva Israel 4941492
106 Chaim Sheba medical center, Oncology division Ramat Gan Israel 5262000
107 Sourasky Medical Center; Oncology Department Tel-Aviv Israel 6423900
108 Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica Bologna Emilia-Romagna Italy 40138
109 IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Meldola Emilia-Romagna Italy 47014
110 A.O. Universitaria Policlinico Di Modena; Oncologia Modena Emilia-Romagna Italy 41100
111 Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 Milano Lombardia Italy 20133
112 Fondazione IRCCS Policlinico San Matteo, Oncologia Pavia Lombardia Italy 27100
113 Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia Arezzo Toscana Italy 52100
114 IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima Padova Veneto Italy 35128
115 Nagoya University Hospital Aichi Japan 466-8560
116 Hirosaki University Hospital Aomori Japan 036-8563
117 Kyushu University Hospital Fukuoka Japan 812-8582
118 Kobe University Hospital Hyogo Japan 650-0017
119 University of Tsukuba Hospital Ibaraki Japan 305-8576
120 Mie University Hospital Mie Japan 514-8507
121 Niigata University Medical & Dental Hospital Niigata Japan 951-8520
122 Okayama University Hospital Okayama Japan 700-8558
123 Jichi Medical University Hospital Tochigi Japan 329-0498
124 Tokushima University Hospital Tokushima Japan 770-8503
125 Toranomon Hospital Tokyo Japan 105-8470
126 Tokyo Medical and Dental University Hospital Tokyo Japan 113-8519
127 Nippon Medical School Hospital Tokyo Japan 113-8603
128 Tokyo Women's Medical University Adachi Medical Center Tokyo Japan 123-8558
129 The Cancer Institute Hospital of JFCR Tokyo Japan 135-8550
130 Keio University Hospital Tokyo Japan 160-8582
131 National Cancer Center Goyang-si Korea, Republic of 10408
132 Asan Medical Center Seoul Korea, Republic of 05505
133 Samsung Medical Center Seoul Korea, Republic of 06351
134 VU Medisch Centrum; VU University Medical Center Amsterdam Netherlands 1007 MB
135 Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis Amsterdam Netherlands 1066 CX
136 UMC Radboud Nijmegen Nijmegen Netherlands 6500 HB
137 Sint Franciscus Gasthuis; Inwendige Geneeskunde Rotterdam Netherlands 3045 PM
138 St. Antonius locatie Leidsche Rijn Utrecht Netherlands 3543 AZ
139 Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii Kraków Poland 30-688
140 Narodowy Inst.Onkol.im.Skłodowskiej-Curie Państw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej Kraków Poland 31-115
141 Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli Lublin Poland 20-090
142 Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu; Oddział Chemioterapii Poznań Poland 60-569
143 Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. Warszawa Poland 04-073
144 Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw Poland 50-556
145 Altai Region Oncology Dispensory; Oncology Barnaul Russian Federation 656049
146 Sverdlovsk Regional Clinical Hospital 1 Ekaterinburg Russian Federation 620102
147 P.A. Herzen Oncological Inst. ; Oncology Moscow Russian Federation 125284
148 City Clinical Oncology Hospital Moscow Russian Federation 143423
149 Privolzhsk Regional Medical Center Nizhny Novgorod Russian Federation 603001
150 City Clinical Oncology Dispensary Saint-Petersburg Russian Federation 197022
151 Clinic for Urology, Clinical Center of Serbia; Clinic for Urology Belgrade Serbia 11000
152 Clinic for Urology; Military Medical Academy Belgrade Serbia 11000
153 Oncology Institute of Vojvodina Sremska Kamenica Serbia 21204
154 Hospital Univ. Central de Asturias; Servicio de Oncologia Oviedo Asturias Spain 33011
155 Hospital Universitario Reina Sofia; Servicio de Oncologia Córdoba Cordoba Spain 14004
156 Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Santiago de Compostela LA Coruña Spain 15706
157 Hospital Univ Vall d'Hebron; Servicio de Oncologia Barcelona Spain 08035
158 Hospital Clínic i Provincial; Servicio de Oncología Barcelona Spain 08036
159 Institut Catala d Oncologia Hospital Duran i Reynals Barcelona Spain 08908
160 Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Madrid Spain 28007
161 Hospital Ramon y Cajal; Servicio de Oncologia Madrid Spain 28034
162 Hospital Universitario Clínico San Carlos; Servicio de Oncologia Madrid Spain 28040
163 Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid Spain 28041
164 China Medical University Hospital; Urology Taichung Taiwan 40447
165 Taichung Veterans General Hospital; Division of Urology Taichung Taiwan 407
166 National Taiwan University Hospital, Department of Urology Taipei Taiwan 10048
167 TAIPEI VETERANS GENERAL HOSPITAL, Urology Taipei Taiwan 11217
168 Chang Gung Medical Foundation-Linkou, Urinary Oncology Taoyuan Taiwan 333
169 Division of Urological surgery; Department of surgery, Chulalongkorn University Bangkok Thailand 10330
170 Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit Chiangmai Thailand 50200
171 Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology Adana Turkey 01230
172 Gazi University Medical Faculty; Department of İnternal Medicine Ankara Turkey 06500
173 Ankara Uni School of Medicine; Medical Oncology Ankara Turkey 06590
174 Trakya University Medical Faculty Edirne Turkey 22030
175 Hacettepe Uni Medical Faculty Hospital; Oncology Dept Sihhiye/Ankara Turkey 06230
176 Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4 Kharkiv Kharkiv Governorate Ukraine 61037
177 CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR Dnipropetrovsk Ukraine 49102
178 Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction Lviv Ukraine 79034
179 Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary Sumy Ukraine 40005
180 Zaporizhzhia Regional Clinic Zaporizhzhia Ukraine 69600
181 Leicester Royal Infirmary Leicester United Kingdom LE1 5WW
182 Royal Free Hospital London United Kingdom NW3 2QS
183 Christie Hospital Manchester United Kingdom M20 3BG
184 Freeman Hospital Newcastle upon Tyne United Kingdom NE7 7DN
185 Weston Park Hospital Sheffield United Kingdom S10 2SJ
186 Singleton Hospital; Pharmacy Department Swansea United Kingdom SA2 8QA

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:
NCT03024996
Other Study ID Numbers:
  • WO39210
  • 2016-001881-27
First Posted:
Jan 19, 2017
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022