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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03024996
Recruitment Status : Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : December 18, 2019
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Renal Cell Carcinoma Drug: Atezolizumab Other: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : January 3, 2017
Estimated Primary Completion Date : May 24, 2022
Estimated Study Completion Date : April 13, 2024

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

Primary Outcome Measures :
  1. IRF-assessed Disease-Free Survival (DFS) [ Time Frame: 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 the earliest death from any cause or the first documented recurrence event assessed by IRF, defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Tumor assessment will be as per IRF on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From Baseline up to death due to any cause (up to approximately 88 months) ]
  2. Investigator-assessed DFS [ Time Frame: From Baseline up to first occurence of event by investigator assessment (up to approximately 88 months) ]
    Investigator-assessed DFS is defined as the time from randomization to the first occurrence of a DFS event by investigator assessment. Investigator-assessed DFS will be analyzed similarly to the analysis of IRF-assessed DFS.

  3. IRF-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3 [ Time Frame: 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 the earliest death from any cause or the first documented recurrence event assessed by IRF, defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Tumor assessment will be as per IRF on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.

  4. Investigator-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3 [ Time Frame: From Baseline until first occurrence of DFS event (up to approximately 88 months) ]
  5. Disease-Specific Survival [ Time Frame: From Baseline up to death due to RCC (up to approximately 88 months) ]
  6. Distant Metastasis-Free Survival [ Time Frame: 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 the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator or death from any cause

  7. Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 3 [ Time Frame: Year 3 ]
    Recurrence assessment will be as per IRF on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.

  8. Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 3 [ Time Frame: Year 3 ]
    Recurrence assessment will be as per investigator on the basis of radiographic evidence and whenever possible supported/confirmed by biopsy results.

  9. Percentage of Participants With Adverse Events [ Time Frame: 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) ]
  10. Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: 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) ]
  11. Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: 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. Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab [ Time Frame: 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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03024996

Hide Hide 186 study locations
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United States, Arizona
Mayo Clinic- Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
City of Hope, Antelope Valley
Lancaster, California, United States, 93534
UCLA Urology; Urology
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States, 92868
City of Hope-South Pasadena
South Pasadena, California, United States, 91030
City of Hope; Rancho Cucamonga
Upland, California, United States, 91786
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
Florida Cancer Specialists-Broadway, Fort Myers
Fort Myers, Florida, United States, 33908
University of Florida
Gainesville, Florida, United States, 32607
Univ of Miami, School of Med; Hem/Onc
Miami, Florida, United States, 33136
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory Uni - Winship Cancer Center; Hematology/Oncology
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
Chicago, Illinois, United States, 60637
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60151
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane Uni Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, New Jersey
Garden State Urology
Whippany, New Jersey, United States
United States, New York
New York Oncology Hematology at Albany Medical Center
Albany, New York, United States, 12208
Bellevue Hospital
New York, New York, United States, 10016
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States, 10016
Mount SInai Medical Center
New York, New York, United States, 10029
University of Rochester Medical Center; Urology
Rochester, New York, United States, 14642
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
United States, Ohio
Fairview Hospital; Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation; Hematology and Oncology
Cleveland, Ohio, United States, 44195
Hillcrest Hospital; Hirsch Cancer Center
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
University of Oklahoma; Stephenson Oklahoma Canc Ctr
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Science Uni
Portland, Oregon, United States, 97239
United States, Pennsylvania
Fox Chase Cancer Center; Hematology/Oncology
Philadelphia, Pennsylvania, United States, 19111
United States, South Dakota
Sanford Cancer Cnt Onco Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Erlanger Health Systems
Chattanooga, Tennessee, United States, 37403
Urology Associates of Kingsport, P.C.
Kingsport, Tennessee, United States, 37660
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center; Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4095
United States, Utah
University of Utah; Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112
United States, West Virginia
West Virginia University Hospitals Inc
Morgantown, West Virginia, United States, 26056
Hospital Britanico; Oncologia
Buenos Aires, Argentina, C1280AEB
Hospital Aleman
Caba, Argentina, C1118AAT
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina, F5300COE
Australia, New South Wales
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Royal Brisbane & Women's Hosp; Cancer Care Serv
Herston, Queensland, Australia, 4029
Australia, South Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Austin Hospital; Medical Oncology
Heidelberg, Victoria, Australia, 3084
Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
Linz, Austria, 4020
Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
Salzburg, Austria, 5020
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
Wien, Austria, 1090
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Hospital Erasto Gaertner
Curitiba, PR, Brazil, 81520-060
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-903
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Hospital Alemao Oswaldo Cruz
Sao Paulo, SP, Brazil, 01323-903
Canada, Alberta
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Bcca - Cancer Center Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, Canada, K1H 8L6
North York General Hospital; Inpatient Pharmacy
Toronto, Ontario, Canada, M2K 1E1
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 1Z5
Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
CHUS (Centre Hospitalier Universitaire de Sherbrooke)
Sherbrooke, Quebec, Canada, J1H 5N4
Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
Quebec, Canada, G1R 3S1
Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
Recoleta, Chile, 8420383
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco, Chile, 4810469
Vina Del Mar, Chile, 2520598
Jiangsu Cancer Hospital
Nanjing, China, 210009
Fudan University Shanghai Cancer Center; Medical Oncology
Shanghai, China, 200032
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
General University Hospital; CLINIC OF ONCOLOGY
Praha 2, Czechia, 128 08
Thomayerova nemocnice
Praha 4 - Krc, Czechia, 140 59
Aarhus Universitetshospital; Kræftafdelingen
Aarhus N, Denmark, 8200
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, Denmark, 2730
CHU d'Angers
Angers, France, 49033
CHU Henri Mondor; Service d'Oncologie Medicale
Creteil, France, 94010
CHU de Nantes - Hotel Dieu
Nantes, France, 44093
Institut Mutualiste Montsouris; Oncologie
Paris, France, 75674
CHU Pontchaillou
Rennes, France, 35000
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France, 76031
Nouvel Hopital Civil - CHU Strasbourg; Urologie
Strasbourg, France, 67091
Institut Gustave Roussy
Villejuif, France, 94805
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Dresden, Germany, 01307
Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
Hannover, Germany, 30625
Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
Heidelberg, Germany, 69120
Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
Homburg/Saar, Germany, 66424
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München, Germany, 81675
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, Germany, 72076
Cork Uni Hospital; Oncology Dept
Cork, Ireland
Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
Dublin, Ireland, 24
Soroka Medical Center; Oncology Dept
Beer Sheva, Israel, 8410100
Rambam Health Care Campus; Oncology
Haifa, Israel, 3109601
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel, 9112000
Meir Medical Center; Oncology
Kfar-Saba, Israel, 4428164
Belinson Medical Center, Division of Oncology
Petach Tikva, Israel, 4941492
Chaim Sheba medical center, Oncology division
Ramat Gan, Israel, 5262000
Sourasky Medical Center; Oncology Department
Tel-Aviv, Israel, 6423900
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40138
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy, 47014
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, Italy, 41100
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano, Lombardia, Italy, 20133
Fondazione IRCCS Policlinico San Matteo, Oncologia
Pavia, Lombardia, Italy, 27100
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Arezzo, Toscana, Italy, 52100
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
Padova, Veneto, Italy, 35128
Nagoya University Hospital
Aichi, Japan, 466-8560
Hirosaki University Hospital
Aomori, Japan, 036-8563
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Kobe University Hospital
Hyogo, Japan, 650-0017
University of Tsukuba Hospital
Ibaraki, Japan, 305-8576
Mie University Hospital
Mie, Japan, 514-8507
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Okayama University Hospital
Okayama, Japan, 700-8558
Jichi Medical University Hospital
Tochigi, Japan, 329-0498
Tokushima University Hospital
Tokushima, Japan, 770-8503
Toranomon Hospital
Tokyo, Japan, 105-8470
Tokyo Medical & Dental University Hospital
Tokyo, Japan, 113-8519
Nippon Medical School Hospital
Tokyo, Japan, 113-8603
Tokyo Women's Medical University Medical Center East
Tokyo, Japan, 116-8567
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Keio University Hospital
Tokyo, Japan, 160-8582
Korea, Republic of
National Cancer Center
Gyeonggi-do, Korea, Republic of, 10408
Asan Medical Center - Oncology
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
VU Medisch Centrum; VU University Medical Center
Amsterdam, Netherlands, 1007 MB
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
UMC Radboud Nijmegen
Nijmegen, Netherlands, 6500 HB
Sint Franciscus Gasthuis; Inwendige Geneeskunde
Rotterdam, Netherlands, 3045 PM
St. Antonius locatie Leidsche Rijn
Utrecht, Netherlands, 3543 AZ
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, Poland, 31-531
Klinika Onkologii Klinicznej CO-I Kraków
Krakow, Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin, Poland, 20-090
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, Poland, 60-570
Saint Elizabeth's Hospital
Warsaw, Poland, 02-616
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland, 50-556
Russian Federation
Altai Region Oncology Dispensory; Oncology
Barnaul, Russian Federation, 656049
Sverdlovsk Regional Clinical Hospital 1
Ekaterinburg, Russian Federation, 620102
P.A. Herzen Oncological Inst. ; Oncology
Moscow, Russian Federation, 125284
City Clinical Oncology Hospital
Moscow, Russian Federation, 143423
Privolzhsk Regional Medical Center
Nizhny Novgorod, Russian Federation, 603001
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
Belgrade, Serbia, 11000
Clinic for Urology; Military Medical Academy
Belgrade, Serbia, 11000
Oncology Institute of Vojvodina
Sremska Kamenica, Serbia, 21204
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Asturias, Spain, 33011
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain, 14004
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, Spain, 08036
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, Spain, 08908
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
China Medical University Hospital; Urology
Taichung, Taiwan, 40447
Taichung Veterans General Hospital; Division of Urology
Taichung, Taiwan, 407
National Taiwan University Hospital, Department of Urology
Taipei, Taiwan, 10048
Taipei, Taiwan, 11217
Chang Gung Medical Foundation-Linkou, Urinary Oncology
Taoyuan, Taiwan, 333
Division of Urological surgery; Department of surgery, Chulalongkorn University
Bangkok, Thailand, 10330
Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
Chiangmai, Thailand, 50200
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, Turkey, 01250
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ankara, Turkey, 06100
Gazi University Medical Faculty; Department of İnternal Medicine
Ankara, Turkey, 06500
Ankara Uni School of Medicine; Medical Oncology
Ankara, Turkey, 06590
Trakya University Medical Faculty
Edirne, Turkey, 22030
Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
Kharkiv, Kharkiv Governorate, Ukraine, 61037
CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
Dnipropetrovsk, Ukraine, 49102
Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction
Lviv, Ukraine, 79034
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
Sumy, Ukraine, 40005
Zaporizhzhia Regional Clinic
Zaporizhzhia, Ukraine, 69600
United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Royal Free Hospital
London, United Kingdom, NW3 2QS
Christie Hospital
Manchester, United Kingdom, M20 3BG
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Singleton Hospital; Pharmacy Department
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT03024996    
Other Study ID Numbers: WO39210
2016-001881-27 ( EudraCT Number )
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs