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Trial record 1 of 1 for:    NCT02420821
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A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma [IMmotion151]

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02420821
First received: April 15, 2015
Last updated: May 5, 2017
Last verified: May 2017
  Purpose
This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.

Condition Intervention Phase
Renal Cell Carcinoma Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Drug: Bevacizumab Drug: Sunitinib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in Participants with Detectable Programmed Death-Ligand 1 (PD-L1) [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • Overall Survival (OS) in all Randomized Participants [ Time Frame: Baseline until death due to any cause (up to 63 months) ]

Secondary Outcome Measures:
  • OS in Participants with Detectable PD-L1 [ Time Frame: Baseline until death due to any cause (up to 63 months) ]
  • PFS as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • DOR as Determined by an IRC According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • PFS as Determined by the Investigator According to Modified RECIST [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Modified RECIST [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • DOR as Determined by the Investigator According to Modified RECIST [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • PFS in All Randomized Participants as Determined by the Investigator According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • PFS in Participants With Sarcomatoid Histology as Determined by the Investigator According to RECIST v1.1 [ Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months]) ]
  • OS in Participants With Sarcomatoid Histology [ Time Frame: Baseline until death due to any cause (up to 63 months) ]
  • Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II [ Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days) ]
  • Change From Baseline in Symptom Severity as Determined by MDASI [ Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days) ]
  • Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) [ Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle and weekly during the first 12 weeks, up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days) ]
  • Change From Baseline in Treatment Side Effects Subscale From Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) [ Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days) ]
  • Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Scores [ Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days) ]
  • Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) [ Time Frame: Baseline up to 63 months ]
  • Percentage of Participants With Anti--Therapeutic Antibodies (ATAs) Against Atezolizumab [ Time Frame: Baseline up to 63 months (assessed at pre-dose [Hour 0] on Day 1 of Cycles 1, 2, 4, 8, and every 8 cycles thereafter up to treatment discontinuation [up to 63 months] , and 120 days after last dose [up to 63 months]) (Cycle = 42 days) ]
  • Maximum Serum Concentration (Cmax) for Atezolizumab [ Time Frame: 30 minutes after the end of atezolizumab infusion (infusion duration: 30-60 minutes) on Cycle 1, Day 1 (Cycle = 42 days) ]
  • Minimum Serum Concentration (Cmin) for Atezolizumab [ Time Frame: Pre-dose (Hour 0) on Days 1 and 22 of Cycles 1, 2, and 4; pre-dose (Hour 0) on Day 1 of Cycle 8 and every 8 cycles thereafter up to treatment discontinuation (up to 63 months), and 120 days after last dose (up to 63 months) (Cycle = 42 days) ]
  • Cmax for Bevacizumab [ Time Frame: 30 minutes after the end of atezolizumab infusion (infusion duration: 30-90 minutes) on Cycle 1, Day 1 and Cycle 3, Day 1 (Cycle = 42 days) ]
  • Cmin for Bevacizumab [ Time Frame: Pre-dose (Hour 0) on Cycle 1, Day 1 and Cycle 3, Day 1, at the treatment discontinuation (up to 63 months), and 120 days after last dose (up to 63 months) (Cycle = 42 days) ]

Enrollment: 915
Actual Study Start Date: May 31, 2015
Estimated Study Completion Date: July 31, 2020
Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atezolizumab + Bevacizumab
Participants assigned to a dual regimen of atezolizumab plus bevacizumab will receive both agents until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Days 1 and 22 of each 42-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.
Other Name: Tecentriq, MPDL3280A
Drug: Bevacizumab
Bevacizumab as 15 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 22 of each 42-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.
Other Name: Avastin
Active Comparator: Sunitinib
Participants assigned to receive sunitinib single-agent chemotherapy will receive treatment until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Drug: Sunitinib
Sunitinib as 50 mg orally, once daily on Days 1 through 28 of each 42-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.
Other Name: Sutent

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Definitive diagnosis of unresectable locally advanced or metastatic RCC with clear-cell histology and/or a component of sarcomatoid carcinoma, with no prior treatment in the metastatic setting
  • Evaluable Memorial Sloan Kettering Cancer Center risk score
  • Measurable disease, as defined by RECIST v1.1
  • Karnofsky performance status greater than or equal to 70%
  • Adequate hematologic and end-organ function prior to randomization

Exclusion Criteria:

Disease-Specific Exclusions:

  • Radiotherapy for RCC within 14 days prior to treatment
  • Active central nervous system disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites
  • Uncontrolled hypercalcemia
  • Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death

General Medical Exclusions:

  • Life expectancy less than 12 weeks
  • Participation in another experimental drug study within 4 weeks prior to treatment
  • Pregnant or lactating women
  • Known hypersensitivity to any component of atezolizumab or other study medication
  • History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
  • Positive human immunodeficiency virus test
  • Active or chronic hepatitis B or C
  • Severe infections within 4 weeks prior to treatment
  • Exposure to oral or IV antibiotics within 2 weeks prior to treatment
  • Live attenuated vaccines within 4 weeks prior to treatment, 28 days prior to randomization, during treatment, or within 5 months following last dose of atezolizumab
  • Significant cardiovascular disease
  • Prior allogeneic stem cell or solid organ transplantation

Exclusion Criteria Related to Medications:

  • Prior treatment with cluster of differentiation 137 agonists, anti-cytotoxic T-lymphocyte associated protein-4, anti-programmed death (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
  • Treatment with immunostimulatory agents for non-malignant conditions within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment

Bevacizumab- and Sunitinib-Specific Exclusions:

  • History of hypertensive crisis or hypertensive encephalopathy
  • Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02420821

  Hide Study Locations
Locations
United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
United States, California
University of California at Irvine Medical Center; Department of Oncology
Orange, California, United States, 92868
University of California
San Francisco, California, United States, 94158
United States, Colorado
University of Colorado; Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Center; Medical Oncology
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown U; Lombardi Comp Can
Washington, D.C., District of Columbia, United States, 20016-1468
United States, Florida
Lynn Cancer Institute/Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Florida Cancer Specialists - Port Charlotte
Port Charlotte, Florida, United States, 33980
Florida Cancer Specialist, North Region
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists
West Palm Beach, Florida, United States, 33401
United States, Georgia
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States, 30318
Central Georgia Cancer Care PC
Macon, Georgia, United States, 31201
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States, 30060
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40402
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Inst.
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Nevada
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
New York Oncology Hematology,P.C.-Albany
Albany, New York, United States, 12208
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
United States, Ohio
Oncology Hematology Care Inc
Cincinnati, Ohio, United States, 45242
Cleveland Clinic Foundation; Taussig Cancer Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Compass Oncology, The Northwest Cancer Specialists - Compass Oncology Tualatin
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Cancer Center and Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt Univ Medical Ctr
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology-Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, United States, 76104
United States, Virginia
Oncology and Hematology Associates of SW Virginia-Raonoke
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, New South Wales
Lifehouse
Camperdown, New South Wales, Australia, 2050
Macquarie University Hospital
Macquarie University, New South Wales, Australia, 2109
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Icon Cancer Foundation
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Austin Hospital; Medical Oncology
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
St John of God Hospital
Murdoch, Western Australia, Australia, WA6150
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina, 78000
Brazil
Hospital de Caridade de Ijui; Oncologia
Ijui, RS, Brazil, 98700-000
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90020-090
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
Canada, Nova Scotia
QEII HSC; Oncology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Royal Victoria Hospital
Barrie, Ontario, Canada, L4M 6M2
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
Canada
Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
Quebec, Canada, G1R 3S1
Czechia
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Praha 2, Czechia, 128 08
Thomayerova nemocnice
Praha 4 - Krc, Czechia, 140 59
Denmark
Aarhus Universitetshospital; Kræftafdelingen
Aarhus C, Denmark, 8000
Herlev Hospital; Onkologisk afdeling
Herlev, Denmark, 2730
Odense Universitetshospital, Onkologisk Afdeling R
Odense, Denmark, 5000
France
ICO Paul Papin; Oncologie Medicale.
Angers, France, 49055
Hopital Saint Andre; Oncologie 2
Bordeaux, France, 33075
Centre Francois Baclesse; Urologie Gynecologie
Caen, France, 14076
Centre Oscar Lambret
Lille, France, 59020
Centre Léon Bérard
Lyon, France, 69373
Institut Paoli Calmettes; Oncologie Medicale
Marseille, France, 13273
Centre D'Oncologie de Gentilly; Oncology
Nancy, France, 54100
APHP - Hospital Saint Louis
Paris, France, 75475
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
Paris, France, 75908
ICO - Site René Gauducheau
Saint Herblain, France, 44805
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, France, 94805
Germany
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Dresden, Germany, 01307
Universitaetsklinikum Essen, Innere Klinik und Poliklinik fuer Tumorforschung
Essen, Germany, 45122
Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
Heidelberg, Germany, 69120
Klinikum d.Universität München Campus Großhadern
München, Germany, 81377
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen, Germany, 72076
Italy
Az. Osp. Cardarelli; Divisione Di Oncologia
Napoli, Campania, Italy, 80131
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
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Roma, Lazio, Italy, 00152
Irccs Ospedale San Raffaele;Oncologia Medica
Milano, Lombardia, Italy, 20132
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milano, Lombardia, Italy, 20162
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
Japan
Nagoya University Hospital; Urology
Aichi, Japan, 466-8560
Chiba Cancer Center
Chiba, Japan, 260-0801
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Gunma University Hospital
Gunma, Japan, 371-8511
Hokkaido University Hospital
Hokkaido, Japan, 060-8648
University of Tsukuba Hospital; Urology
Ibaraki, Japan, 305-8576
Iwate Medical University Hospital
Iwate, Japan, 020-8505
Yokohama City University Hospital
Kanagawa, Japan, 236-0004
Kitasato University Hospital
Kanagawa, Japan, 252-0375
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Okayama University Hospital
Okayama, Japan, 700-8558
Osaka International Cancer Institute; Urology
Osaka, Japan, 541-8567
Osaka City University Hospital
Osaka, Japan, 545-8586
Osaka University Hospital
Osaka, Japan, 565-0871
Kinki University Hospital
Osaka, Japan, 589-8511
Saitama Medical University International Medical Center
Saitama, Japan, 350-1298
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
The Cancer Institute Hospital, JFCR; Urology
Tokyo, Japan, 135-8550
Keio University Hospital
Tokyo, Japan, 160-8582
Tokyo Women's Medical University
Tokyo, Japan, 162-0054
Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of, 35015
National Cancer Center
Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Mexico
Cancerología
Queretaro, Mexico, 76090
Centro Oncologico Estatal ISSEMYM
Toluca, Mexico, 50180
Poland
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, Poland, 85-796
Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii
Lodz, Poland, 93-513
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin, Poland, 20-090
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
Poznan, Poland, 60-569
Saint Elizabeth's Hospital
Warsaw, Poland, 02-616
Centrum Med. Ostrobramska NZOZ Magodent
Warszawa, Poland, 04-125
Russian Federation
ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
Barnaul, Altaj, Russian Federation, 656049
GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
Nizhni Novgorod, Niznij Novgorod, Russian Federation, 603001
P.A. Herzen Oncological Inst. ; Oncology
Moscow, Russian Federation, 125284
Moscow city oncology hospital #62 of Moscow Healthcare Department
Moscow, Russian Federation, 143423
Singapore
National University Hospital
Singapore, Singapore, 119074
National Cancer Centre; Medical Oncology
Singapore, Singapore, 169610
Oncocare Cancer Centre
Singapore, Singapore, 258499
Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain, 08208
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Oncología
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Spain, 08041
Hospital Duran i Reynals; Oncologia
Barcelona, Spain, 08907
Hospital Universitario Reina Sofia; Servicio de Oncologia
Cordoba, Spain, 14004
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, Spain, 41013
Taiwan
Taichung Veterans General Hospital; Division of Urology
Taichung, Taiwan, 407
National Taiwan Uni Hospital; Dept of Oncology
Taipei, Taiwan, 100
Chang Gung Medical Foundation-Linkou, Urinary Oncology
Taoyuan, Taiwan, 333
Thailand
Chulalongkorn Hospital; Medical Oncology
Bangkok, Thailand, 10330
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, Thailand, 10400
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, Thailand, 10700
Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
Chiangmai, Thailand, 50200
Prince of Songkla Uni ; Unit of Medical Oncology
Songkhla, Thailand, 90110
Turkey
Hacettepe University Medical Faculty
Ankara, Turkey, 6100
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, Turkey, 22770
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, Turkey, 34300
United Kingdom
Clatterbridge Cancer Centre
Bebington, United Kingdom, CH63 4JY
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Royal Blackburn Hospital
Blackburn, United Kingdom, BB2 3HH
Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
Cambridge, United Kingdom, CB2 0QQ
Barts Health NHS Trust - St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Royal Free Hospital; Dept of Oncology
London, United Kingdom, NW3 2QG
Royal Marsden Hospital; Dept of Med-Onc
London, United Kingdom, SW3 6JJ
Christie Hospital Nhs Trust; Medical Oncology
Manchester, United Kingdom, M2O 4BX
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, United Kingdom, OX3 7LJ
Southampton General Hospital; Medical Oncology
Southampton, United Kingdom, SO16 6YD
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, United Kingdom, SM2 5PT
Singleton Hospital; Pharmacy Department
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02420821     History of Changes
Other Study ID Numbers: WO29637
2014-004684-20 ( EudraCT Number )
Study First Received: April 15, 2015
Last Updated: May 5, 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
Sunitinib
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on June 23, 2017