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

July 14, 2023 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

778

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico; Oncologia
      • Caba, Argentina, C1118AAT
        • Hospital Aleman
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (CORI)
  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle; Medical Oncology
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane & Women's Hosp; Cancer Care Serv
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Center Research
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital; Medical Oncology
  • Austria
      • Linz, Austria, 4020
        • Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome
  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 81520-060
        • Hospital Erasto Gaertner
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital das Clinicas - UFRGS
    • SP
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • Sao Paulo, SP, Brazil, 01323-903
        • Hospital Alemao Oswaldo Cruz
  • Canada
      • Quebec, Canada, G1R 3S1
        • Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre-Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre; Oncology
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre; Oncology
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Cancer Center
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Odette Cancer Centre
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital; Inpatient Pharmacy
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre - Glen Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
  • Chile
      • Recoleta, Chile, 8420383
        • Bradford Hill Centro de Investigaciones Clinicas
      • Temuco, Chile, 4800827
        • Sociedad de Investigaciones Medicas Ltda (SIM)
      • Vina Del Mar, Chile, 2520598
        • ONCOCENTRO APYS; Oncología
  • China
      • Nanjing City, China, 211100
        • Jiangsu Cancer Hospital
      • Shanghai City, China, 201315
        • Fudan University Shanghai Cancer Center; Medical Oncology
  • Czechia
      • Brno, Czechia, 656 53
        • Masarykuv onkologicky ustav
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc; Onkologicka klinika
      • Praha 2, Czechia, 128 08
        • General University Hospital; CLINIC OF ONCOLOGY
      • Praha 4 - Krc, Czechia, 140 59
        • Thomayerova nemocnice
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital; Kræftafdelingen
      • Herlev, Denmark, 2730
        • Herlev Hospital; Afdeling for Kræftbehandling
  • France
      • Angers, France, 49033
        • CHU d'Angers
      • Creteil, France, 94010
        • CHU Henri Mondor; Service d'Oncologie Medicale
      • Nantes, France, 44093
        • CHU de Nantes - Hôtel Dieu
      • Paris, France, 75674
        • Institut Mutualiste Montsouris; Oncologie
      • Rennes, France, 35000
        • CHU Pontchaillou
      • Rouen, France, 76031
        • CHU de Rouen - Hôpital Charles Nicolle
      • Strasbourg, France, 67091
        • Nouvel Hopital Civil - CHU Strasbourg; Urologie
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
      • Heidelberg, Germany, 69120
        • Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
      • Homburg/Saar, Germany, 66424
        • Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen; Klinik für Urologie
  • Ireland
      • Cork, Ireland
        • Cork Uni Hospital; Oncology Dept
      • Dublin, Ireland, 24
        • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
  • Israel
      • Beer Sheva, Israel, 8410100
        • Soroka Medical Center; Oncology Dept
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus; Oncology
      • Jerusalem, Israel, 9112000
        • Hadassah Ein Karem Hospital; Oncology Dept
      • Kfar-Saba, Israel, 4428164
        • Meir Medical Center; Oncology
      • Petach Tikva, Israel, 4941492
        • Belinson Medical Center, Division of Oncology
      • Ramat Gan, Israel, 5262000
        • Chaim Sheba medical center, Oncology division
      • Tel-Aviv, Israel, 6423900
        • Sourasky Medical Center; Oncology Department
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
      • Modena, Emilia-Romagna, Italy, 41100
        • A.O. Universitaria Policlinico Di Modena; Oncologia
    • Lombardia
      • Milano, Lombardia, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
      • Pavia, Lombardia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo, Oncologia
    • Toscana
      • Arezzo, Toscana, Italy, 52100
        • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
    • Veneto
      • Padova, Veneto, Italy, 35128
        • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
  • Japan
      • Aichi, Japan, 466-8560
        • Nagoya University Hospital
      • Aomori, Japan, 036-8563
        • Hirosaki University Hospital
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hyogo, Japan, 650-0017
        • Kobe University Hospital
      • Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital
      • Mie, Japan, 514-8507
        • Mie University Hospital
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of Jfcr
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital
      • Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital
      • Tokyo, Japan, 123-8558
        • Tokyo Women?s Medical University Adachi Medical Center
  • Korea, Republic of
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
      • Amsterdam, Netherlands, 1007 MB
        • VU Medisch Centrum; VU University Medical Center
      • Nijmegen, Netherlands, 6500 HB
        • UMC Radboud Nijmegen
      • Rotterdam, Netherlands, 3045 PM
        • Sint Franciscus Gasthuis; Inwendige Geneeskunde
      • Utrecht, Netherlands, 3543 AZ
        • St. Antonius locatie Leidsche Rijn
  • Poland
      • Kraków, Poland, 30-688
        • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
      • Kraków, Poland, 31-115
        • Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli
      • Pozna?, Poland, 60-569
        • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
      • Warszawa, Poland, 04-073
        • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Russian Federation
    • Altaj
      • Barnaul, Altaj, Russian Federation, 656049
        • Altai Region Oncology Dispensory; Oncology
    • Moskovskaja Oblast
      • Moscow, Moskovskaja Oblast, Russian Federation, 143423
        • City Clinical Oncology Hospital
      • Moscow, Moskovskaja Oblast, Russian Federation, 125248
        • P.A. Herzen Oncological Inst. ; Oncology
    • Niznij Novgorod
      • Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603001
        • Privolzhsk Regional Medical Center
    • Sankt Petersburg
      • Saint-Petersburg, Sankt Petersburg, Russian Federation, 197022
        • City Clinical Oncology Dispensary
    • Sverdlovsk
      • Yekaterinburg, Sverdlovsk, Russian Federation, 620102
        • Sverdlovsk Regional Clinical Hospital 1
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
      • Belgrade, Serbia, 11000
        • Clinic for Urology; Military Medical Academy
      • Sremska Kamenica, Serbia, 21204
        • Oncology Institute of Vojvodina
  • Spain
      • Barcelona, Spain, 08908
        • Institut Catala d Oncologia Hospital Duran i Reynals
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial; Servicio de Oncología
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal; Servicio de Oncologia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Oncologia
      • Madrid, Spain, 28040
        • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Univ. Central de Asturias; Servicio de Oncologia
    • Barcelona
      • Sant Andreu de La Barca, Barcelona, Spain, 08740
        • Hospital Univ Vall d'Hebron; Servicio de Oncologia
    • Cordoba
      • Córdoba, Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia; Servicio de Oncologia
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital; Urology
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital; Division of Urology
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital, Department of Urology
      • Taipei, Taiwan, 11217
        • TAIPEI VETERANS GENERAL HOSPITAL, Urology
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou, Urinary Oncology
  • Thailand
      • Bangkok, Thailand, 10330
        • Division of Urological surgery; Department of surgery, Chulalongkorn University
      • Chiangmai, Thailand, 50200
        • Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
  • Turkey
      • Adana, Turkey, 01230
        • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
      • Ankara, Turkey, 06590
        • Ankara Uni School of Medicine; Medical Oncology
      • Ankara, Turkey, 06500
        • Gazi University Medical Faculty; Department of ?nternal Medicine
      • Edirne, Turkey, 22030
        • Trakya University Medical Faculty
      • Sihhiye/Ankara, Turkey, 06230
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
      • Lviv, Ukraine, 79034
        • Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction
      • Sumy, Ukraine, 40005
        • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
      • Zaporizhzhia, Ukraine, 69600
        • Zaporizhzhia Regional Clinic
    • Kharkiv Governorate
      • Kharkiv, Kharkiv Governorate, Ukraine, 61037
        • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, NW3 2QS
        • Royal Free Hospital
      • Manchester, United Kingdom, M20 3BG
        • Christie Hospital
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital; Pharmacy Department
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic- Scottsdale
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Lancaster, California, United States, 93534
        • City of Hope, Antelope Valley
      • Los Angeles, California, United States
        • UCLA Urology; Urology
      • Orange, California, United States, 92868
        • University of California Irvine Medical Center
      • South Pasadena, California, United States, 91030
        • City of Hope-South Pasadena
      • Upland, California, United States, 91786
        • City of Hope; Upland
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Florida Cancer Specialists-Broadway, Fort Myers
      • Gainesville, Florida, United States, 32607
        • University of Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami, School of Med; Hem/Onc
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Uni - Winship Cancer Center; Hematology/Oncology
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
      • Maywood, Illinois, United States, 60151
        • Loyola University Medical Center, Cardinal Bernardin Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70112
        • Tulane Uni Health Sciences Center
    • Maryland
      • Towson, Maryland, United States, 21204
        • Chesapeake Urology Research Associates
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • New Jersey
      • Whippany, New Jersey, United States
        • Garden State Urology
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology at Albany Medical Center
      • New York, New York, United States, 10016
        • Bellevue Hospital
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10016
        • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center; Urology
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Fairview Hospital; Cleveland Clinic Cancer Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation; Hematology and Oncology
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital; Hirsch Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma; Stephenson Oklahoma Canc Ctr
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science Uni
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center; Hematology/Oncology
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Cnt Onco Clinic
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health Systems
      • Kingsport, Tennessee, United States, 37660
        • Urology Associates of Kingsport, P.C.
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center; Vanderbilt University
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030-4095
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah; Huntsman Cancer Hospital
    • West Virginia
      • Morgantown, West Virginia, United States, 26056
        • West Virginia University Hospitals Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator-assessed Disease-Free Survival (DFS)
Time Frame: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)
Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.
From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
Percentage of Participants With Anti-Drug Antibodies (ADA) 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)
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)
Overall Survival (OS)
Time Frame: From baseline up to death due to any cause (up to approximately 64 months)
OS was defined as the time from randomization to death from any cause.
From baseline up to death due to any cause (up to approximately 64 months)
Investigator-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 64 months)
Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.
From baseline until first occurrence of DFS event (up to approximately 64 months)
Independent Review Facility (IRF)-Assessed DFS
Time Frame: From baseline until first documented recurrence event (up to approximately 64 months)
IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.
From baseline until first documented recurrence event (up to approximately 64 months)
IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
Time Frame: From baseline until first occurrence of DFS event (up to approximately 64 months)
IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.
From baseline until first occurrence of DFS event (up to approximately 64 months)
IRF-assessed Event-free Survival (EFS)
Time Frame: From baseline until first documented recurrence event (up to approximately 64 months)
IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.
From baseline until first documented recurrence event (up to approximately 64 months)
Disease-Specific Survival
Time Frame: From baseline up to death due to RCC (up to approximately 64 months)
Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).
From baseline up to death due to RCC (up to approximately 64 months)
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 64 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 occurred first.
From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)
Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3
Time Frame: Up to 3 years
IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.
Up to 3 years
Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3
Time Frame: Up to 3 years
Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.
Up to 3 years
Percentage of Participants With Adverse Events
Time Frame: From baseline up to death due to any cause (up to approximately 71 months)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.
From baseline up to death due to any cause (up to approximately 71 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2017

Primary Completion (Actual)

May 3, 2022

Study Completion (Actual)

December 8, 2022

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimated)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO39210
  • 2016-001881-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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