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AzTrials

Renal Cell CarcinomaPhase 3IMmotion010NCT03024996

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

A Phase 3 study testing Atezolizumab in people with Renal Cell Carcinoma, run by Hoffmann-La Roche at 186 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
778 participants
Where
186 sitesin 28 countries
Study dates
3 Jan 2017to 8 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

186 sites in 28 countries.

186 sites in 28 countries

United States45 sites

  • New York Oncology Hematology at Albany Medical Center

    Albany, New York, 12208

  • Emory Uni - Winship Cancer Center; Hematology/Oncology

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Erlanger Health Systems

    Chattanooga, Tennessee, 37403

  • The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology

    Chicago, Illinois, 60637

  • Fairview Hospital; Cleveland Clinic Cancer Center

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation; Hematology and Oncology

    Cleveland, Ohio, 44195

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Florida Cancer Specialists-Broadway, Fort Myers

    Fort Myers, Florida, 33908

  • University of Florida

    Gainesville, Florida, 32607

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4095

  • Urology Associates of Kingsport, P.C.

    Kingsport, Tennessee, 37660

  • City of Hope, Antelope Valley

    Lancaster, California, 93534

  • UCLA Urology; Urology

    Los Angeles, California

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Hillcrest Hospital; Hirsch Cancer Center

    Mayfield Heights, Ohio, 44124

  • Loyola University Medical Center, Cardinal Bernardin Cancer Center

    Maywood, Illinois, 60151

  • Univ of Miami, School of Med; Hem/Onc

    Miami, Florida, 33136

  • West Virginia University Hospitals Inc

    Morgantown, West Virginia, 26056

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center; Vanderbilt University

    Nashville, Tennessee, 37232

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Tulane Uni Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Bellevue Hospital

    New York, New York, 10016

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    New York, New York, 10016

  • Mount SInai Medical Center

    New York, New York, 10029

  • University of Oklahoma; Stephenson Oklahoma Canc Ctr

    Oklahoma City, Oklahoma, 73104

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Fox Chase Cancer Center; Hematology/Oncology

    Philadelphia, Pennsylvania, 19111

  • Oregon Health & Science Uni

    Portland, Oregon, 97239

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center; Urology

    Rochester, New York, 14642

  • University of Utah; Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • Mayo Clinic- Scottsdale

    Scottsdale, Arizona, 85259

  • Sanford Cancer Cnt Onco Clinic

    Sioux Falls, South Dakota, 57104

  • City of Hope-South Pasadena

    South Pasadena, California, 91030

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

  • City of Hope; Upland

    Upland, California, 91786

  • Garden State Urology

    Whippany, New Jersey

Other trials in United States

Japan16 sites

  • Nagoya University Hospital

    Aichi, 466-8560

  • Hirosaki University Hospital

    Aomori, 036-8563

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Kobe University Hospital

    Hyōgo, 650-0017

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • Mie University Hospital

    Mie, 514-8507

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Okayama University Hospital

    Okayama, 700-8558

  • Jichi Medical University Hospital

    Tochigi, 329-0498

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Toranomon Hospital

    Tokyo, 105-8470

  • Tokyo Medical and Dental University Hospital

    Tokyo, 113-8519

  • Nippon Medical School Hospital

    Tokyo, 113-8603

  • Tokyo Women?s Medical University Adachi Medical Center

    Tokyo, 123-8558

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Keio University Hospital

    Tokyo, 160-8582

Other trials in Japan

Canada11 sites

  • Tom Baker Cancer Centre-Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Queen Elizabeth II Health Sciences Centre; Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

    Kelowna, British Columbia, V1Y 5L3

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital Cancer Centre; Oncology

    Ottawa, Ontario, K1H 8L6

  • Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec

    Québec, G1R 3S1

  • Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • North York General Hospital; Inpatient Pharmacy

    Toronto, Ontario, M2K 1E1

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Spain10 sites

  • Hospital Clínic i Provincial; Servicio de Oncología

    Barcelona, 08036

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Univ. Central de Asturias; Servicio de Oncologia

    Oviedo, Principality of Asturias, 33011

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Sant Andreu de la Barca, Barcelona, 08740

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    Santiago de Compostela, LA Coruña, 15706

Other trials in Spain

France8 sites

  • CHU d'Angers

    Angers, 49033

  • CHU Henri Mondor; Service d'Oncologie Medicale

    Créteil, 94010

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093

  • Institut Mutualiste Montsouris; Oncologie

    Paris, 75674

  • CHU Pontchaillou

    Rennes, 35000

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, 76031

  • Nouvel Hopital Civil - CHU Strasbourg; Urologie

    Strasbourg, 67091

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Israel7 sites

  • Soroka Medical Center; Oncology Dept

    Beersheba, 8410100

  • Rambam Health Care Campus; Oncology

    Haifa, 3109601

  • Hadassah Ein Karem Hospital; Oncology Dept

    Jerusalem, 9112000

  • Meir Medical Center; Oncology

    Kfar Saba, 4428164

  • Belinson Medical Center, Division of Oncology

    Petah Tikva, 4941492

  • Chaim Sheba medical center, Oncology division

    Ramat Gan, 5262000

  • Sourasky Medical Center; Oncology Department

    Tel Aviv, 6423900

Other trials in Israel

Italy7 sites

  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

    Arezzo, Tuscany, 52100

  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

    Bologna, Emilia-Romagna, 40138

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

    Meldola, Emilia-Romagna, 47014

  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

    Milan, Lombardy, 20133

  • A.O. Universitaria Policlinico Di Modena; Oncologia

    Modena, Emilia-Romagna, 41100

  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

    Padova, Veneto, 35128

  • Fondazione IRCCS Policlinico San Matteo, Oncologia

    Pavia, Lombardy, 27100

Other trials in Italy

Germany6 sites

  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

    Dresden, 01307

  • Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

    Hanover, 30625

  • Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

    Homburg/Saar, 66424

  • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

    München, 81675

  • Universitätsklinikum Tübingen; Klinik für Urologie

    Tübingen, 72076

Other trials in Germany

Poland6 sites

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    Krakow, 30-688

  • Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej

    Krakow, 31-115

  • Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli

    Lublin, 20-090

  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

    Późna, 60-569

  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

    Warsaw, 04-073

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-556

Other trials in Poland

Russia6 sites

  • Altai Region Oncology Dispensory; Oncology

    Barnaul, Altayskiy Kray, 656049

  • P.A. Herzen Oncological Inst. ; Oncology

    Moscow, Moscow Oblast, 125248

  • City Clinical Oncology Hospital

    Moscow, Moscow Oblast, 143423

  • Privolzhsk Regional Medical Center

    Nizhny Novgorod, Niznij Novgorod, 603001

  • City Clinical Oncology Dispensary

    Saint Petersburg, Sankt-Peterburg, 197022

  • Sverdlovsk Regional Clinical Hospital 1

    Yekaterinburg, Sverdlovsk Oblast, 620102

Other trials in Russia

United Kingdom6 sites

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Royal Free Hospital

    London, NW3 2QS

  • Christie Hospital

    Manchester, M20 3BG

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Weston Park Hospital

    Sheffield, S10 2SJ

  • Singleton Hospital; Pharmacy Department

    Swansea, SA2 8QA

Other trials in United Kingdom

Brazil5 sites

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01323-903

Other trials in Brazil

Netherlands5 sites

  • VU Medisch Centrum; VU University Medical Center

    Amsterdam, 1007 MB

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

  • UMC Radboud Nijmegen

    Nijmegen, 6500 HB

  • Sint Franciscus Gasthuis; Inwendige Geneeskunde

    Rotterdam, 3045 PM

  • St. Antonius locatie Leidsche Rijn

    Utrecht, 3543 AZ

Other trials in Netherlands

Taiwan5 sites

  • China Medical University Hospital; Urology

    Taichung, 40447

  • Taichung Veterans General Hospital; Division of Urology

    Taichung, 407

  • National Taiwan University Hospital, Department of Urology

    Taipei, 10048

  • TAIPEI VETERANS GENERAL HOSPITAL, Urology

    Taipei, 11217

  • Chang Gung Medical Foundation-Linkou, Urinary Oncology

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

    Adana, 01230

  • Gazi University Medical Faculty; Department of ?nternal Medicine

    Ankara, 06500

  • Ankara Uni School of Medicine; Medical Oncology

    Ankara, 06590

  • Trakya University Medical Faculty

    Edirne, 22030

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sihhiye/Ankara, 06230

Other trials in Turkey (Türkiye)

Ukraine5 sites

  • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

    Dnipropetrovsk, 49102

  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

    Kharkiv, Kharkiv Governorate, 61037

  • Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction

    Lviv, 79034

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

    Sumy, 40005

  • Zaporizhzhia Regional Clinic

    Zaporizhzhya, 69600

Other trials in Ukraine

Australia4 sites

  • Austin Hospital; Medical Oncology

    Heidelberg, Victoria, 3084

  • Royal Brisbane & Women's Hosp; Cancer Care Serv

    Herston, Queensland, 4029

  • Ashford Cancer Center Research

    Kurralta Park, South Australia, 5037

  • Calvary Mater Newcastle; Medical Oncology

    Waratah, New South Wales, 2298

Other trials in Australia

Czechia4 sites

  • Masarykuv onkologicky ustav

    Brno, 656 53

  • Fakultni nemocnice Olomouc; Onkologicka klinika

    Olomouc, 779 00

  • General University Hospital; CLINIC OF ONCOLOGY

    Prague, 128 08

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59

Other trials in Czechia

Argentina3 sites

  • Hospital Britanico; Oncologia

    Buenos Aires, C1280AEB

  • Hospital Aleman

    Caba, C1118AAT

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

Other trials in Argentina

Austria3 sites

  • Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

    Linz, 4020

  • Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

    Salzburg, 5020

  • Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome

    Vienna, 1090

Other trials in Austria

Chile3 sites

  • Bradford Hill Centro de Investigaciones Clinicas

    Recoleta, 8420383

  • Sociedad de Investigaciones Medicas Ltda (SIM)

    Temuco, 4800827

  • ONCOCENTRO APYS; Oncología

    Viña del Mar, 2520598

Other trials in Chile

Serbia3 sites

  • Clinic for Urology, Clinical Center of Serbia; Clinic for Urology

    Belgrade, 11000

  • Clinic for Urology; Military Medical Academy

    Belgrade, 11000

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

Other trials in Serbia

South Korea3 sites

  • National Cancer Center

    Goyang-si, 10408

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

Belgium2 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

China2 sites

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • Fudan University Shanghai Cancer Center; Medical Oncology

    Shanghai, 201315

Other trials in China

Denmark2 sites

  • Aarhus Universitetshospital; Kræftafdelingen

    Aarhus N, 8200

  • Herlev Hospital; Afdeling for Kræftbehandling

    Herlev, 2730

Other trials in Denmark

Ireland2 sites

  • Cork Uni Hospital; Oncology Dept

    Cork

  • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

    Dublin, 24

Other trials in Ireland

Thailand2 sites

  • Division of Urological surgery; Department of surgery, Chulalongkorn University

    Bangkok, 10330

  • Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

    Chiang Mai, 50200

Other trials in Thailand

About this study

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

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.

Being tested
Atezolizumab, Placebo
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Atezolizumab 1200 mg IV infusion q3w

  • PlaceboOther

    Placebo matching to atezolizumab q3w

Study groups in NCT03024996
Study groupRoleWhat they receive
AtezolizumabExperimentalParticipants 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).
Receives: Drug: Atezolizumab
PlaceboPlacebo comparatorParticipants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-assessed Disease-Free Survival (DFS)

    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.

    Measured: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)

Secondary outcomes (13)

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause.

    Measured: From baseline up to death due to any cause (up to approximately 64 months)

  2. Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3

    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.

    Measured: From baseline until first occurrence of DFS event (up to approximately 64 months)

  3. Independent Review Facility (IRF)-Assessed DFS

    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.

    Measured: From baseline until first documented recurrence event (up to approximately 64 months)

  4. IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3

    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.

    Measured: From baseline until first occurrence of DFS event (up to approximately 64 months)

  5. IRF-assessed Event-free Survival (EFS)

    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.

    Measured: From baseline until first documented recurrence event (up to approximately 64 months)

  6. Disease-Specific Survival

    Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).

    Measured: From baseline up to death due to RCC (up to approximately 64 months)

  7. Distant Metastasis-Free Survival

    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.

    Measured: From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)

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

    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.

    Measured: Up to 3 years

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

    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.

    Measured: Up to 3 years

  10. Percentage of Participants With Adverse Events

    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.

    Measured: From baseline up to death due to any cause (up to approximately 71 months)

  11. Maximum Serum Concentration (Cmax) of Atezolizumab

    Measured: 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

    Measured: 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2017 (estimated)
  2. Study start3 Jan 2017
  3. Primary completion3 May 2022
  4. Study completion8 Dec 2022

Why it stopped: The sponsor decided to terminate this study before the protocol-defined end-of-study, as permitted per protocol.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
778 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03024996
Sponsor's protocol ID
WO39210
Other IDs
2016-001881-27, 2016
Acronym
IMmotion010
Status last verified
Jul 2023
First submitted
17 Jan 2017
Last updated
3 Aug 2023
Data monitoring committee
Yes

Publications

  • Pal SK, Uzzo R, Karam JA, Master VA, Donskov F, Suarez C, Albiges L, Rini B, Tomita Y, Kann AG, Procopio G, Massari F, Zibelman M, Antonyan I, Huseni M, Basu D, Ci B, Leung W, Khan O, Dubey S, Bex A. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022 Oct 1;400(10358):1103-1116. doi: 10.1016/S0140-6736(22)01658-0. Epub 2022 Sep 10.

    PubMed 36099926

  • Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

    PubMed 33526329

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab in people with Renal Cell Carcinoma, run by Hoffmann-La Roche at 186 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in United States, Japan, Canada, Spain, France and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-assessed Disease-Free Survival (DFS) (time frame: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03024996, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.

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