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

NCT03024996 | Terminated Phase 3 Results DMC

• 2 other identifiers: WO392102016-001881-27
• Study Type: interventional
• Target: 778
• Locations: 27 countries
• Sites: 183

Brief Summary

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

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (13)

• Overall Survival (OS)

  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

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

• Independent Review Facility (IRF)-Assessed DFS

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

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

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

• IRF-assessed Event-free Survival (EFS)

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

Study Arms (2)

Atezolizumab

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Atezolizumab DRUG

Atezolizumab 1200 mg IV infusion q3w

Atezolizumab

Placebo OTHER

Placebo matching to atezolizumab q3w

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (186)

Mayo Clinic- Scottsdale

Scottsdale, Arizona, 85259, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

City of Hope, Antelope Valley

Lancaster, California, 93534, United States

Location

UCLA Urology; Urology

Los Angeles, California, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

City of Hope-South Pasadena

South Pasadena, California, 91030, United States

Location

City of Hope; Upland

Upland, California, 91786, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Florida Cancer Specialists-Broadway, Fort Myers

Fort Myers, Florida, 33908, United States

Location

University of Florida

Gainesville, Florida, 32607, United States

Location

Univ of Miami, School of Med; Hem/Onc

Miami, Florida, 33136, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory Uni - Winship Cancer Center; Hematology/Oncology

Atlanta, Georgia, 30322, United States

Location

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

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center, Cardinal Bernardin Cancer Center

Maywood, Illinois, 60151, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Tulane Uni Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Garden State Urology

Whippany, New Jersey, United States

Location

New York Oncology Hematology at Albany Medical Center

Albany, New York, 12208, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

New York, New York, 10016, United States

Location

Mount SInai Medical Center

New York, New York, 10029, United States

Location

University of Rochester Medical Center; Urology

Rochester, New York, 14642, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Fairview Hospital; Cleveland Clinic Cancer Center

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation; Hematology and Oncology

Cleveland, Ohio, 44195, United States

Location

Hillcrest Hospital; Hirsch Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

University of Oklahoma; Stephenson Oklahoma Canc Ctr

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health & Science Uni

Portland, Oregon, 97239, United States

Location

Fox Chase Cancer Center; Hematology/Oncology

Philadelphia, Pennsylvania, 19111, United States

Location

Sanford Cancer Cnt Onco Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Erlanger Health Systems

Chattanooga, Tennessee, 37403, United States

Location

Urology Associates of Kingsport, P.C.

Kingsport, Tennessee, 37660, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center; Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-4095, United States

Location

University of Utah; Huntsman Cancer Hospital

Salt Lake City, Utah, 84112, United States

Location

West Virginia University Hospitals Inc

Morgantown, West Virginia, 26056, United States

Location

Hospital Britanico; Oncologia

Buenos Aires, C1280AEB, Argentina

Location

Hospital Aleman

Caba, C1118AAT, Argentina

Location

Centro Oncologico Riojano Integral (CORI)

La Rioja, F5300COE, Argentina

Location

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, 2298, Australia

Location

Royal Brisbane & Women's Hosp; Cancer Care Serv

Herston, Queensland, 4029, Australia

Location

Ashford Cancer Center Research

Kurralta Park, South Australia, 5037, Australia

Location

Austin Hospital; Medical Oncology

Heidelberg, Victoria, 3084, Australia

Location

Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

Linz, 4020, Austria

Location

Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

Salzburg, 5020, Austria

Location

Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome

Vienna, 1090, Austria

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, 01323-903, Brazil

Location

Tom Baker Cancer Centre-Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Queen Elizabeth II Health Sciences Centre; Oncology

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario, K1H 8L6, Canada

Location

North York General Hospital; Inpatient Pharmacy

Toronto, Ontario, M2K 1E1, Canada

Location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 1Z5, Canada

Location

McGill University Health Centre - Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec

Québec, G1R 3S1, Canada

Location

Bradford Hill Centro de Investigaciones Clinicas

Recoleta, 8420383, Chile

Location

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, 4800827, Chile

Location

ONCOCENTRO APYS; Oncología

Viña del Mar, 2520598, Chile

Location

Jiangsu Cancer Hospital

Nanjing, 211100, China

Location

Fudan University Shanghai Cancer Center; Medical Oncology

Shanghai, 201315, China

Location

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Location

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, 779 00, Czechia

Location

General University Hospital; CLINIC OF ONCOLOGY

Prague, 128 08, Czechia

Location

Thomayerova nemocnice

Praha 4 - Krc, 140 59, Czechia

Location

Aarhus Universitetshospital; Kræftafdelingen

Aarhus N, 8200, Denmark

Location

Herlev Hospital; Afdeling for Kræftbehandling

Herlev, 2730, Denmark

Location

CHU d'Angers

Angers, 49033, France

Location

CHU Henri Mondor; Service d'Oncologie Medicale

Créteil, 94010, France

Location

CHU de Nantes - Hotel Dieu

Nantes, 44093, France

Location

Institut Mutualiste Montsouris; Oncologie

Paris, 75674, France

Location

CHU Pontchaillou

Rennes, 35000, France

Location

CHU de Rouen - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Nouvel Hopital Civil - CHU Strasbourg; Urologie

Strasbourg, 67091, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

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

Dresden, 01307, Germany

Location

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

Hanover, 30625, Germany

Location

Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

Heidelberg, 69120, Germany

Location

Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

Homburg/Saar, 66424, Germany

Location

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

München, 81675, Germany

Location

Universitätsklinikum Tübingen; Klinik für Urologie

Tübingen, 72076, Germany

Location

Cork Uni Hospital; Oncology Dept

Cork, Ireland

Location

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

Dublin, 24, Ireland

Location

Soroka Medical Center; Oncology Dept

Beersheba, 8410100, Israel

Location

Rambam Health Care Campus; Oncology

Haifa, 3109601, Israel

Location

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, 9112000, Israel

Location

Meir Medical Center; Oncology

Kfar Saba, 4428164, Israel

Location

Belinson Medical Center, Division of Oncology

Petah Tikva, 4941492, Israel

Location

Chaim Sheba medical center, Oncology division

Ramat Gan, 5262000, Israel

Location

Sourasky Medical Center; Oncology Department

Tel Aviv, 6423900, Israel

Location

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

Bologna, Emilia-Romagna, 40138, Italy

Location

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

Meldola, Emilia-Romagna, 47014, Italy

Location

A.O. Universitaria Policlinico Di Modena; Oncologia

Modena, Emilia-Romagna, 41100, Italy

Location

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

Milan, Lombardy, 20133, Italy

Location

Fondazione IRCCS Policlinico San Matteo, Oncologia

Pavia, Lombardy, 27100, Italy

Location

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

Arezzo, Tuscany, 52100, Italy

Location

IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

Padua, Veneto, 35128, Italy

Location

Nagoya University Hospital

Aichi, 466-8560, Japan

Location

Hirosaki University Hospital

Aomori, 036-8563, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Kobe University Hospital

Hyōgo, 650-0017, Japan

Location

University of Tsukuba Hospital

Ibaraki, 305-8576, Japan

Location

Mie University Hospital

Mie, 514-8507, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Jichi Medical University Hospital

Tochigi, 329-0498, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Toranomon Hospital

Tokyo, 105-8470, Japan

Location

Tokyo Medical and Dental University Hospital

Tokyo, 113-8519, Japan

Location

Nippon Medical School Hospital

Tokyo, 113-8603, Japan

Location

Tokyo Women?s Medical University Adachi Medical Center

Tokyo, 123-8558, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

VU Medisch Centrum; VU University Medical Center

Amsterdam, 1007 MB, Netherlands

Location

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

Location

UMC Radboud Nijmegen

Nijmegen, 6500 HB, Netherlands

Location

Sint Franciscus Gasthuis; Inwendige Geneeskunde

Rotterdam, 3045 PM, Netherlands

Location

St. Antonius locatie Leidsche Rijn

Utrecht, 3543 AZ, Netherlands

Location

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

Krakow, 30-688, Poland

Location

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

Krakow, 31-115, Poland

Location

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

Lublin, 20-090, Poland

Location

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

Późna, 60-569, Poland

Location

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

Warsaw, 04-073, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, 50-556, Poland

Location

Altai Region Oncology Dispensory; Oncology

Barnaul, Altayskiy Kray, 656049, Russia

Location

P.A. Herzen Oncological Inst. ; Oncology

Moscow, Moscow Oblast, 125248, Russia

Location

City Clinical Oncology Hospital

Moscow, Moscow Oblast, 143423, Russia

Location

Privolzhsk Regional Medical Center

Nizhny Novgorod, Niznij Novgorod, 603001, Russia

Location

City Clinical Oncology Dispensary

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

Sverdlovsk Regional Clinical Hospital 1

Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

Location

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

Belgrade, 11000, Serbia

Location

Clinic for Urology; Military Medical Academy

Belgrade, 11000, Serbia

Location

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Sant Andreu de la Barca, Barcelona, 08740, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, 14004, Spain

Location

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

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Hospital Univ. Central de Asturias; Servicio de Oncologia

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Clínic i Provincial; Servicio de Oncología

Barcelona, 08036, Spain

Location

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28007, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Location

China Medical University Hospital; Urology

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital; Division of Urology

Taichung, 407, Taiwan

Location

National Taiwan University Hospital, Department of Urology

Taipei, 10048, Taiwan

Location

TAIPEI VETERANS GENERAL HOSPITAL, Urology

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation-Linkou, Urinary Oncology

Taoyuan District, 333, Taiwan

Location

Division of Urological surgery; Department of surgery, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

Chiang Mai, 50200, Thailand

Location

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

Adana, 01230, Turkey (Türkiye)

Location

Gazi University Medical Faculty; Department of ?nternal Medicine

Ankara, 06500, Turkey (Türkiye)

Location

Ankara Uni School of Medicine; Medical Oncology

Ankara, 06590, Turkey (Türkiye)

Location

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, 06230, Turkey (Türkiye)

Location

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

Kharkiv, Kharkiv Governorate, 61037, Ukraine

Location

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

Dnipropetrovsk, 49102, Ukraine

Location

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

Lviv, 79034, Ukraine

Location

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

Sumy, 40005, Ukraine

Location

Zaporizhzhia Regional Clinic

Zaporizhzhia, 69600, Ukraine

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Royal Free Hospital

London, NW3 2QS, United Kingdom

Location

Christie Hospital

Manchester, M20 3BG, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Singleton Hospital; Pharmacy Department

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 36099926 DERIVED

• 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.

  PMID: 33526329 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: January 3, 2017
• Primary Completion: May 3, 2022
• Study Completion: December 8, 2022
• Last Updated: August 3, 2023
• Results First Posted: August 3, 2023

Record last verified: 2023-07

Locations

US (45); AR (3); AU (4); CN (2); IL (7); BE (2); BR (5); SE (3); KR (3); ES (10); RU (6); DK (2); JP (16); TW (5); TH (2); UA (5); GB (6); CL (3); CZ (4); FR (8); DE (6); PL (6); TU (5); CA (11); IE (2); IT (7); NL (5)