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

Primary Purpose

Renal Cell Carcinoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic- Scottsdale
  • City of Hope National Medical Center
  • City of Hope, Antelope Valley
  • UCLA Urology; Urology
  • University of California Irvine Medical Center
  • City of Hope-South Pasadena
  • City of Hope; Upland
  • University of Colorado Cancer Center
  • Yale School of Medicine
  • Florida Cancer Specialists-Broadway, Fort Myers
  • University of Florida
  • Univ of Miami, School of Med; Hem/Onc
  • Moffitt Cancer Center
  • Emory Uni - Winship Cancer Center; Hematology/Oncology
  • The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
  • Loyola University Medical Center, Cardinal Bernardin Cancer Center
  • Norton Cancer Institute
  • Tulane Uni Health Sciences Center
  • Ochsner Clinic Foundation
  • Chesapeake Urology Research Associates
  • Mayo Clinic - Rochester
  • Garden State Urology
  • New York Oncology Hematology at Albany Medical Center
  • Bellevue Hospital
  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
  • Mount SInai Medical Center
  • University of Rochester Medical Center; Urology
  • SUNY Upstate Medical University
  • University of North Carolina at Chapel Hill
  • Levine Cancer Institute
  • Fairview Hospital; Cleveland Clinic Cancer Center
  • Cleveland Clinic Foundation; Hematology and Oncology
  • Hillcrest Hospital; Hirsch Cancer Center
  • University of Oklahoma; Stephenson Oklahoma Canc Ctr
  • Oregon Health & Science Uni
  • Fox Chase Cancer Center; Hematology/Oncology
  • Sanford Cancer Cnt Onco Clinic
  • Erlanger Health Systems
  • Urology Associates of Kingsport, P.C.
  • Sarah Cannon Research Institute
  • Vanderbilt University Medical Center; Vanderbilt University
  • University of Texas Southwestern Medical Center
  • MD Anderson Cancer Center
  • University of Utah; Huntsman Cancer Hospital
  • West Virginia University Hospitals Inc
  • Hospital Britanico; Oncologia
  • Hospital Aleman
  • Centro Oncologico Riojano Integral (CORI)
  • Calvary Mater Newcastle; Medical Oncology
  • Royal Brisbane & Women's Hosp; Cancer Care Serv
  • Ashford Cancer Center Research
  • Austin Hospital; Medical Oncology
  • Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
  • Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
  • Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome
  • Cliniques Universitaires St-Luc
  • UZ Leuven Gasthuisberg
  • Hospital Erasto Gaertner
  • Hospital das Clinicas - UFRGS
  • Hospital Sao Lucas - PUCRS
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Hospital Alemao Oswaldo Cruz
  • Tom Baker Cancer Centre-Calgary
  • Cross Cancer Institute
  • BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
  • Queen Elizabeth II Health Sciences Centre; Oncology
  • The Ottawa Hospital Cancer Centre; Oncology
  • North York General Hospital; Inpatient Pharmacy
  • Sunnybrook Odette Cancer Centre
  • Princess Margaret Cancer Center
  • McGill University Health Centre - Glen Site
  • Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
  • Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
  • Bradford Hill Centro de Investigaciones Clinicas
  • Sociedad de Investigaciones Medicas Ltda (SIM)
  • ONCOCENTRO APYS; Oncología
  • Jiangsu Cancer Hospital
  • Fudan University Shanghai Cancer Center; Medical Oncology
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • General University Hospital; CLINIC OF ONCOLOGY
  • Thomayerova nemocnice
  • Aarhus Universitetshospital; Kræftafdelingen
  • Herlev Hospital; Afdeling for Kræftbehandling
  • CHU d'Angers
  • CHU Henri Mondor; Service d'Oncologie Medicale
  • CHU de Nantes - Hotel Dieu
  • Institut Mutualiste Montsouris; Oncologie
  • CHU Pontchaillou
  • CHU de Rouen - Hôpital Charles Nicolle
  • Nouvel Hopital Civil - CHU Strasbourg; Urologie
  • Institut Gustave Roussy
  • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
  • Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
  • Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
  • Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
  • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
  • Universitätsklinikum Tübingen; Klinik für Urologie
  • Cork Uni Hospital; Oncology Dept
  • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
  • Soroka Medical Center; Oncology Dept
  • Rambam Health Care Campus; Oncology
  • Hadassah Ein Karem Hospital; Oncology Dept
  • Meir Medical Center; Oncology
  • Belinson Medical Center, Division of Oncology
  • Chaim Sheba medical center, Oncology division
  • Sourasky Medical Center; Oncology Department
  • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • A.O. Universitaria Policlinico Di Modena; Oncologia
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Fondazione IRCCS Policlinico San Matteo, Oncologia
  • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
  • Nagoya University Hospital
  • Hirosaki University Hospital
  • Kyushu University Hospital
  • Kobe University Hospital
  • University of Tsukuba Hospital
  • Mie University Hospital
  • Niigata University Medical & Dental Hospital
  • Okayama University Hospital
  • Jichi Medical University Hospital
  • Tokushima University Hospital
  • Toranomon Hospital
  • Tokyo Medical and Dental University Hospital
  • Nippon Medical School Hospital
  • Tokyo Women?s Medical University Adachi Medical Center
  • The Cancer Institute Hospital of JFCR
  • Keio University Hospital
  • National Cancer Center
  • Asan Medical Center
  • Samsung Medical Center
  • VU Medisch Centrum; VU University Medical Center
  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
  • UMC Radboud Nijmegen
  • Sint Franciscus Gasthuis; Inwendige Geneeskunde
  • St. Antonius locatie Leidsche Rijn
  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
  • Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej
  • Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli
  • Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
  • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Altai Region Oncology Dispensory; Oncology
  • P.A. Herzen Oncological Inst. ; Oncology
  • City Clinical Oncology Hospital
  • Privolzhsk Regional Medical Center
  • City Clinical Oncology Dispensary
  • Sverdlovsk Regional Clinical Hospital 1
  • Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
  • Clinic for Urology; Military Medical Academy
  • Oncology Institute of Vojvodina
  • Hospital Univ. Central de Asturias; Servicio de Oncologia
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
  • Hospital Clínic i Provincial; Servicio de Oncología
  • Institut Catala d Oncologia Hospital Duran i Reynals
  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • China Medical University Hospital; Urology
  • Taichung Veterans General Hospital; Division of Urology
  • National Taiwan University Hospital, Department of Urology
  • TAIPEI VETERANS GENERAL HOSPITAL, Urology
  • Chang Gung Medical Foundation-Linkou, Urinary Oncology
  • Division of Urological surgery; Department of surgery, Chulalongkorn University
  • Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Gazi University Medical Faculty; Department of ?nternal Medicine
  • Ankara Uni School of Medicine; Medical Oncology
  • Trakya University Medical Faculty
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
  • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
  • Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction
  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
  • Zaporizhzhia Regional Clinic
  • Leicester Royal Infirmary
  • Royal Free Hospital
  • Christie Hospital
  • Freeman Hospital
  • Weston Park Hospital
  • Singleton Hospital; Pharmacy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atezolizumab

Placebo

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
OS was defined as the time from randomization to death from any cause.
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.
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.
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.
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.
Disease-Specific Survival
Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).
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.
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.
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.
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.
Maximum Serum Concentration (Cmax) of Atezolizumab
Minimum Serum Concentration (Cmin) of Atezolizumab
Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab

Full Information

First Posted
January 17, 2017
Last Updated
July 14, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03024996
Brief Title
A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy
Acronym
IMmotion010
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The sponsor decided to terminate this study before the protocol-defined end-of-study, as permitted per protocol.
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
778 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
Atezolizumab 1200 mg IV infusion q3w
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to atezolizumab q3w
Primary Outcome Measure Information:
Title
Investigator-assessed Disease-Free Survival (DFS)
Description
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.
Time Frame
From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to death from any cause.
Time Frame
From baseline up to death due to any cause (up to approximately 64 months)
Title
Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3
Description
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.
Time Frame
From baseline until first occurrence of DFS event (up to approximately 64 months)
Title
Independent Review Facility (IRF)-Assessed DFS
Description
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.
Time Frame
From baseline until first documented recurrence event (up to approximately 64 months)
Title
IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
Description
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.
Time Frame
From baseline until first occurrence of DFS event (up to approximately 64 months)
Title
IRF-assessed Event-free Survival (EFS)
Description
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.
Time Frame
From baseline until first documented recurrence event (up to approximately 64 months)
Title
Disease-Specific Survival
Description
Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).
Time Frame
From baseline up to death due to RCC (up to approximately 64 months)
Title
Distant Metastasis-Free Survival
Description
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.
Time Frame
From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)
Title
Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3
Description
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.
Time Frame
Up to 3 years
Title
Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3
Description
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.
Time Frame
Up to 3 years
Title
Percentage of Participants With Adverse Events
Description
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.
Time Frame
From baseline up to death due to any cause (up to approximately 71 months)
Title
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)
Title
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)
Title
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)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
36099926
Citation
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.
Results Reference
derived
PubMed Identifier
33526329
Citation
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.
Results Reference
derived

Learn more about this trial

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

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