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A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC) (IMmotion151)

Primary Purpose

Renal Cell Carcinoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Bevacizumab

Sunitinib

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:

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

Exclusion Criteria:

Disease-Specific Exclusions:

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

General Medical Exclusions:

Life expectancy less than 12 weeks
Participation in another experimental drug study within 4 weeks prior to treatment
Pregnant or lactating women
Known hypersensitivity to any component of atezolizumab or other study medication
History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
Positive human immunodeficiency virus test
Active or chronic hepatitis B or C
Severe infections within 4 weeks prior to treatment
Exposure to oral or IV antibiotics within 2 weeks prior to treatment
Live attenuated vaccines within 4 weeks prior to treatment (for influenza vaccination participants must agree not to receive live, attenuated influenza vaccine within 4 weeks prior to treatment, during treatment or within 5 months following the last dose)
Significant cardiovascular disease
Prior allogeneic stem cell or solid organ transplantation

Exclusion Criteria Related to Medications:

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

Bevacizumab- and Sunitinib-Specific Exclusions:

History of hypertensive crisis or hypertensive encephalopathy
Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds

Sites / Locations

University of Arizona Cancer Center
University of California at Irvine Medical Center; Department of Oncology
University of California
University of Colorado; Anschutz Cancer Pavilion
Rocky Mountain Cancer Center; Medical Oncology
Georgetown U; Lombardi Comp Can
Lynn Cancer Institute/Boca Raton Regional Hospital
Florida Cancer Specialists - Port Charlotte
Florida Cancer Specialist, North Region
Piedmont Cancer Institute, PC
The University of Chicago
Norton Cancer Institute
Massachusetts General Hospital
Dana Farber Cancer Inst.
Beth Israel Deaconess Medical Center
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Hackensack University Medical Center
New York Oncology Hematology,P.C.-Albany
Memorial Sloan-Kettering Cancer Center
Oncology Hematology Care Inc
Cleveland Clinic Foundation; Taussig Cancer Center
Northwest Cancer Specialists, P.C.
SCRI Tennessee Oncology Chattanooga
Sarah Cannon Cancer Center and Research Institute
Vanderbilt Univ Medical Ctr
Texas Oncology-Baylor Sammons Cancer Center
Oncology and Hematology Associates of SW Virginia-Raonoke
Seattle Cancer Care Alliance
Lifehouse
Macquarie University Hospital
Calvary Mater Newcastle; Medical Oncology
Icon Cancer Foundation
Ashford Cancer Center Research
Austin Hospital; Medical Oncology
St John of God Hospital
University Clinical Centre of the Republic of Srpska
Hospital de Caridade de Ijui; Oncologia
Santa Casa de Misericordia de Porto Alegre
Hospital Sao Lucas - PUCRS
Instituto do Cancer do Estado de Sao Paulo - ICESP
Queen Elizabeth II Health Sciences Centre; Oncology
Royal Victoria Hospital
Hamilton Health Sciences - Juravinski Cancer Centre
London Regional Cancer Centre
Lakeridge Health Oshawa; Oncology
The Ottawa Hospital Cancer Centre; Oncology
Sunnybrook Odette Cancer Centre
Princess Margaret Cancer Center
Jewish General Hospital
CHU de Quebec Hotel-Dieu de Quebec
Masarykuv onkologicky ustav
Fakultni nemocnice Olomouc; Onkologicka klinika
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Thomayerova nemocnice
Aarhus Universitetshospital; Kræftafdelingen
Herlev Hospital; Afdeling for Kræftbehandling
Odense Universitetshospital, Onkologisk Afdeling R
ICO Paul Papin; Oncologie Medicale.
Hopital Saint Andre; Oncologie 2
Centre Francois Baclesse; Urologie Gynecologie
Centre Oscar Lambret
Centre Léon Bérard
Institut Paoli Calmettes; Oncologie Medicale
Centre D'Oncologie de Gentilly; Oncology
APHP - Hospital Saint Louis
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
ICO - Site René Gauducheau
Institut Gustave Roussy; Departement Oncologie Medicale
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
Klinikum d.Universität München Campus Großhadern
Universitätsklinikum Tübingen; Klinik für Urologie
Az. Osp. Cardarelli; Divisione Di Oncologia
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
A.O. Universitaria Policlinico Di Modena; Oncologia
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Irccs Ospedale San Raffaele;Oncologia Medica
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Fondazione IRCCS Policlinico San Matteo, Oncologia
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
Nagoya University Hospital; Urology
Chiba Cancer Center
Kyushu University Hospital
Gunma University Hospital
Hokkaido University Hospital
University of Tsukuba Hospital; Urology
Iwate Medical University Hospital
Yokohama City University Hospital
Kitasato University Hospital
Kumamoto University Hospital
Niigata University Medical & Dental Hospital
Okayama University Hospital
Osaka International Cancer Institute; Urology
Osaka Metropolitan University Hospital
Osaka University Hospital
Kindai University Hospital
Tokushima University Hospital
Toranomon Hospital
Tokyo Medical and Dental University Hospital
Nippon Medical School Hospital
The Cancer Institute Hospital, JFCR; Urology
Keio University Hospital
Tokyo Women's Medical University
Chungnam National University Hospital
National Cancer Center
Seoul National University Bundang Hospital
Severance Hospital, Yonsei University Health System
Seoul National University Hospital
Asan Medical Center
Samsung Medical Center
Cancerología
Centro Oncologico Estatal ISSEMYM
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
Saint Elizabeth's Hospital
MAGODENT Sp. z o.o.
ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
P.A. Herzen Oncological Inst. ; Oncology
City Clinical Oncology Hospital
National University Hospital
National Cancer Centre; Medical Oncology
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Hospital Universitario Reina Sofia; Servicio de Oncologia
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Hospital Clínic i Provincial; Servicio de Oncología
Hospital Duran i Reynals; Oncologia
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Hospital Ramon y Cajal; Servicio de Oncologia
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Taichung Veterans General Hospital; Division of Urology
National Taiwan Uni Hospital; Dept of Oncology
Chang Gung Medical Foundation-Linkou, Urinary Oncology
Chulalongkorn Hospital; Medical Oncology
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
Songklanagarind Hospital; Department of Oncology
Hacettepe University Medical Faculty
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Clatterbridge Cancer Centre
Queen Elizabeth Hospital
Royal Blackburn Hospital
Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
Barts Health NHS Trust - St Bartholomew's Hospital
Royal Free Hospital; Dept of Oncology
Christie Hospital Nhs Trust; Medical Oncology
Churchill Hospital; Oxford Cancer and Haematology Centre
Southampton General Hospital; Medical Oncology
Royal Marsden Hospital; Dept of Medical Oncology
Singleton Hospital; Pharmacy Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atezolizumab + Bevacizumab

Sunitinib

Arm Description

Participants will receive both atezolizumab and bevacizumab until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first.

Participants will receive sunitinib until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression, withdrawal of consent, or death, whichever occurs first.

Outcomes

Primary Outcome Measures

Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population

Tumor response was assessed by the investigator according to RECIST v1.1. Disease Progression (PD) was defined as greater than or equal to (>/=) 20 percent (%) relative increase in the sum of diameters (SoD) of all target lesions (TLs), taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 millimeters (mm); >/=1 new lesion(s); and/or unequivocal progression of existing non-TLs.

Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population

PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley.

Percentage of Participants Who Died of Any Cause in ITT Population

Percentage of participants who died of any cause was reported.

Overall Survival (OS) in ITT Population

OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.

Secondary Outcome Measures

Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population

Percentage of participants who died of any cause was reported.

OS in PD-L1-Selected Population

Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population

Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.

PFS as Determined by an IRC According to RECIST v1.1 in ITT Population

PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.

Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population

PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population

Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population

Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to less than (<) 10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.

Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population

DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.

Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population

Tumor response was assessed by an IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.

DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population

DOR was defined as the time from the first occurrence of CR/PR to PD as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.

Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population

Tumor response was assessed by the investigator according to immune-modified RECIST. PD was defined as >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm.

PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population

PFS was defined as the time from randomization to PD, as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.

Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population

Tumor response was assessed by the investigator according to immune-modified RECIST. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.

DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population

DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.

Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population

Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.

PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population

PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.

Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology

PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology

PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.

Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology

Percentage of participants with sarcomatoid histology who died of any cause was reported.

OS in Participants With Sarcomatoid Histology

Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score

The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part II, participants were asked to rate how much the symptoms have interfered with 6 areas of function (general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely) and total Part II score was calculated as an average of 6-item scores. Repeated measures model-estimated least-squares (LS) mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement. Here, 'Number Analyzed' = number of participants evaluable at specified time point.

Change From Baseline in Symptom Severity as Determined by MDASI Part I Score

The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part I, participants were asked to rate how severe the symptoms (pain, fatigue, nausea, disturbed sleep, feeling of being distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, feeling sad, vomiting, numbness or tingling, rash/skin changes, headache, mouth/throat sores, and diarrhea) were when "at their worst" in the last 24 hours. Each item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Mixed-effects model-estimated LS mean score for change from baseline at the end-of treatment is reported for each item, where a negative value indicates improvement.

Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score

The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI interference subscale (6 items) assessed the impact of fatigue on global domains (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely). Change from baseline in the mean score of all 6 items at each timepoint is reported, where a negative value indicates improvement.

Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item

The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI worst fatigue item assessed the severity of fatigue at its worst in the last 24 hours. The item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Change from baseline in the score at each time point is reported, where a negative value indicates improvement.

Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score

The FKSI-19 is a 19-item tool designed to assess the most important symptoms and concerns related to treatment effectiveness in advanced kidney cancer. The FKSI-19 GP5 item (bothered by the side effect of treatment) assessed side effects burden in the past 7 days on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Repeated measures model-estimated LS mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement.

Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab

The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against atezolizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint.

Number of Participants With ATAs Against Bevacizumab

The number of participants with "Treatment-induced ATAs" and "Treatment-enhanced ATA" against bevacizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.

Maximum Observed Serum Concentration (Cmax) for Atezolizumab

Cmax for atezolizumab was estimated from plasma concentration versus time data.

Minimum Observed Serum Concentration (Cmin) for Atezolizumab

Cmin for atezolizumab was estimated from plasma concentration versus time data.

Cmax for Bevacizumab

Cmax for bevacizumab was estimated from plasma concentration versus time data.

Cmin for Bevacizumab

Cmin for bevacizumab was estimated from plasma concentration versus time data.

Full Information

NCT ID

NCT02420821

First Posted

April 15, 2015

Last Updated

January 4, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02420821

Brief Title

A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)

Acronym

IMmotion151

Official Title

A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

May 20, 2015 (Actual)

Primary Completion Date

February 14, 2020 (Actual)

Study Completion Date

December 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.

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

None (Open Label)

Allocation

Randomized

Enrollment

915 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atezolizumab + Bevacizumab

Arm Type

Experimental

Arm Description

Arm Title

Sunitinib

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Other Intervention Name(s)

Tecentriq, MPDL3280A

Intervention Description

Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Days 1 and 22 of each 42-day cycle.

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab will be administered at a dose of 15 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 22 of each 42-day cycle.

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Other Intervention Name(s)

Sutent

Intervention Description

Sunitinib will be administered at a dose of 50 mg once daily, orally via capsule, on Day 1 through Day 28 of each 42-day cycle.

Primary Outcome Measure Information:

Title

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Percentage of Participants Who Died of Any Cause in ITT Population

Description

Percentage of participants who died of any cause was reported.

Time Frame

Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Title

Overall Survival (OS) in ITT Population

Description

Time Frame

Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population

Description

Percentage of participants who died of any cause was reported.

Time Frame

Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Title

OS in PD-L1-Selected Population

Description

Time Frame

Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Title

Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

PFS as Determined by an IRC According to RECIST v1.1 in ITT Population

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Description

Time Frame

Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population

Description

Time Frame

Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population

Description

Time Frame

Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population

Description

Time Frame

Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population

Description

Time Frame

Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population

Description

Time Frame

Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology

Description

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology

Description

PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.

Time Frame

Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)

Title

Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology

Description

Percentage of participants with sarcomatoid histology who died of any cause was reported.

Time Frame

Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Title

OS in Participants With Sarcomatoid Histology

Description

Time Frame

Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)

Title

Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score

Description

Time Frame

Baseline (Day 1 Cycle 1); Day 22 Cycle 1; Day 1 and 22 of every cycle from Cycle 2 up to Cycle 19; Cycle length = 42 days

Title

Change From Baseline in Symptom Severity as Determined by MDASI Part I Score

Description

The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part I, participants were asked to rate how severe the symptoms (pain, fatigue, nausea, disturbed sleep, feeling of being distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, feeling sad, vomiting, numbness or tingling, rash/skin changes, headache, mouth/throat sores, and diarrhea) were when "at their worst" in the last 24 hours. Each item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Mixed-effects model-estimated LS mean score for change from baseline at the end-of treatment is reported for each item, where a negative value indicates improvement.

Time Frame

Baseline; End of Treatment (EoT) visit (up to approximately 27 months)

Title

Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score

Description

Time Frame

Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days

Title

Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item

Description

Time Frame

Title

Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score

Description

Time Frame

Day 1 and 22 of every cycle (Baseline = Day 1 Cycle 1) up to Cycle 19; Cycle length = 42 days

Title

Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab

Description

Time Frame

Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycles 2, 4, and 8, and every eight cycles thereafter up to EoT [up to approximately 27 months] and 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)

Title

Number of Participants With ATAs Against Bevacizumab

Description

Time Frame

Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycle 3, at EoT [up to approximately 27 months] and at 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)

Title

Maximum Observed Serum Concentration (Cmax) for Atezolizumab

Description

Cmax for atezolizumab was estimated from plasma concentration versus time data.

Time Frame

30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)

Title

Minimum Observed Serum Concentration (Cmin) for Atezolizumab

Description

Cmin for atezolizumab was estimated from plasma concentration versus time data.

Time Frame

Predose (Hour 0) on Day 22 of Cycle 1; predose (Hour 0) on Day 1 of Cycles 2; Cycle length = 42 days

Title

Cmax for Bevacizumab

Description

Cmax for bevacizumab was estimated from plasma concentration versus time data.

Time Frame

30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)

Title

Cmin for Bevacizumab

Description

Cmin for bevacizumab was estimated from plasma concentration versus time data.

Time Frame

Pre-dose (Hour 0) on Day 1 of Cycle 3 (Cycle length = 42 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Definitive diagnosis of unresectable locally advanced or metastatic RCC with clear-cell histology and/or a component of sarcomatoid carcinoma, with no prior treatment in the metastatic setting Evaluable Memorial Sloan Kettering Cancer Center risk score Measurable disease, as defined by RECIST v1.1 Karnofsky performance status greater than or equal to 70% Adequate hematologic and end-organ function prior to randomization Exclusion Criteria: Disease-Specific Exclusions: Radiotherapy for RCC within 14 days prior to treatment Active central nervous system disease Uncontrolled pleural effusion, pericardial effusion, or ascites Uncontrolled hypercalcemia Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death General Medical Exclusions: Life expectancy less than 12 weeks Participation in another experimental drug study within 4 weeks prior to treatment Pregnant or lactating women Known hypersensitivity to any component of atezolizumab or other study medication History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis Positive human immunodeficiency virus test Active or chronic hepatitis B or C Severe infections within 4 weeks prior to treatment Exposure to oral or IV antibiotics within 2 weeks prior to treatment Live attenuated vaccines within 4 weeks prior to treatment (for influenza vaccination participants must agree not to receive live, attenuated influenza vaccine within 4 weeks prior to treatment, during treatment or within 5 months following the last dose) Significant cardiovascular disease Prior allogeneic stem cell or solid organ transplantation Exclusion Criteria Related to Medications: Prior treatment with cluster of differentiation 137 agonists, anti-cytotoxic T-lymphocyte associated protein-4, anti-programmed death (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents Treatment with immunostimulatory agents for non-malignant conditions within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment Bevacizumab- and Sunitinib-Specific Exclusions: History of hypertensive crisis or hypertensive encephalopathy Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds

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

University of Arizona Cancer Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Facility Name

University of California at Irvine Medical Center; Department of Oncology

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

University of California

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Facility Name

University of Colorado; Anschutz Cancer Pavilion

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Rocky Mountain Cancer Center; Medical Oncology

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80303

Country

United States

Facility Name

Georgetown U; Lombardi Comp Can

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016-1468

Country

United States

Facility Name

Lynn Cancer Institute/Boca Raton Regional Hospital

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Florida Cancer Specialists - Port Charlotte

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33980

Country

United States

Facility Name

Florida Cancer Specialist, North Region

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Piedmont Cancer Institute, PC

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

The University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Norton Cancer Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana Farber Cancer Inst.

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada - Eastern Avenue

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

New York Oncology Hematology,P.C.-Albany

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Oncology Hematology Care Inc

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Cleveland Clinic Foundation; Taussig Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Northwest Cancer Specialists, P.C.

City

Tigard

State/Province

Oregon

ZIP/Postal Code

97223

Country

United States

Facility Name

SCRI Tennessee Oncology Chattanooga

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Sarah Cannon Cancer Center and Research Institute

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Vanderbilt Univ Medical Ctr

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Texas Oncology-Baylor Sammons Cancer Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Oncology and Hematology Associates of SW Virginia-Raonoke

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Facility Name

Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Lifehouse

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Macquarie University Hospital

City

Macquarie Park

State/Province

New South Wales

ZIP/Postal Code

2109

Country

Australia

Facility Name

Calvary Mater Newcastle; Medical Oncology

City

Waratah

State/Province

New South Wales

ZIP/Postal Code

2298

Country

Australia

Facility Name

Icon Cancer Foundation

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

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

St John of God Hospital

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

University Clinical Centre of the Republic of Srpska

City

Banja Luka

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

Hospital de Caridade de Ijui; Oncologia

City

Ijui

State/Province

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Santa Casa de Misericordia de Porto Alegre

City

Porto Alegre

State/Province

ZIP/Postal Code

90050-170

Country

Brazil

Facility Name

Hospital Sao Lucas - PUCRS

City

Porto Alegre

State/Province

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Instituto do Cancer do Estado de Sao Paulo - ICESP

City

Sao Paulo

State/Province

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Queen Elizabeth II Health Sciences Centre; Oncology

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Royal Victoria Hospital

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Facility Name

Hamilton Health Sciences - Juravinski Cancer Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

London Regional Cancer Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Lakeridge Health Oshawa; Oncology

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

The Ottawa Hospital Cancer Centre; Oncology

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

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

Jewish General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

CHU de Quebec Hotel-Dieu de Quebec

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

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

Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

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

Odense Universitetshospital, Onkologisk Afdeling R

City

Odense C

ZIP/Postal Code

5000

Country

Denmark

Facility Name

ICO Paul Papin; Oncologie Medicale.

City

Angers

ZIP/Postal Code

49055

Country

France

Facility Name

Hopital Saint Andre; Oncologie 2

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Centre Francois Baclesse; Urologie Gynecologie

City

Caen

ZIP/Postal Code

14076

Country

France

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

Institut Paoli Calmettes; Oncologie Medicale

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Centre D'Oncologie de Gentilly; Oncology

City

Nancy

ZIP/Postal Code

54100

Country

France

Facility Name

APHP - Hospital Saint Louis

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

City

Paris

ZIP/Postal Code

75908

Country

France

Facility Name

ICO - Site René Gauducheau

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Institut Gustave Roussy; Departement Oncologie Medicale

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

Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Klinikum d.Universität München Campus Großhadern

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Universitätsklinikum Tübingen; Klinik für Urologie

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Az. Osp. Cardarelli; Divisione Di Oncologia

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

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

Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

City

Roma

State/Province

Lazio

ZIP/Postal Code

00152

Country

Italy

Facility Name

Irccs Ospedale San Raffaele;Oncologia Medica

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

Facility Name

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20162

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

Nagoya University Hospital; Urology

City

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Chiba Cancer Center

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

Kyushu University Hospital

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Gunma University Hospital

City

Gunma

ZIP/Postal Code

371-8511

Country

Japan

Facility Name

Hokkaido University Hospital

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

University of Tsukuba Hospital; Urology

City

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

Iwate Medical University Hospital

City

Iwate

ZIP/Postal Code

028-3695

Country

Japan

Facility Name

Yokohama City University Hospital

City

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

Kitasato University Hospital

City

Kanagawa

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

Kumamoto University Hospital

City

Kumamoto

ZIP/Postal Code

860-8556

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

Osaka International Cancer Institute; Urology

City

Osaka

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

Osaka Metropolitan University Hospital

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Osaka University Hospital

City

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Kindai University Hospital

City

Osaka

ZIP/Postal Code

589-8511

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

The Cancer Institute Hospital, JFCR; Urology

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

Tokyo Women's Medical University

City

Tokyo

ZIP/Postal Code

162-0054

Country

Japan

Facility Name

Chungnam National University Hospital

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

National Cancer Center

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

003-722

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

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

Cancerología

City

Queretaro

ZIP/Postal Code

76090

Country

Mexico

Facility Name

Centro Oncologico Estatal ISSEMYM

City

Toluca

ZIP/Postal Code

50180

Country

Mexico

Facility Name

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Saint Elizabeth's Hospital

City

Warsaw

ZIP/Postal Code

02-616

Country

Poland

Facility Name

MAGODENT Sp. z o.o.

City

Warsaw

ZIP/Postal Code

04-125

Country

Poland

Facility Name

ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic

City

Barnaul

State/Province

Altaj

ZIP/Postal Code

656049

Country

Russian Federation

Facility Name

GBUZ Nizhegorodskay Region: Clinical Diagnostic Center

City

Nizhni Novgorod

State/Province

Niznij Novgorod

ZIP/Postal Code

603001

Country

Russian Federation

Facility Name

P.A. Herzen Oncological Inst. ; Oncology

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

City Clinical Oncology Hospital

City

Moscow

ZIP/Postal Code

143423

Country

Russian Federation

Facility Name

National University Hospital

City

Singapore

ZIP/Postal Code

117599

Country

Singapore

Facility Name

National Cancer Centre; Medical Oncology

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

8208

Country

Spain

Facility Name

Hospital Universitario Reina Sofia; Servicio de Oncologia

City

Córdoba

State/Province

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Univ Vall d'Hebron; Servicio de Oncologia

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clínic i Provincial; Servicio de Oncología

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Duran i Reynals; Oncologia

City

Barcelona

ZIP/Postal Code

08907

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 12 de Octubre; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Taichung Veterans General Hospital; Division of Urology

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Facility Name

National Taiwan Uni Hospital; Dept of Oncology

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Chang Gung Medical Foundation-Linkou, Urinary Oncology

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Chulalongkorn Hospital; Medical Oncology

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

City

Chiangmai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Songklanagarind Hospital; Department of Oncology

City

Songkhla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Hacettepe University Medical Faculty

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

City

Edirne

ZIP/Postal Code

22770

Country

Turkey

Facility Name

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

City

Istanbul

ZIP/Postal Code

34300

Country

Turkey

Facility Name

Clatterbridge Cancer Centre

City

Bebington

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

Queen Elizabeth Hospital

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Royal Blackburn Hospital

City

Blackburn

ZIP/Postal Code

BB2 3HH

Country

United Kingdom

Facility Name

Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Barts Health NHS Trust - St Bartholomew's Hospital

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Royal Free Hospital; Dept of Oncology

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Christie Hospital Nhs Trust; Medical Oncology

City

Manchester

ZIP/Postal Code

M2O 4BX

Country

United Kingdom

Facility Name

Churchill Hospital; Oxford Cancer and Haematology Centre

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

Southampton General Hospital; Medical Oncology

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Royal Marsden Hospital; Dept of Medical Oncology

City

Sutton

ZIP/Postal Code

SM2 5PT

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

34940781

Citation

Motzer RJ, Powles T, Atkins MB, Escudier B, McDermott DF, Alekseev BY, Lee JL, Suarez C, Stroyakovskiy D, De Giorgi U, Donskov F, Mellado B, Banchereau R, Hamidi H, Khan O, Craine V, Huseni M, Flinn N, Dubey S, Rini BI. Final Overall Survival and Molecular Analysis in IMmotion151, a Phase 3 Trial Comparing Atezolizumab Plus Bevacizumab vs Sunitinib in Patients With Previously Untreated Metastatic Renal Cell Carcinoma. JAMA Oncol. 2022 Feb 1;8(2):275-280. doi: 10.1001/jamaoncol.2021.5981.

Results Reference

derived

PubMed Identifier

32127394

Citation

Atkins MB, Rini BI, Motzer RJ, Powles T, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Gurney H, Oudard S, Uemura M, Lam ET, Grullich C, Quach C, Carroll S, Ding B, Zhu QC, Piault-Louis E, Schiff C, Escudier B. Patient-Reported Outcomes from the Phase III Randomized IMmotion151 Trial: Atezolizumab + Bevacizumab versus Sunitinib in Treatment-Naive Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2020 Jun 1;26(11):2506-2514. doi: 10.1158/1078-0432.CCR-19-2838. Epub 2020 Mar 3.

Results Reference

derived

PubMed Identifier

31079938

Citation

Rini BI, Powles T, Atkins MB, Escudier B, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Lee JL, Hawkins R, Ravaud A, Alekseev B, Staehler M, Uemura M, De Giorgi U, Mellado B, Porta C, Melichar B, Gurney H, Bedke J, Choueiri TK, Parnis F, Khaznadar T, Thobhani A, Li S, Piault-Louis E, Frantz G, Huseni M, Schiff C, Green MC, Motzer RJ; IMmotion151 Study Group. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2019 Jun 15;393(10189):2404-2415. doi: 10.1016/S0140-6736(19)30723-8. Epub 2019 May 9.

Results Reference

derived

Learn more about this trial

A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC)

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