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

NCT02420821 | Completed Phase 3 Results

• 2 other identifiers: WO296372014-004684-20
• Study Type: interventional
• Target: 915
• Locations: 21 countries
• Sites: 154

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• Percentage of Participants Who Died of Any Cause in ITT Population

  Percentage of participants who died of any cause was reported.

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

• 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.

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

Secondary Outcomes (31)

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

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

• OS in PD-L1-Selected Population

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

• 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

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

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

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

• 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

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

Study Arms (2)

Atezolizumab + Bevacizumab

EXPERIMENTAL

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.

Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Bevacizumab

Sunitinib

ACTIVE COMPARATOR

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.

Drug: Sunitinib

Interventions

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

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.

Also known as: Tecentriq, MPDL3280A

Atezolizumab + Bevacizumab

Bevacizumab DRUG

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.

Also known as: Avastin

Atezolizumab + Bevacizumab

Sunitinib DRUG

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.

Also known as: Sutent

Sunitinib

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (154)

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

University of California at Irvine Medical Center; Department of Oncology

Orange, California, 92868, United States

Location

University of California

San Francisco, California, 94158, United States

Location

University of Colorado; Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Cancer Center; Medical Oncology

Boulder, Colorado, 80303, United States

Location

Georgetown U; Lombardi Comp Can

Washington D.C., District of Columbia, 20016-1468, United States

Location

Lynn Cancer Institute/Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Florida Cancer Specialists - Port Charlotte

Port Charlotte, Florida, 33980, United States

Location

Florida Cancer Specialist, North Region

St. Petersburg, Florida, 33705, United States

Location

Piedmont Cancer Institute, PC

Atlanta, Georgia, 30318, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Inst.

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Comprehensive Cancer Centers of Nevada - Eastern Avenue

Las Vegas, Nevada, 89169, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

New York Oncology Hematology,P.C.-Albany

Albany, New York, 12208, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Oncology Hematology Care Inc

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic Foundation; Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Northwest Cancer Specialists, P.C.

Tigard, Oregon, 97223, United States

Location

SCRI Tennessee Oncology Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Sarah Cannon Cancer Center and Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt Univ Medical Ctr

Nashville, Tennessee, 37232, United States

Location

Texas Oncology-Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Oncology and Hematology Associates of SW Virginia-Raonoke

Roanoke, Virginia, 24014, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Macquarie University Hospital

Macquarie Park, New South Wales, 2109, Australia

Location

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, 2298, Australia

Location

Icon Cancer Foundation

South Brisbane, Queensland, 4101, Australia

Location

Ashford Cancer Center Research

Kurralta Park, South Australia, 5037, Australia

Location

Austin Hospital; Medical Oncology

Heidelberg, Victoria, 3084, Australia

Location

St John of God Hospital

Murdoch, Western Australia, 6150, Australia

Location

University Clinical Centre of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

Hospital de Caridade de Ijui; Oncologia

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Hospital Sao Lucas - PUCRS

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

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Queen Elizabeth II Health Sciences Centre; Oncology

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Lakeridge Health Oshawa; Oncology

Oshawa, Ontario, L1G 2B9, Canada

Location

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 1Z5, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

CHU de Quebec Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Location

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, 779 00, Czechia

Location

Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

Prague, 128 08, Czechia

Location

Thomayerova nemocnice

Praha 4 - Krc, 140 59, Czechia

Location

Aarhus Universitetshospital; Kræftafdelingen

Aarhus N, 8200, Denmark

Location

Herlev Hospital; Afdeling for Kræftbehandling

Herlev, 2730, Denmark

Location

Odense Universitetshospital, Onkologisk Afdeling R

Odense C, 5000, Denmark

Location

ICO Paul Papin; Oncologie Medicale.

Angers, 49055, France

Location

Hopital Saint Andre; Oncologie 2

Bordeaux, 33075, France

Location

Centre Francois Baclesse; Urologie Gynecologie

Caen, 14076, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Paoli Calmettes; Oncologie Medicale

Marseille, 13273, France

Location

Centre D'Oncologie de Gentilly; Oncology

Nancy, 54100, France

Location

APHP - Hospital Saint Louis

Paris, 75475, France

Location

Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

Paris, 75908, France

Location

ICO - Site René Gauducheau

Saint-Herblain, 44805, France

Location

Institut Gustave Roussy; Departement Oncologie Medicale

Villejuif, 94805, France

Location

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

Dresden, 01307, Germany

Location

Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

Essen, 45122, Germany

Location

Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg

Heidelberg, 69120, Germany

Location

Klinikum d.Universität München Campus Großhadern

München, 81377, Germany

Location

Universitätsklinikum Tübingen; Klinik für Urologie

Tübingen, 72076, Germany

Location

Az. Osp. Cardarelli; Divisione Di Oncologia

Napoli, Campania, 80131, Italy

Location

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

Meldola, Emilia-Romagna, 47014, Italy

Location

A.O. Universitaria Policlinico Di Modena; Oncologia

Modena, Emilia-Romagna, 41100, Italy

Location

Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

Rome, Lazio, 00152, Italy

Location

Irccs Ospedale San Raffaele;Oncologia Medica

Milan, Lombardy, 20132, Italy

Location

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milan, Lombardy, 20162, Italy

Location

Fondazione IRCCS Policlinico San Matteo, Oncologia

Pavia, Lombardy, 27100, Italy

Location

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

Arezzo, Tuscany, 52100, Italy

Location

Nagoya University Hospital; Urology

Aichi, 466-8560, Japan

Location

Chiba Cancer Center

Chiba, 260-8717, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Gunma University Hospital

Gunma, 371-8511, Japan

Location

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

Location

University of Tsukuba Hospital; Urology

Ibaraki, 305-8576, Japan

Location

Yokohama City University Hospital

Kanagawa, 236-0004, Japan

Location

Kitasato University Hospital

Kanagawa, 252-0375, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

Location

Iwate Medical University Hospital

Numakunai, 028-3695, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute; Urology

Osaka, 541-8567, Japan

Location

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Kindai University Hospital

Osaka, 589-8511, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Toranomon Hospital

Tokyo, 105-8470, Japan

Location

Tokyo Medical and Dental University Hospital

Tokyo, 113-8519, Japan

Location

Nippon Medical School Hospital

Tokyo, 113-8603, Japan

Location

The Cancer Institute Hospital, JFCR; Urology

Tokyo, 135-8550, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Tokyo Women's Medical University

Tokyo, 162-0054, Japan

Location

Cancerología

Querétaro, 76090, Mexico

Location

Centro Oncologico Estatal ISSEMYM

Toluca, 50180, Mexico

Location

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

Lublin, 20-090, Poland

Location

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

Poznan, 60-569, Poland

Location

Saint Elizabeth's Hospital

Warsaw, 02-616, Poland

Location

MAGODENT Sp. z o.o.

Warsaw, 04-125, Poland

Location

ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic

Barnaul, Altayskiy Kray, 656049, Russia

Location

GBUZ Nizhegorodskay Region: Clinical Diagnostic Center

Nizhny Novgorod, Niznij Novgorod, 603001, Russia

Location

P.A. Herzen Oncological Inst. ; Oncology

Moscow, 125284, Russia

Location

City Clinical Oncology Hospital

Moscow, 143423, Russia

Location

National University Hospital

Singapore, 117599, Singapore

Location

National Cancer Centre; Medical Oncology

Singapore, 169610, Singapore

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 003-722, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, 8208, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, 14004, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial; Servicio de Oncología

Barcelona, 08036, Spain

Location

Hospital Duran i Reynals; Oncologia

Barcelona, 08907, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28007, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, 28041, Spain

Location

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Seville, 41013, Spain

Location

Taichung Veterans General Hospital; Division of Urology

Taichung, 407, Taiwan

Location

National Taiwan Uni Hospital; Dept of Oncology

Taipei, 100, Taiwan

Location

Chang Gung Medical Foundation-Linkou, Urinary Oncology

Taoyuan District, 333, Taiwan

Location

Chulalongkorn Hospital; Medical Oncology

Bangkok, 10330, Thailand

Location

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

Bangkok, 10400, Thailand

Location

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

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

Chiang Mai, 50200, Thailand

Location

Songklanagarind Hospital; Department of Oncology

Songkhla, 90110, Thailand

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, 22770, Turkey (Türkiye)

Location

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Istanbul, 34300, Turkey (Türkiye)

Location

Clatterbridge Cancer Centre

Bebington, CH63 4JY, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Royal Blackburn Hospital

Blackburn, BB2 3HH, United Kingdom

Location

Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

Cambridge, CB2 0QQ, United Kingdom

Location

Barts Health NHS Trust - St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Royal Free Hospital; Dept of Oncology

London, NW3 2QG, United Kingdom

Location

Christie Hospital Nhs Trust; Medical Oncology

Manchester, M2O 4BX, United Kingdom

Location

Churchill Hospital; Oxford Cancer and Haematology Centre

Oxford, OX3 7LJ, United Kingdom

Location

Southampton General Hospital; Medical Oncology

Southampton, SO16 6YD, United Kingdom

Location

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, SM2 5PT, United Kingdom

Location

Singleton Hospital; Pharmacy Department

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (4)

• Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

  PMID: 37146227 DERIVED

• 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.

  PMID: 34940781 DERIVED

• 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.

  PMID: 32127394 DERIVED

• 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.

  PMID: 31079938 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

atezolizumab; Bevacizumab; Sunitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

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

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 20, 2015
• Study Start: May 20, 2015
• Primary Completion: February 14, 2020
• Study Completion: December 13, 2021
• Last Updated: January 30, 2023
• Results First Posted: October 3, 2018

Record last verified: 2023-01

Locations

JP (23); BR (4); ME (2); BO (1); SG (2); AU (7); CZ (4); DE (5); ES (9); TU (3); TH (5); CA (10); DK (3); US (28); IT (8); PL (4); FR (11); KR (7); GB (11); RU (4); TW (3)