Triple Negative Breast Cancer Clinical Trial
— ASCENT-03Official title:
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
| Status | Recruiting |
| Enrollment | 540 |
| Est. completion date | May 2027 |
| Est. primary completion date | May 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: - Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC) - Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity - Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue - Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and = 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence - Individuals presenting with de novo metastatic TNBC are eligible - Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Demonstrates adequate organ function - Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception - Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease Key Exclusion Criteria: - Positive serum pregnancy test or women who are lactating - Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment - Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry - May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible - Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor - Active second malignancy - Active serious infection requiring antibiotics - Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease - Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Británico de Buenos Aires | Buenos Aires | |
| Argentina | Instituto de Oncologia Angel H.Roffo | Caba | |
| Argentina | Fundacion CORI para la Investigacion y Prevencion del Cancer | Capital | |
| Argentina | Instituto de Oncología de Rosario | Rosario | |
| Argentina | Centro para la Atencion Integral del Paciente Oncologico Centro Médico C.A.I.P.O | San Miguel de Tucumán | |
| Argentina | Clinica Viedma | Viedma | |
| Australia | Cancer Research SA (CRSA) | Adelaide | South Australia |
| Australia | Border Medical Oncology | Albury | New South Wales |
| Australia | Monash Medical Centre | Clayton | Victoria |
| Australia | Icon Cancer Centre Hobart | Hobart | Tasmania |
| Australia | Saint George Hospital - Australia | Kogarah | New South Wales |
| Australia | Austin Hospital | Melbourne | Victoria |
| Australia | Breast Cancer Research Center - Western Australia | Nedlands | Western Australia |
| Australia | Mater Hospital - North Sydney | North Sydney | New South Wales |
| Australia | Mater Misericordiae Limited and Mater Research Limited | South Brisbane | Queensland |
| Australia | GenesisCare - North Shore | St Leonards | New South Wales |
| Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
| Austria | Universitätsklinikum Graz | Graz | |
| Austria | Medizinische Universität Innsbruck | Innsbruck | |
| Austria | Ordensklinikum Linz GmbH Barmherzige Schwestern | Linz | |
| Austria | Landeskrankenhaus Salzburg | Salzburg | |
| Austria | Universitätsklinikum Sankt Pölten | Sankt Poelten | |
| Austria | Medizinische Universität Wien | Wien | |
| Austria | Landesklinikum Wiener Neustadt | Wiener Neustadt | |
| Belgium | Algemeen Ziekenhuis Klina | Brasschaat | |
| Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
| Belgium | Universitair Ziekenhuis Brussel | Brussels | |
| Belgium | Grand Hopital de Charleroi - Notre Dame | Charleroi | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | UZ Leuven | Leuven | |
| Belgium | Centre Hospitalier Universitaire Université Cathol | Namur | |
| Brazil | Hospital Araújo Jorge - Associação de Combate ao Câncer em Goiás - ACCG | Goiânia | |
| Brazil | ONCOSITE - Centro de Pesquisa Clinica em Oncologia | Ijui | |
| Brazil | Catarina Pesquisa Clínica | Itajai | |
| Brazil | Hospital Amaral Carvalho | Jau | |
| Brazil | Hospital de Clinicas de Porto Alegre - HCPA | Porto Alegre | |
| Brazil | Hospital Moinhos de Vento | Porto Alegre | |
| Brazil | Hospital Sao Lucas da PUCRS | Porto Alegre | |
| Brazil | Instituto Nacional de Câncer - INCA - HCIII | Rio de Janeiro | |
| Brazil | Núcleo de Oncologia da Bahia | Salvador | |
| Brazil | CEPHO - Centro de Estudos e PesquisaS de Hematologia e Oncologia | Santo Andre | |
| Brazil | Clinica de Pesquisas e Centro de Estudos em Oncolo | São Paulo | |
| Brazil | Fundação Pio XII - Hospital de Amor de Barretos | São Paulo | |
| Brazil | Nucleo de Pesquisa Clinica da Rede Sao Camilo | São Paulo | |
| Brazil | Real e Portuguesa de Beneficéncia - Hospital Beneficéncia Portuguesa (BP) - Unidade Paulista | São Paulo | |
| Canada | Cross Cancer Institute | Edmonton | |
| Canada | QEII Health Sciences Centre | Halifax | |
| Canada | Grand River Regional Cancer Centre at Grand River Hospital | Kitchener | |
| Canada | London Health Sciences Centre | London | |
| Canada | McGill University Health Centre | Montreal | |
| Canada | Jewish General Hospital | Montréal | |
| Canada | Ottawa Hospital - General Campus | Ottawa | |
| Canada | CISSS du Bas-Saint-Laurent - Hôpital régional de Rimouski | Rimouski | |
| Canada | Mount Sinai Hospital | Toronto | |
| Canada | Sunnybrook Research Institute | Toronto | |
| Canada | British Columbia Cancer - Vancouver | Vancouver | |
| Chile | Oncovida - Santiago | Providencia | |
| Chile | Clínica Alemana | Santiago | |
| Chile | Clínica IRAM | Santiago DE CHILE | |
| Chile | Centro de Oncología de Precisión | Santiago Region | |
| Chile | James Lind Centro de Investigacion del Cancer | Temuco | |
| China | Beijing Cancer Hospital | Beijing | |
| China | Cancer Hospital Chinese Academy of Medical Sciences | Beijing | |
| China | Peking University People's Hospital | Beijing | |
| China | The First Medical Center of Chinese PLA General Hospital | Beijing | |
| China | Sichuan Cancer Hospital | Chengdu | |
| China | West China Hospital, Sichuan University | Chengdu | |
| China | Chongqing University Cancer Hospital | Chongqing | |
| China | Deyang People's Hospital | Deyang | |
| China | Sun Yat-Sen University Cancer Center | Guangzhou | |
| China | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | |
| China | Harbin Medical University Cancer Hospital | Harbin | |
| China | Anhui Provincial Cancer Hospital | Hefei | |
| China | The Second Hospital of Anhui Medical University | Hefei | |
| China | The Second Hospital of Jilin University | Jilin Sheng | |
| China | Shandong Cancer Hospital | Jinan | |
| China | Nanchang People's hospital | Nanchang | |
| China | Hubei Cancer Hospital | Wuhan | |
| China | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | |
| China | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | |
| China | The First Affiliated Hospital of Wenzhou Medical University | Zhejiang | |
| China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Zhejiang | |
| Czechia | Masarykuv onkologicky ustav, klinika komplexni onkologickie pece | Brno | |
| Czechia | Fakultní Thomayerova nemocnice | Hradec Kralove | |
| Czechia | Fakultni nemocnice Hradec Kravlove, Klinika onkologie a radioterapie | Hradec Králové | |
| Czechia | Fakultni nemocnice Olomouc, Onkologicka klinika | Olomouc | |
| Czechia | Vseobecna Fakultni Nemocnice v Praze | Prague | |
| Czechia | Fakultni nemocnice Karlovske Vinohrady, Radioterapeuticka a onkologicka klinika | Praha | |
| France | Sainte Catherine Institut du Cancer Avignon Provence | Avignon | |
| France | Centre Hospitalier Régional et Universitaire de Be | Besancon | |
| France | Hôpital Morvan, Institut de cancérologie | Brest | |
| France | Centre francois Baclesse | Caen | |
| France | Centre Jean Perrin | Clermont Ferrand | |
| France | Centre de Cancérologie du Grand Montpellier | Montpellier | |
| France | Hôpital Privé du Confluent | Nantes | |
| France | Hospices Civils de Lyon Hôpital Lyon Sud | Pierre-benite | |
| France | Centre Armoricain de Radiothérapie, dImagerie Méd | Plerin | |
| France | Centre Eugène Marquis | Rennes Cedex | |
| France | Institut Claudius Regaud - IUCT-O | Toulouse | |
| France | Institut Gustave Roussy | Villejuif | |
| Germany | Helios Klinikum Berlin-Buch | Berlin | |
| Germany | Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie, | Bonn | |
| Germany | Universitätsklinikum Erlangen, Frauen klinik | Erlangen | |
| Germany | Kliniken Essen-Mitte - Evangelische Huyssens-Stift Breast Unit | Essen | |
| Germany | Praxis für interdisziplinäre Onkologie & Hämatolog | Freiburg | |
| Germany | Facharztzentrum Eppendorf | Hamburg | |
| Germany | Universitatsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Nationales Centrum für Tumorerkrankungen - Heidelb | Heidelberg | |
| Germany | Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale | Köln | |
| Germany | Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie | Lübeck | |
| Germany | Universitatsklinikum Mannheim GmBH, Frauenklinik | Mannheim | |
| Germany | Evangelisches Krankenhaus Bethesda Mönchengladbach | Mönchengladbach | |
| Germany | Klinik und Poliklinik für Frauenheilkunde | München | |
| Germany | Rotkreuzklinikum Munchen | München | |
| Germany | Universitätsklinikum Münster, Bereich Senologie an der klinik fur Frauenheilkunde und Gerburtschilfe | Munster | |
| Germany | Universitätsklinikum Tübingen | Tübingen | |
| Germany | St. Josefs-Hospital Wiesbaden GmbH , Gynäkologie und Geburtshilfe | Wiesbaden | |
| Hong Kong | Hong Kong Integrated Oncology Centre | Hong Kong | |
| Hong Kong | Queen Mary Hospital | Hong Kong | |
| Hong Kong | Tuen Mun Hospital | Hong Kong | |
| Hong Kong | Prince of Wales Hospital - Hong Kong | New Territories | |
| Hong Kong | Queen Mary Hospital | Pok Fu Lam | |
| Hungary | Uzsoki Utcai Kornaz, Onkoradiologiai Osztaly | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Központ | Debrecen | |
| Hungary | Petz Aladar Egyetemi Oktaté Kérhaz - Osztaly | Gyor | |
| Israel | Soroka Medical Center | Beer-Sheva | |
| Israel | Rambam Health Care Campus | Haifa | |
| Israel | Hadassah - Hebrew University Medical Center | Jerusalem | |
| Israel | Shaare Zedek Medical Center | Jerusalem | |
| Israel | Meir Medical Center | Kfar Saba | |
| Israel | Rabin Medical Center | Petah Tikva | |
| Israel | Kaplan Medical Center | Rehovot | |
| Israel | Sheba Medical Center Hospital - Tel Hashomer | Tel Aviv | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Italy | IRCCS Istituto Tumori "G.Paolo II" | Bari | |
| Italy | SSD Oncologia Medica Addarii-Zamagni, IRCSS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola | Bologna | |
| Italy | UO Oncologia, ASST degli Spedali Civili di Brescia | Brescia | |
| Italy | IRCSS Ospedale Policlinico San Martino | Genova GE | |
| Italy | S.C. Oncologia medica, ASST di Lecco | Lecco | |
| Italy | Presidio Ospedaliero di Lucca | Lucca | |
| Italy | Ospedale Generale Provinciale - Macerata | Macerata | |
| Italy | Istituto Europeo di Oncologia | Milan | |
| Italy | Fondazione IRCCS - Istituto Nazionale dei Tumori | Milano | |
| Italy | Azienda Socio Sanitaria Territoriale | Monza | |
| Italy | Oncologia Medica Senologica Sperimentale - Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Napoli | |
| Italy | Azienda Ospedaliero-Universitaria Maggiore della C | Novara | |
| Italy | Istituto Oncologico Veneto - IRCCS | Padova | |
| Italy | S.O.C Patologia Clinica (Laboratorio Analisi), Nuovo Ospedale di Prato - Santo Stefano | Prato | |
| Italy | AOU Policlinico Umberto I | Roma | |
| Italy | Fondazione Policlinico Universitario Agostino Geme | Rome | |
| Italy | Azienda Ospedaliera Universitaria Senese - Losped | Siena | |
| Japan | Aichi Cancer Center Hospital | Aichi | |
| Japan | Tohoku University Hospital | Aoba-ku | |
| Japan | Juntendo University Hospital | Bunkyo-ku | |
| Japan | Chiba Cancer Center | Chuo-ku | |
| Japan | Osaka Prefectural Hospital Organization - Osaka In | Chuo-ku | |
| Japan | Shikoku Cancer Center | Ehime | |
| Japan | Fukushima Medical University Hospital | Fukushima | |
| Japan | Saitama Cancer Center | Inamachi | |
| Japan | Hakuaikai Sagara Hospital | Kagoshima-shi | |
| Japan | Tokai University Hospital | Kanagawa | |
| Japan | National Cancer Center Hospital East | Kashiwa | |
| Japan | Cancer Institute Hospital of JFCR | Koto-ku | |
| Japan | Kumamoto University Hospital | Kumamoto- shi | |
| Japan | Kure Medical Center And Chugoku Cancer Center | Kure | |
| Japan | Mie University Hospital | Mie | |
| Japan | National Hospital Organization Kyushu Cancer Center | Minami-ku | |
| Japan | Nagoya City University Hospital | Nagoya | |
| Japan | Nagoya University Hospital | Nagoya | |
| Japan | Hiroshima City Hiroshima Citizens Hospital | Naka-ku | |
| Japan | Niigata Cancer Center Hospital | Niigata-shi | |
| Japan | Okayama University Hospital | Okayama | |
| Japan | Gunma Prefectural Cancer Center | Ota | |
| Japan | Kyoto University Hospital | Sakyo-ku | |
| Japan | Hokkaido Cancer Center | Sapporo | |
| Japan | Shizuoka Cancer Center | Shizuoka | |
| Japan | Shizuoka General Hospital | Shizuoka-city | |
| Japan | Osaka University Hospital | Suita | |
| Japan | Showa University Hospital | Tokyo | |
| Japan | Kanagawa Cancer Center | Yokohama | |
| Korea, Republic of | National Cancer Center | Goyang-si Gyeonggi-do | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | |
| Malaysia | Hospital Pulau Pinang | Georgetown | |
| Malaysia | Hospital Sultan Ismail | Johor Bahru | |
| Malaysia | Hospital Kuala Lumpur | Kuala Lumpur | |
| Malaysia | Pantai Hospital Kuala Lumpur | Kuala Lumpur | |
| Malaysia | University Malaya Medical Centre (UMMC) | Kuala Lumpur | |
| Malaysia | Institut Kanser Negara | Putrajaya | |
| Malaysia | Hospital Wanita dan Kanak-Kanak Sabah | Sabah | |
| Malaysia | Sarawak General Hospital | Sarawak | |
| Mexico | Icaro Investigaciones en Medicina | Chihuahua | |
| Mexico | Cryptex Investigación Clínica | Ciudad de Mexico | |
| Mexico | Sinacor - Centro para el Desarrollo de la Medicina | Culiacan | |
| Mexico | Panamerican Clinical Research Mexico - Guadalajara | Guadalajara | |
| Mexico | Medical Care and Research S.A. de C.V. | Merida | |
| Mexico | Fucam A.C. | México | |
| Mexico | Avix Investigacion Clinica S.C. | Monterrey | |
| Mexico | Oncológico Potosino | San Luis Potosi | |
| Mexico | FAICIC Clínical Research | Veracruz | |
| Mexico | iBiomed - Investigacion Biomedica para el Desarrol | Zapopan | |
| Netherlands | Amphia Ziekenhuis - Breda Langendijk | Breda | |
| Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
| Netherlands | Medisch Centrum Leeuwarden | Leeuwarden | |
| Netherlands | Maastricht Universitair Medisch Centrum | Maastricht | |
| Netherlands | Erasmus Medisch Centrum | Rotterdam | |
| Poland | Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej | Gliwice | |
| Poland | SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego | Opole | |
| Poland | Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie | Poznan | |
| Poland | Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II | Siedlce | |
| Poland | Wojskowy Instytut Medyczny | Warsaw | |
| Poland | Narodowy Instytut Onkologii im.Marii Marii Sklodowskiej | Warszawa | |
| Puerto Rico | Ponce Medical School Foundation Inc. | Ponce | |
| Puerto Rico | Clinical Research Puerto Rico | San Juan | |
| Romania | Spitalul Clinic Filantropia | Bucharest | |
| Romania | Institutal Oncologic, Prof. Dr Ion Chiricuta | Cluj-Napoca | |
| Romania | SC Medisprof SRL | Cluj-Napoca | |
| Romania | Centrul De Oncologie Sf Nectarie | Craiova | |
| Romania | S.C. Oncomed S.R.L | Timisoara | |
| Singapore | Curie Oncology | Singapore | |
| Singapore | National University Hospital | Singapore | |
| Singapore | Raffles Hospital | Singapore | |
| Slovakia | Národný onkologický ústav | Bratislava | |
| Slovakia | Onkologicky Ustav Sv. Alzbety | Bratislava | |
| Slovakia | Vychodoslovensky onkologicky ustav, a.s., Oddelenie klinickej onkologie | Košice | |
| Slovakia | Nemocnica Partizánske | Partizánske | |
| South Africa | Hopelands Cancer Centre | Hilton | |
| South Africa | The Medical Oncology Centre of Rosebank | Johannesburg | |
| South Africa | Wits Clinical Research | Johannesburg | |
| South Africa | University of Pretoria | Pretoria | |
| Spain | Hospital Teresa Herrera - Materno Infantil | A Coruña | |
| Spain | Hospital Clinic Barcelona | Barcelona | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital Universitari Dexeus | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebrón | Barcelona | |
| Spain | Hospital Universitario de Basurto | Bilbo | |
| Spain | Hospital Universitari Arnau de Vilanova | Lleida | |
| Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
| Spain | MD Anderson Cancer Center Madrid | Madrid | |
| Spain | Hospital Universitario Virgen de la Victoria | Malaga | |
| Spain | Hospital General Universitario Morales Meseguer | Murcia | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Hospital Unviersitario Virgen del Rocio | Sevilla | |
| Spain | Hospital Universitario de Canarias | Tenerife | |
| Spain | Hospital Clínico Universitario de Valencia | Valencia | |
| Switzerland | Kantonsspital Baden | Baden | |
| Switzerland | Kantonsspital Baselland - Standort Liestal | Liestal | |
| Switzerland | Kantonsspital St.Gallen | St. Gallen | |
| Switzerland | Kantonsspital Winterthur | Winterthur | |
| Switzerland | Brust-Zentrum AG | Zürich | |
| Taiwan | Changhua Christian Hospital | Changhua | |
| Taiwan | Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Hualien City | |
| Taiwan | E-DA Cancer Hospital | Kaohsiung City | |
| Taiwan | Kaohsiung | Kaohsiung City | |
| Taiwan | Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare | New Taipei City | |
| Taiwan | Taichung | Taichung | |
| Taiwan | Taichung Veterans General Hospital | Taichung | |
| Taiwan | Chi Mei Hospital, Lioying | Tainan City | |
| Taiwan | National Cheng Kung University Hospital | Tainan City | |
| Taiwan | MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital | Taipei | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| Taiwan | Tri-Service General Hospital | Taipei | |
| Taiwan | Chang Gung Memorial Hospital, Linkou | Taoyuan City | |
| Turkey | Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. Merkezi | Adana | |
| Turkey | Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi | Ankara | |
| Turkey | Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve A | Ankara | |
| Turkey | Hacettepe Üniversitesi Hastanesi | Ankara | |
| Turkey | Memorial Ankara Hastanesi | Ankara | |
| Turkey | Trakya Universitesi Tip Fakultesi Hastanesi | Edirne | |
| Turkey | Istanbul Il Saglik Mudurlugu Goztepe Prof. Dr. Sul | Istanbul | |
| Turkey | Medipol Mega Universite Hastanesi | Istanbul | |
| Turkey | Ege Universitesi Hastanesi | Izmir | |
| Turkey | Medicana International Izmir Hastanesi | Izmir | |
| Turkey | Acibadem Maslak Hastanesi | Sariyer | |
| Turkey | VKV Amerikan Hastanesi | Sisli | |
| United Kingdom | Gloucestershire Hospitals NHS Foundation Trust | Cheltenham | |
| United Kingdom | Cancer Research UK Beatson Institute | Glasgow | |
| United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds | |
| United Kingdom | Barts Health NHS Trust | London | |
| United Kingdom | Guy's and Saint Thomas' NHS Foundation Trust | London | |
| United Kingdom | Royal Free London NHS Foundation Trust | London | |
| United Kingdom | University College London Hospitals NHS Foundation | London | |
| United States | AdventHealth Medical Group | Altamonte Springs | Florida |
| United States | Florida Cancer Specialists - North Region Research Office,750 Orienta Ave | Altamonte Springs | Florida |
| United States | Alaska Oncology and Hematology | Anchorage | Alaska |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | The Center for Cancer & Blood Disorders - Magnolia,515 W. Mayfield Rd. | Arlington | Texas |
| United States | Northside Hospital,125 King Avenue | Athens | Georgia |
| United States | Northside Hospital | Atlanta | Georgia |
| United States | Northside Hospital,5670 Peachtree Dunwoody Rd. | Atlanta | Georgia |
| United States | Piedmont Cancer Institute - Atlanta | Atlanta | Georgia |
| United States | Piedmont Cancer Institute - Atlanta,1267 Hwy 54W | Atlanta | Georgia |
| United States | Rocky Mountain Cancer Centers,1700 South Potomac Street | Aurora | Colorado |
| United States | Texas Oncology PA | Austin | Texas |
| United States | Texas Oncology PA,4101 James Casey, Suite 100 | Austin | Texas |
| United States | Texas Oncology PA,901 West 38th Street | Austin | Texas |
| United States | New York Cancer & Blood Specialists - Port Jeffers,72 East Main St. | Babylon | New York |
| United States | Cancer Institute Ascension Saint Agnes | Baltimore | Maryland |
| United States | Mercy Medical Center | Baltimore | Maryland |
| United States | Hematology Oncology Clinic - Baton Rouge | Baton Rouge | Louisiana |
| United States | Summit Medical Group Eastside Clinic,1 Diamond Hill Road | Berkeley Heights | New Jersey |
| United States | Northside Hospital,308 Deep South Farm Rd, Suite 200 | Blairsville | Georgia |
| United States | Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A | Bonita Springs | Florida |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Rocky Mountain Cancer Centers | Boulder | Colorado |
| United States | Florida Cancer Specialists,3630 Manatee Avenue West | Bradenton | Florida |
| United States | Florida Cancer Specialists,5985 Silver Falls Run | Bradenton | Florida |
| United States | Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave. | Brandon | Florida |
| United States | Montefiore Medical Center - Montefiore Medical Park | Bronx | New York |
| United States | New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4 | Bronx | New York |
| United States | New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360 | Bronx | New York |
| United States | University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200 | Burbank | California |
| United States | The Center for Cancer & Blood Disorders - Magnolia,11805 South Freeway | Burleson | Texas |
| United States | Northside Hospital,228 Riverstone Dr. | Canton | Georgia |
| United States | Florida Cancer Specialists,1030 Commerce Creek Blvd | Cape Coral | Florida |
| United States | Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,157 Clinic Avenue | Carrollton | Georgia |
| United States | Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,100 Market Place Blvd | Cartersville | Georgia |
| United States | Novant Health Cancer Institute - Forsyth,125 Queens Road, Suite 650 | Charlotte | North Carolina |
| United States | Virginia Oncology Associates,744 N. Battlefield Blvd | Chesapeake | Virginia |
| United States | Orchard Healthcare Research Inc,2845 North Sheridan Road, 1st Floor | Chicago | Illinois |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center) | Chicago | Illinois |
| United States | Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road | Clearwater | Florida |
| United States | Rocky Mountain Cancer Centers,2312 N. Nevada Avenue | Colorado Springs | Colorado |
| United States | Rocky Mountain Cancer Centers,6031 E. Woodman Rd. | Colorado Springs | Colorado |
| United States | Zangmeister Cancer Center | Columbus | Ohio |
| United States | Northside Hospital,1505 Northside Blvd, Suite 4600 | Cumming | Georgia |
| United States | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | Massachusetts General Hospital,102 Endicott Street | Danvers | Massachusetts |
| United States | Florida Cancer Specialists - West Palm Beach,224 Memorial Medical Parkway, Suite 300 | Daytona Beach | Florida |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital Drive | DeKalb | Illinois |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services Drive | DeKalb | Illinois |
| United States | Texas Oncology-Denison | Denison | Texas |
| United States | Rocky Mountain Cancer Centers,4700 E. Hale Parkway | Denver | Colorado |
| United States | Tennessee Oncology, PLLC,103 Natchez Park Drive | Dickson | Tennessee |
| United States | Northside Hospital,3855 Pleasant Hill Rd., Suite 480 | Duluth | Georgia |
| United States | Hematology Oncology Associates of Central New York | East Syracuse | New York |
| United States | Swedish Cancer Institute-First Hill,21632 Highway 99 | Edmonds | Washington |
| United States | Magee-Womens Hospital of UPMC,201 State Street, 6 Main | Erie | Pennsylvania |
| United States | Magee-Womens Hospital of UPMC,2500 West 12th Street | Erie | Pennsylvania |
| United States | Orchard Healthcare Research Inc,800 Austin Street, Suite 360, East Tower | Evanston | Illinois |
| United States | Summit Medical Group Eastside Clinic | Florham Park | New Jersey |
| United States | Holy Cross Hospital, Inc | Fort Lauderdale | Florida |
| United States | Florida Cancer Specialists | Fort Myers | Florida |
| United States | Florida Cancer Specialists,8260 Gladiolus Dr | Fort Myers | Florida |
| United States | Florida Cancer Specialists,8981 Colonial Center Drive | Fort Myers | Florida |
| United States | Fort Wayne Medical Oncology and Hematology - Fort | Fort Wayne | Indiana |
| United States | The Center for Cancer & Blood Disorders - Magnolia | Fort Worth | Texas |
| United States | Tennessee Oncology, PLLC,4488 Carothers Parkway | Franklin | Tennessee |
| United States | Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road | Gainesville | Florida |
| United States | Tennessee Oncology, PLLC,225 Big Station Camp Blvd | Gallatin | Tennessee |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall Road | Geneva | Illinois |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall Road | Geneva | Illinois |
| United States | The West Clinic, PLLC dba West Cancer Center | Germantown | Tennessee |
| United States | Nebraska Cancer Specialists,2730 W. Faidley Ave | Grand Island | Nebraska |
| United States | Ascension St. John Hospital | Grosse Pointe Woods | Michigan |
| United States | Magee-Womens Hospital of UPMC,4300 Londonberry Road | Harrisburg | Pennsylvania |
| United States | Tennessee Oncology, PLLC,353 New Shackle Island Road | Hendersonville | Tennessee |
| United States | Tennessee Oncology, PLLC,5653 First Blvd. | Hermitage | Tennessee |
| United States | Genesis Cancer and Blood Institute | Hot Springs | Arkansas |
| United States | Genesis Cancer and Blood Institute,1455 Higdon Ferry Road Suite B. | Hot Springs | Arkansas |
| United States | Oncology Consultants | Houston | Texas |
| United States | Oncology Consultants,1631 North Loop West | Houston | Texas |
| United States | Oncology Consultants,925 Gessner | Houston | Texas |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | Swedish Cancer Institute-First Hill,751 NE Blakely Drive | Issaquah | Washington |
| United States | Queens Hospital Center | Jamaica | New York |
| United States | Rutgers Cancer Institute of New Jersey,414 Grand Street | Jersey City | New Jersey |
| United States | Saint Bernards Medical Center | Jonesboro | Arkansas |
| United States | The University of Kansas Cancer Center,2000 Olathe Blvd | Kansas City | Kansas |
| United States | The University of Kansas Cancer Center,2750 Clay Edwards Drive | Kansas City | Missouri |
| United States | The University of Kansas Cancer Center,8700 North Green Hills Road | Kansas City | Missouri |
| United States | University of California San Diego Moores Cancer | La Jolla | California |
| United States | University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200 | Laguna Hills | California |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland Road | Lake Forest | Illinois |
| United States | Rocky Mountain Cancer Centers,11750 West 2nd Place | Lakewood | Colorado |
| United States | Rutgers Cancer Institute of New Jersey,600 River Avenue | Lakewood | New Jersey |
| United States | Florida Cancer Specialists - North Region Research Office,100 Highland Avenue | Largo | Florida |
| United States | Tennessee Oncology, PLLC,103 Physicians Way | Lebanon | Tennessee |
| United States | Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway | Lecanto | Florida |
| United States | The University of Kansas Cancer Center,4881 N.E. Goodview Circle | Lee's Summit | Missouri |
| United States | Rocky Mountain Cancer Centers,22 West Dry Creek Circle | Littleton | Colorado |
| United States | Rutgers Cancer Institute of New Jersey,94 Old Short Hills Road | Livingston | New Jersey |
| United States | Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway | Lone Tree | Colorado |
| United States | Rutgers Cancer Institute of New Jersey,300 Second Ave | Long Branch | New Jersey |
| United States | Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210 | Longmont | Colorado |
| United States | Cancer and Blood Specialty Clinic | Los Alamitos | California |
| United States | Norton Cancer Institute - Saint Matthews | Louisville | Kentucky |
| United States | Norton Cancer Institute - Saint Matthews,234 E. Gray Strret | Louisville | Kentucky |
| United States | Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd | Louisville | Kentucky |
| United States | Norton Cancer Institute - Saint Matthews,676 S. Floyd Street | Louisville | Kentucky |
| United States | Northside Hospital,308 Coliseum Dr. | Macon | Georgia |
| United States | Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC | Marietta | Georgia |
| United States | Magee-Womens Hospital of UPMC,2035 Technology Parkway | Mechanicsburg | Pennsylvania |
| United States | Virginia Cancer Specialists, PC,7501 Right Flank Road | Mechanicsville | Virginia |
| United States | Tennessee Oncology, PLLC,1840 Medical Center Parkway | Murfreesboro | Tennessee |
| United States | Florida Cancer Specialists,1100 Goodlette Road | Naples | Florida |
| United States | Florida Cancer Specialists,681 4th Avenue North | Naples | Florida |
| United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC,2004 Hayes Street | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC,3443 Dickerson Road | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC,397 Wallace Road | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC,4220 Harding Rd | Nashville | Tennessee |
| United States | Tennessee Oncology, PLLC,SCRI Oncology Partners | Nashville | Tennessee |
| United States | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey |
| United States | New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr. | New Hyde Park | New York |
| United States | NYP/Columbia Univeresity Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
| United States | Rutgers Cancer Institute of New Jersey,150 Bergen St. | Newark | New Jersey |
| United States | Rutgers Cancer Institute of New Jersey,201 Lyons Avenue | Newark | New Jersey |
| United States | Piedmont Cancer Institute - Atlanta,775 Poplar Road | Newnan | Georgia |
| United States | Virginia Oncology Associates,1051 Loftis Blvd Suite 100 | Newport News | Virginia |
| United States | Massachusetts General Hospital,2014 Washington St | Newton | Massachusetts |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut |
| United States | Rush University Medical Center,520 South Maple Ave | Oak Park | Illinois |
| United States | Florida Cancer Specialists - North Region Research Office,4945 SW 49th Place | Ocala | Florida |
| United States | Nebraska Cancer Specialists | Omaha | Nebraska |
| United States | Nebraska Cancer Specialists,8303 Dodge Street | Omaha | Nebraska |
| United States | Florida Cancer Specialists - North Region Research Office,2824 Enterprise Rd | Orange City | Florida |
| United States | AdventHealth Medical Group,2501 North Orange Ave | Orlando | Florida |
| United States | Florida Cancer Specialists - North Region Research Office,70 W. Gore Street | Orlando | Florida |
| United States | The University of Kansas Cancer Center,10710 Nall Avenue | Overland Park | Kansas |
| United States | The University of Kansas Cancer Center,10730 Nall Avenue | Overland Park | Kansas |
| United States | The University of Kansas Cancer Center,12200 W. 110th Street | Overland Park | Kansas |
| United States | Nebraska Cancer Specialists,611 Fenwick Dr | Papillion | Nebraska |
| United States | Saint Bernards Medical Center,4000 Linwood Drive | Paragould | Arkansas |
| United States | New York Cancer & Blood Specialists - Port Jeffers,365 East Main St. | Patchogue | New York |
| United States | Capital Health Medical Center - Hopewell | Pennington | New Jersey |
| United States | Sacred Heart Heatlh System, Inc., d/b/a Ascension Sacred Heart | Pensacola | Florida |
| United States | Virginia Cancer Specialists, PC,210 Medical Park Boulevard | Petersburg | Virginia |
| United States | University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania |
| United States | Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania |
| United States | Magee-Womens Hospital of UPMC,5115 Centre Avenue | Pittsburgh | Pennsylvania |
| United States | Florida Cancer Specialists,22395 Edgewater Drive | Port Charlotte | Florida |
| United States | New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4 | Port Jefferson | New York |
| United States | New York Cancer & Blood Specialists - Port Jeffers | Port Jefferson Station | New York |
| United States | New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset Hwy | Port Jefferson Station | New York |
| United States | Northwest Cancer Specialists, P.C,265 N. Broadway | Portland | Oregon |
| United States | Northwest Cancer Specialists, P.C,5050 NE Hoyt St. | Portland | Oregon |
| United States | Rocky Mountain Cancer Centers,3676 Parker Blvd | Pueblo | Colorado |
| United States | Rocky Mountain Cancer Centers,525 W. 15th Street | Pueblo | Colorado |
| United States | Virginia Cancer Specialists, PC | Richmond | Virginia |
| United States | Virginia Cancer Specialists, PC,1401 Johnston-Willis Drive | Richmond | Virginia |
| United States | New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4 | Riverhead | New York |
| United States | Florida Cancer Specialists - North Region Research Office | Saint Petersburg | Florida |
| United States | Florida Cancer Specialists - North Region Research Office,1201 Fifth Avenue North | Saint Petersburg | Florida |
| United States | Mays Cancer Center | San Antonio | Texas |
| United States | University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240 | San Luis Obispo | California |
| United States | Sansum Clinic | Santa Barbara | California |
| United States | University of California Los Angeles - Jonsson Comprehensive Cancer Center | Santa Monica | California |
| United States | University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600 | Santa Monica | California |
| United States | University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304 | Santa Monica | California |
| United States | Sacred Heart Heatlh System, Inc., d/b/a Ascension Sacred Heart,27 Mack Bayou Loop | Santa Rosa Beach | Florida |
| United States | Florida Cancer Specialists,1970 Golf Street | Sarasota | Florida |
| United States | Florida Cancer Specialists,600 North Cattlemen Road | Sarasota | Florida |
| United States | Swedish Cancer Institute-First Hill | Seattle | Washington |
| United States | Swedish Cancer Institute-First Hill,747 Broadway | Seattle | Washington |
| United States | Tennessee Oncology, PLLC,120 Frank Martin Road | Shelbyville | Tennessee |
| United States | Orchard Healthcare Research Inc | Skokie | Illinois |
| United States | Tennessee Oncology, PLLC,300 Stonecrest Blvd | Smyrna | Tennessee |
| United States | Sansum Clinic,2040 Viborg Road | Solvang | California |
| United States | Rutgers Cancer Institute of New Jersey,110 Rehill Ave | Somerville | New Jersey |
| United States | The West Clinic, PLLC dba West Cancer Center,7668 Airways Blvd | Southaven | Mississippi |
| United States | Ascension Providence Hospital | Southfield | Michigan |
| United States | Florida Cancer Specialists - North Region Research Office,7154 Medical Center Drive | Spring Hill | Florida |
| United States | Piedmont Cancer Institute - Atlanta,1240 Eagles Landing Pkwy | Stockbridge | Georgia |
| United States | Florida Cancer Specialists - West Palm Beach,301 SE Ocean Blvd, Suite 102 | Stuart | Florida |
| United States | Florida Cancer Specialists - North Region Research Office,3402 West Dr. Martin Luther King Jr. Boulevard | Tampa | Florida |
| United States | Florida Cancer Specialists - North Region Research Office,4100 Waterman Way | Tavares | Florida |
| United States | Florida Cancer Specialists - North Region Research Office,1400 US Highway 441 N | The Villages | Florida |
| United States | Rocky Mountain Cancer Centers,8820 Huron Street | Thornton | Colorado |
| United States | Northwest Cancer Specialists, P.C | Tigard | Oregon |
| United States | Rutgers Cancer Institute of New Jersey,99 Highway 37 West | Toms River | New Jersey |
| United States | Torrance Memorial Physician Network - Cancer Care | Torrance | California |
| United States | Florida Cancer Specialists - North Region Research Office,9320 State Road 54 | Trinity | Florida |
| United States | Arizona Oncology Associates, PC-Hope | Tucson | Arizona |
| United States | Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road | Tucson | Arizona |
| United States | Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd | Tucson | Arizona |
| United States | Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd. | Tucson | Arizona |
| United States | Northwest Cancer Specialists, P.C,210 SE 136th Avenue | Vancouver | Washington |
| United States | Florida Cancer Specialists,836 Sunset Lake Blvd | Venice | Florida |
| United States | Florida Cancer Specialists,901 South Tamiami Trail | Venice | Florida |
| United States | Florida Cancer Specialists - West Palm Beach,3730 7th Terrace, Suite 101 | Vero Beach | Florida |
| United States | Virginia Oncology Associates,1950 Glenn Mitchell Drive | Virginia Beach | Virginia |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver Parkway | Warrenville | Illinois |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver Parkway | Warrenville | Illinois |
| United States | The Center for Cancer & Blood Disorders - Magnolia,920 Santa Fe Drive | Weatherford | Texas |
| United States | Florida Cancer Specialists - West Palm Beach,1037 S. State Road 7, Bldg B, Suite 303 | Wellington | Florida |
| United States | Rutgers Cancer Institute of New Jersey,100 State Route 36 | West Long Branch | New Jersey |
| United States | Florida Cancer Specialists - West Palm Beach | West Palm Beach | Florida |
| United States | University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100 | Westlake Village | California |
| United States | The University of Kansas Cancer Center | Westwood | Kansas |
| United States | Novant Health Cancer Institute - Forsyth,2131 S. 17th Street | Wilmington | North Carolina |
| United States | Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield Road | Winfield | Illinois |
| United States | Novant Health Cancer Institute - Forsyth | Winston-Salem | North Carolina |
| United States | Florida Cancer Specialists - North Region Research Office,460 N Orlando Ave | Winter Park | Florida |
| United States | Magee-Womens Hospital of UPMC,1703 Innovation Drive | York | Pennsylvania |
| United States | Hematology Oncology Clinic - Baton Rouge,1673 E Mount Please Drive | Zachary | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, Romania, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first). | Randomization up to approximately 22 months | |
| Secondary | Overall Survival (OS) | OS is defined as the time from the date of randomization until death due to any cause. | Randomization up to approximately 57 months | |
| Secondary | Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1 | ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response. | Randomization up to approximately 57 months | |
| Secondary | Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1 | DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first). | Randomization up to approximately 57 months | |
| Secondary | Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1 | TTR is defined as the time from the date of randomization until the first documentation of CR or PR. | Randomization up to approximately 57 months | |
| Secondary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to approximately 57 months plus 30 days | ||
| Secondary | Percentage of Participants Experiencing Clinical Laboratory Abnormalities | First dose date up to approximately 57 months plus 30 days | ||
| Secondary | Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30). | The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) to assess 15 scales; 1 global health status/quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social), and 9 symptom/item scales(fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Randomization up to approximately 57 months | |
| Secondary | Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30 | TTD is defined as the time between the date of randomization and the date of assessment at which a patient experienced a deterioration (= 10 points deterioration from baseline in the fatigue scale) or death. | Randomization up to approximately 57 months |
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