Triple Negative Breast Cancer Clinical Trial
— ASCENT-04Official title:
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
| Status | Recruiting |
| Enrollment | 440 |
| Est. completion date | February 2027 |
| Est. primary completion date | February 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: - Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening. - Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and = 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence. - Individuals presenting with de novo metastatic TNBC are eligible for this study. - TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen. - Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally. - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. - Demonstrates adequate organ function - Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. - Individuals with 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 prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor. - Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment. - Individuals 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. - Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor. - Have an active second malignancy. - Have active serious infection requiring antibiotics. - Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. - Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. - Has an active autoimmune disease that has required systemic treatment in the past 2 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Británico de Buenos Aires | Buenos Aires | |
| Argentina | Instituto de Oncología Ángel H. Roffo | Caba | |
| Argentina | Fundacion CORI para la Investigacioy y Prevención del Cancer | Capital | |
| Argentina | Instituto de Oncologia de Rosario | Rosario | |
| Argentina | CAIPO Centro Para La Atención Integral Del Pacient | 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 | Peter MacCallum Cancer Centre | Parkville | Victoria |
| 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 | 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 | |
| Belgium | Institut Jules Bordet | Anderlecht | |
| 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 - Associacao de Combate ao Cancer em Goias - ACCG | Goiânia | |
| Brazil | Centro de Pesquisa Clinica Em Oncologia - ONCOSITE | Ijui | |
| Brazil | Hospital de Clinicas de Porto Alegre - HCPA | Itajai | |
| Brazil | Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho - Hospital Amarval Carvalho | Jau | |
| Brazil | Associacao Hosptialar Moinos de Vento - Hospital Moinhos de Vento | Porto Alegre | |
| Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | |
| Brazil | Hospital Sao Lucas da PUCRS | Porto Alegre | |
| Brazil | Instituto Nacional de Câncer - Brazil | Rio de Janeiro | |
| Brazil | Núcleo de Oncologia da Bahia | Salvador | |
| Brazil | CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Centro Universitário FMABC | Santo Andre | |
| Brazil | Clinica de Pesquisas e Centro de Estudos em Oncolo | São Paulo | |
| Brazil | Fundação Pio XII - Hospital de Câncer de Barretos | São Paulo | |
| Brazil | Nucleo de Pesquisa Clinica da Rede Sao Camilo | São Paulo | |
| Brazil | Real e Benemerita Associacao Portuguesa de Beneficencia - Hospital Beneficencia Portuguesa (BP) - Unidade Paulista | São Paulo | |
| Canada | Tom Baker Cancer Centre | Calgary | |
| 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 | Princess Margaret Cancer Centre - University Health Network | Ontario | |
| Canada | Ottawa Hospital - General Campus | Ottawa | |
| 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 Cancer Pontificia Universidad Catolica | Santiago Region | |
| Chile | James Lind Centro de Investigacion del Cancer | Temuco | |
| Czechia | Masarykuv Onkologicky Ustav, Klinika Komplexni Onkologicke Pece | Brno | |
| Czechia | Fakultní Thomayerova nemocnice | Hradec Kralove | |
| Czechia | Fakultní Nemocnice Hradec Králové | Hradec Králové | |
| Czechia | Fakultni nemocnice Olomouc, Onkologicka klinika | Olomouc | |
| Czechia | Vseobecna Fakultni Nemocnice v Praze, Onkologicka klinika | Prague | |
| Czechia | Fakultní Nemocnice Královské 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 | Polyclinique Bordeaux Nord Aquitaine | Bordeaux | |
| France | Hôpital Morvan, Institut de cancérologie | Brest | |
| France | Centre de Lutte contre le Cancer - François Bacles | Caen | |
| France | Centre Jean Perrin | Clermont Ferrand | |
| France | Centre Leon Berard | Lyon | |
| France | Institut Paoli-Calmettes | Marseille CEDEX 9 | |
| France | Centre de Cancérologie du Grand Montpellier | Montpellier | |
| France | Institut Régional du Cancer de Montpellier | Montpellier Cedex 5 | |
| 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 | Marienhospital Bottrop | Bottrop | |
| Germany | Universitätsklinikum Erlangen, Frauen klinik | Erlangen | |
| Germany | Kliniken Essen-Mitte - Evangelische Huyssens-Stift | Essen | |
| Germany | Praxis für interdisziplinäre Onkologie & Hämatolog | Freiburg | |
| Germany | : Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Facharztzentrum Eppendorf | Hamburg | |
| Germany | Nationales Centrum für Tumorerkrankungen | Heidelberg | |
| Germany | Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale | Köln | |
| Germany | Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie | Lübeck | |
| Germany | Universitatsklinikum Mannheim GmBH, Frauenklinik | Mannheim | |
| Germany | EV. Krankenhaus Bethesda - Johanniter GmbH, Station 1 Brustzentrum Niederrhein | Mönchengladbach | |
| Germany | Klinik und Poliklinik für Frauenheilkunde | München | |
| Germany | Rotkreuzklinikum Munchen Frauenklinik | München | |
| Germany | Universitätsklinikum Münster, Bereich Senologie an der klinik fur Frauenheilkunde und Gerburtschilfe | Munster | |
| Germany | Universitatsklinikum Tubingen | Tübingen | |
| Germany | St. Josefs-Hospital Wiesbaden GmbH, Gynakologie und Geburtshilfe | Wiesbaden | |
| Hong Kong | Department of Medicine, Queen Mary Hospital | Hong Kong | |
| Hong Kong | Hong Kong Sanatorium and Hospital | Hong Kong | |
| Hong Kong | Tuen Mun Hospital | Hong Kong | |
| Hong Kong | Prince of Wales Hospital - Hong Kong | New Territories | |
| Hungary | Orszagos Onkologiai Intezet | Budapest | |
| Hungary | Uzsoki Utcai Kórház | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Központ | Debrecen | |
| Hungary | Petz Aladár Egyetemi Oktató Kórház - Gy?r | 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 "Giovanni 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 | IRCCS 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 | Ospedale San Raffaele | Milano | |
| Italy | Centro Ricerca Fase I, Fondazione IRCSS San Gerado dei Tintori | Monza | |
| Italy | AOU "Luigi Vanvitelli" | Napoli | |
| Italy | Oncologia Medica Senologica Sperimentale - Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Napoli | |
| Italy | AOU Maggiore della Carita | Novara | |
| Italy | Istituto Oncologico Veneto - IRCCS | Padova | |
| Italy | S.O.C Oncologia Medica, Nuovo Ospedale di Prato Santo Stefano | Prato | |
| Italy | Policlinico di Roma | 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 International Cancer Institute | Chuo-ku | |
| Japan | NHO 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 | The 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 | 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 - Korea | 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 | 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 S.A. de C.V. | Chihuahua | |
| Mexico | Cryptex Investigación Clínica | Ciudad de Mexico | |
| Mexico | 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 | 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 w | Siedlce | |
| Poland | Wojskowy Instytut Medyczny | Warsaw | |
| Poland | Narodowy Instytut Onkologii im.Marii Marii Sklodowskiejs | Warszawa | |
| Puerto Rico | Ponce Medical School Foundation Inc. | Ponce | |
| Puerto Rico | Clinical Research Puerto Rico | San Juan | |
| Singapore | Curie Oncology | Singapore | |
| Singapore | National Cancer Centre Singapore | Singapore | |
| Singapore | National University Hospital | Singapore | |
| Singapore | Raffles Hospital | Singapore | |
| South Africa | Hopelands Cancer Centre | Hilton | |
| South Africa | The Medical Oncology Centre of Rosebank | Johannesburg | |
| South Africa | University of Pretoria | Pretoria | |
| Spain | Hospital Teresa Herrera - Materno Infantil | A Coruña | |
| Spain | Hospital Clinic Barcelona | Barcelona | |
| Spain | Hospital Clínic de 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 Marañón | Madrid | |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
| Spain | MD Anderson Cancer Centre 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 Sankt Gallen | St. Gallen | |
| Switzerland | Kantonsspital Winterthur | Winterthur | |
| Switzerland | Brust-Zentrum Zurich | Zürich | |
| Taiwan | Changhua Christian Hospital | Changhua | |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
| Taiwan | Taipei Medical University-Shuang Ho Hospital | New Taipei City | |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | Chi Mei Hospital, Liouying | Tainan City | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| Taiwan | Taipei Veterans General Hospital | Taipei City | |
| Taiwan | Linkou Chang Gung Memorial Hospital | Taoyuan | |
| Turkey | Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. Merkezi | Adana | |
| Turkey | Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve A | Ankara | |
| Turkey | Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital | 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 | NHS Lothian | Edinburgh | |
| United Kingdom | Clinical Trials Unit Lvl 0 Cancer Research UK Beatson Institute | Glasgow | |
| United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds | |
| United Kingdom | : Barts Health NHS Trust, St Hospital | 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 | London | |
| United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | |
| United States | Advent Health Medical Group | Altamonte Springs | Florida |
| United States | SCRI - Florida Cancer Specialists - North Region R,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 and 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 | Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | Winship Cancer Institute of Emory University,550 Peachtree St NE | Atlanta | Georgia |
| United States | Winship Cancer Institute of Emory University,5665 Peachtree Dunwoody Road | Atlanta | Georgia |
| United States | Rocky Mountain Cancer Centers,1700 South Potomac Street | Aurora | Colorado |
| United States | Texas Oncology-Austin | Austin | Texas |
| United States | Texas Oncology-Austin,4101 James Casey, Suite 100 | Austin | Texas |
| United States | Texas Oncology-Austin,901 West 38th Street | Austin | Texas |
| United States | University of Miami - Sylvester Comprehensive Cancer Center,2801 NE 213th St | Aventura | Florida |
| 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 | Hematology Oncology Clinic - Baton Rouge | Baton Rouge | Louisiana |
| United States | Summit Medical Group,1 Diamond Hill Road | Berkeley Heights | New Jersey |
| United States | Magee-Womens Hospital of UPMC,200 Oxford Drive | Bethel Park | Pennsylvania |
| 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 | SCRI - Florida Cancer Specialists - North Region R,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 and 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 | 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 | University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center) | Chicago | Illinois |
| United States | SCRI - Florida Cancer Specialists - North Region R,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 | The Ohio State University Wexner Medical Center Clinical Laboratories | Columbus | Ohio |
| United States | Zangmeister Cancer Center | Columbus | Ohio |
| United States | University of Miami - Sylvester Comprehensive Cancer Center,5555 Ponce De Leon Blvd | Coral Gables | Florida |
| United States | University of California Irvine Health Chao Family,1640 Newport Blvd | Costa Mesa | California |
| United States | Magee-Womens Hospital of UPMC,3 St. Francis Way | Cranberry Township | Pennsylvania |
| 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 | SCRI - Florida Cancer Specialists - West Palm Beach,224 Memorial Medical Parkway, Suite 300 | Daytona Beach | Florida |
| United States | University of Miami - Sylvester Comprehensive Cancer Center,1192 East Newport Center Drive | Deerfield 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 | City of Hope | Duarte | California |
| United States | Northside Hospital,3855 Pleasant Hill Rd., Suite 480 | Duluth | Georgia |
| United States | Regional Cancer Care Associates - East Brunswick | East Brunswick | New Jersey |
| 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 | Huntsman Cancer Institute, University of Utah,165 North University Avenue | Farmington | Utah |
| United States | Summit Medical Group | Florham Park | New Jersey |
| 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 | Regulatory Management Only: TRIO-US Central Administration | Fort Wayne | Indiana |
| United States | The Center for Cancer and Blood Disorders - Magnolia | Fort Worth | Texas |
| United States | Tennessee Oncology, PLLC,4488 Carothers Parkway | Franklin | Tennessee |
| United States | SCRI - Florida Cancer Specialists - North Region R,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 | Magee-Womens Hospital of UPMC,200 Village Drive | Greensburg | Pennsylvania |
| United States | Ascension St. John Hospital | Grosse Pointe Woods | Michigan |
| United States | John Theurer Cancer Center | Hackensack | New Jersey |
| United States | Rutgers Cancer Institute of New Jersey,2575 Klockner Road | Hamilton | New Jersey |
| United States | Magee-Womens Hospital of UPMC,4300 Londonberry Road | Harrisburg | Pennsylvania |
| United States | Comprehensive Cancer Centers of Nevada - Central V,10001 S. Eastern Avenue, Suite 108 | Henderson | Nevada |
| United States | Comprehensive Cancer Centers of Nevada - Central V,1501 Wigwam Parkway, Suite 1300 | Henderson | Nevada |
| United States | Comprehensive Cancer Centers of Nevada - Central V,2460 W. Horizon Ridge Parkway | Henderson | Nevada |
| United States | Tennessee Oncology, PLLC,353 New Shackle Island Road | Hendersonville | Tennessee |
| United States | Tennessee Oncology, PLLC,5653 First Blvd. | Hermitage | Tennessee |
| United States | University of Miami - Sylvester Comprehensive Cancer Center,3850 Hollywood Blvd | Hollywood | Florida |
| United States | Genesis Cancer and Blood Institute | Hot Springs | Arkansas |
| United States | Genesis Cancer and Blood Institute,1456 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 Texas MD Anderson Cancer Center | Houston | Texas |
| United States | University of Texas MD Anderson Cancer Center,1155 Pressler St | Houston | Texas |
| 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 | SCRI - Florida Cancer Specialists - North Region R,100 Highland Avenue | Largo | Florida |
| United States | Comprehensive Cancer Centers of Nevada - Central V | Las Vegas | Nevada |
| United States | Comprehensive Cancer Centers of Nevada - Central V,653 North Town Center Drive, Suite 402 | Las Vegas | Nevada |
| United States | Comprehensive Cancer Centers of Nevada - Central V,7445 Peak Drive | Las Vegas | Nevada |
| United States | Comprehensive Cancer Centers of Nevada - Central V,9280 W. Sunset Road Suite 100 | Las Vegas | Nevada |
| United States | Tennessee Oncology, PLLC,103 Physicians Way | Lebanon | Tennessee |
| United States | SCRI - Florida Cancer Specialists - North Region R,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 | Virginia Cancer Institute,7501 Right Flank Road | Mechanicsville | Virginia |
| United States | University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida |
| United States | University of Miami - Sylvester Comprehensive Cancer Center,1400 NW 12th Ave | Miami | Florida |
| United States | University of Miami - Sylvester Comprehensive Cancer Center,8932 S.W. 97 Ave | Miami | Florida |
| United States | Perlmutter Cancer Center - Manhattan - 34th Street,259 First Street | Mineola | New York |
| United States | Regional Cancer Care Associates - East Brunswick,9 Centre Drive | Monroe | New Jersey |
| United States | Magee-Womens Hospital of UPMC,400 Oxford Drive | Monroeville | Pennsylvania |
| United States | Tennessee Oncology, PLLC,1840 Medical Center Parkway | Murfreesboro | Tennessee |
| United States | Florida Cancer Specialists,1100 Goodlette Road | 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 | Regional Cancer Care Associates - East Brunswick,34-36 Progress Street | New Brunswick | New Jersey |
| 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 | Perlmutter Cancer Center - Manhattan - 34th Street | 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 | City of Hope,1601 Avocado Ave | Newport | California |
| 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 | SCRI - Florida Cancer Specialists - North Region R,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 | University of California Irvine Health Chao Family | Orange | California |
| United States | SCRI - Florida Cancer Specialists - North Region R,2824 Enterprise Rd | Orange City | Florida |
| United States | Advent Health Medical Group,2501 North Orange Ave | Orlando | Florida |
| United States | SCRI - Florida Cancer Specialists - North Region R,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 | City of Hope,209 Fair Oaks Ave | Pasadena | California |
| United States | New York Cancer & Blood Specialists - Port Jeffers,365 East Main St. | Patchogue | New York |
| United States | Virginia Cancer Institute,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 | Magee-Womens Hospital of UPMC,9100 Babcock Boulevard | Pittsburgh | Pennsylvania |
| United States | University of Miami - Sylvester Comprehensive Cancer Center,8100 SW 10 Street | Plantation | Florida |
| 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, PC,265 N. Broadway | Portland | Oregon |
| United States | Northwest Cancer Specialists, PC,5050 NE Hoyt St. | Portland | Oregon |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Rhode Island Hospital,164 Summit Ave, Fain 275A | Providence | Rhode Island |
| 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 Institute | Richmond | Virginia |
| United States | Virginia Cancer Institute,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 | Mayo Clinic | Rochester | Minnesota |
| United States | SCRI - Florida Cancer Specialists - North Region R | Saint Petersburg | Florida |
| United States | SCRI - Florida Cancer Specialists - North Region R,1201 Fifth Avenue North | Saint Petersburg | Florida |
| United States | Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah |
| United States | Huntsman Cancer Institute, University of Utah,1280 E. Stringham Avenue | Salt Lake City | Utah |
| 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 | St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare | Santa Rosa | California |
| United States | Florida Cancer Specialists,1970 Golf Street | Sarasota | Florida |
| United States | Florida Cancer Specialists,600 North Cattlemen Road | Sarasota | Florida |
| United States | Magee-Womens Hospital of UPMC,100 Fairfield Dr | Seneca | Pennsylvania |
| 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 | Regional Cancer Care Associates - East Brunswick,75 Veronica Avenue | Somerset | New Jersey |
| United States | Rutgers Cancer Institute of New Jersey,110 Rehill Ave | Somerville | New Jersey |
| United States | Huntsman Cancer Institute, University of Utah,5126 West Daybreak Parkway | South Jordan | Utah |
| United States | The West Clinic, PLLC dba West Cancer Center,7668 Airways Blvd | Southaven | Mississippi |
| United States | Ascension Providence Hospital Southfield Cancer Center | Southfield | Michigan |
| United States | SCRI - Florida Cancer Specialists - North Region R,7154 Medical Center Drive | Spring Hill | Florida |
| United States | Piedmont Cancer Institute - Atlanta,1240 Eagles Landing Pkwy | Stockbridge | Georgia |
| United States | SCRI - Florida Cancer Specialists - West Palm Beach,301 SE Ocean Blvd, Suite 102 | Stuart | Florida |
| United States | SCRI - Florida Cancer Specialists - North Region R,3402 West Dr. Martin Luther King Jr. Boulevard | Tampa | Florida |
| United States | SCRI - Florida Cancer Specialists - North Region R,4100 Waterman Way | Tavares | Florida |
| United States | SCRI - Florida Cancer Specialists - North Region R,1400 US Highway 441 N | The Villages | Florida |
| United States | Rocky Mountain Cancer Centers,8820 Huron Street | Thornton | Colorado |
| United States | Northwest Cancer Specialists, PC | Tigard | Oregon |
| United States | Rutgers Cancer Institute of New Jersey,99 Highway 37 West | Toms River | New Jersey |
| United States | City of Hope,5215 Torrance Blvd | Torrance | California |
| United States | Torrance Memorial Physician Network - Cancer Care | Torrance | California |
| United States | SCRI - Florida Cancer Specialists - North Region R,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 | City of Hope,1100 San Bernardino Rd | Upland | California |
| United States | Northwest Cancer Specialists, PC,210 SE 136th Avenue | Vancouver | Washington |
| United States | Florida Cancer Specialists,836 Sunset Lake Blvd | Venice | Florida |
| United States | SCRI - 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 | Magee-Womens Hospital of UPMC,470 Johnson Road | Washington | Pennsylvania |
| United States | The Center for Cancer and Blood Disorders - Magnolia,920 Santa Fe Drive | Weatherford | Texas |
| United States | SCRI - 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 | SCRI - 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 | Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield Road | Winfield | Illinois |
| United States | SCRI - Florida Cancer Specialists - North Region R,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 | Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, Singapore, 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 33 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 53 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 complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response. | Randomization up to approximately 53 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 objective PD or death from any cause (whichever comes first). | Randomization up to approximately 53 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 53 months | |
| Secondary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to 53 months plus 30 days | ||
| Secondary | Percentage of Participants Experiencing Clinical Laboratory Abnormalities | First dose date up to 53 months plus 30 days | ||
| Secondary | Time to Deterioration (TTD) in Global Health Status/Quality of Life (QoL) Scale 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). | Randomization up to approximately 53 months | |
| Secondary | TTD of Pain Score as Measured by 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). | Randomization up to approximately 53 months | |
| Secondary | TTD of Fatigue Score as Measured by 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant). | Randomization up to approximately 53 months | |
| Secondary | TTD of Physical Functioning Domain Score as Measured by 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant). | Randomization up to approximately 53 months | |
| Secondary | TTD of Role Functioning Score as Measured by 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant). | Randomization up to approximately 53 months |
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