A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)
Status: Recruiting
Location: See all (206) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC
‣ Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
⁃ Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
⁃ An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
⁃ A life expectancy of at least 3 months.
⁃ Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Locations
United States
California
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)
RECRUITING
Burbank
Colorado
Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)
RECRUITING
Grand Junction
Florida
Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)
RECRUITING
Jacksonville
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)
COMPLETED
Marietta
Kentucky
The University of Louisville, James Graham Brown Cancer Center ( Site 0121)
RECRUITING
Louisville
Massachusetts
University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)
COMPLETED
Worcester
Maine
New England Cancer Specialists ( Site 0143)
RECRUITING
Westbrook
Minnesota
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)
RECRUITING
Minneapolis
Mayo Clinic - Rochester ( Site 0148)
RECRUITING
Rochester
Mississippi
Hattiesburg Clinic Hematology/Oncology ( Site 0104)
RECRUITING
Hattiesburg
Nevada
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)
RECRUITING
Reno
Ohio
University Hospitals Cleveland Medical Center ( Site 0119)
RECRUITING
Cleveland
Oregon
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)
RECRUITING
Corvallis
Texas
Oncology Consultants P.A. ( Site 0129)
RECRUITING
Houston
Other Locations
Argentina
Hospital Aleman-Oncology ( Site 0300)
RECRUITING
Buenos Aires
Hospital Británico de Buenos Aires-Oncology ( Site 0304)
RECRUITING
Buenos Aires
Instituto Alexander Fleming ( Site 0306)
RECRUITING
Ciudad Autónoma De Buenos Aires
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
RECRUITING
Río Cuarto
Instituto de Oncología de Rosario ( Site 0301)
RECRUITING
Rosario
Australia
Grampians Health-Medical Oncology ( Site 3001)
COMPLETED
Ballarat Central
Northern Hospital ( Site 3003)
RECRUITING
Epping
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002)
RECRUITING
Port Macquarie
Westmead Hospital ( Site 3000)
RECRUITING
Westmead
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402)
RECRUITING
Barretos
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409)
RECRUITING
Porto Alegre
Instituto Nacional de Câncer - INCA ( Site 0405)
RECRUITING
Rio De Janeiro
Clinica Viver ( Site 0400)
RECRUITING
Santa Maria
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406)
RECRUITING
São José Do Rio Preto
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401)
RECRUITING
São Paulo
Canada
William Osler Health System ( Site 0203)
RECRUITING
Brampton
Trillium Health Partners - Credit Valley Hospital ( Site 0202)
RECRUITING
Mississauga
McGill University Health Centre ( Site 0200)
ACTIVE_NOT_RECRUITING
Montreal
Chile
Bradford Hill Norte ( Site 0516)
RECRUITING
Antofagasta
Bradfordhill-Clinical Area ( Site 0507)
RECRUITING
Santiago
FALP-UIDO ( Site 0509)
RECRUITING
Santiago
Orlandi Oncologia-Oncology ( Site 0504)
RECRUITING
Santiago
Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
RECRUITING
Talca
China
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101)
RECRUITING
Beijing
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100)
RECRUITING
Beijing
Jilin Province Tumor Hospital-oncology department ( Site 3126)
RECRUITING
Changchun
The Second Xiangya Hospital of Central South University ( Site 3138)
RECRUITING
Changsha
Sichuan Cancer hospital. ( Site 3105)
RECRUITING
Chengdu
West China Hospital, Sichuan University ( Site 3124)
RECRUITING
Chengdu
Fujian Provincial Cancer Hospital ( Site 3131)
RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3108)
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University ( Site 3134)
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3111)
RECRUITING
Hangzhou
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital-oncology of department ( Site 3132)
RECRUITING
Harbin
Second Affiliated hospital of Anhui Medical University ( Site 3133)
RECRUITING
Hefei
Jinan Central Hospital-oncology department ( Site 3122)
RECRUITING
Jinan
Shandong Cancer Hospital ( Site 3119)
RECRUITING
Jinan
Yunnan Province Cancer Hospital ( Site 3139)
RECRUITING
Kunming
Jiangxi Provincial Cancer Hospital ( Site 3143)
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127)
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121)
RECRUITING
Nanchang
The Second People's Hospital of Neijiang ( Site 3140)
RECRUITING
Neijiang
Shanghai Changhai Hospital ( Site 3125)
RECRUITING
Shanghai
The Second Hospital of Hebei Medical University ( Site 3135)
RECRUITING
Shijiazhuang
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 3114)
RECRUITING
Taizhou
Hubei Cancer Hospital ( Site 3106)
RECRUITING
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 3117)
RECRUITING
Wuhan
Wuhan Union Hospital ( Site 3130)
RECRUITING
Wuhan
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113)
RECRUITING
Wuxi
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107)
RECRUITING
Xiamen
Xiangyang Central Hospital-oncology department ( Site 3136)
RECRUITING
Xiangyang
The Affiliated Hospital of Xuzhou Medical College ( Site 3112)
RECRUITING
Xuzhou
Affiliated Hospital of Guangdong Medical University ( Site 3123)
RECRUITING
Zhanjiang
Henan Cancer Hospital ( Site 3116)
RECRUITING
Zhengzhou
Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0600)
RECRUITING
Bogotá
IMAT S.A.S ( Site 0602)
RECRUITING
Montería
Oncologos del Occidente ( Site 0603)
RECRUITING
Pereira
Denmark
Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1201)
RECRUITING
Aalborg
Regionshospitalet Gødstrup-Kræftklinikken ( Site 1204)
RECRUITING
Herning
Odense Universitetshospital ( Site 1200)
RECRUITING
Odense C
France
Clinique de l'Europe-Service de pneumologie ( Site 1304)
RECRUITING
Amiens
Centre Hospitalier de la Côte Basque ( Site 1300)
RECRUITING
Bayonne
L HOPITAL NORD OUEST ( Site 1310)
RECRUITING
Gleizé
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané ( Site 1303)
RECRUITING
Limoges
Hôpital Saint Joseph-ONCOLOGY ( Site 1308)
RECRUITING
Marseille
Institut Régional du Cancer Montpellier-Medical Oncology ( Site 1309)
RECRUITING
Montpellier
Centre d'Oncologie de Gentilly ( Site 1301)
RECRUITING
Nancy
Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1305)
RECRUITING
Poitiers
Germany
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1402)
RECRUITING
Berlin
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1403)
RECRUITING
Gera
LungenClinic Grosshansdorf-Onkologie ( Site 1401)
RECRUITING
Großhansdorf
Medizinische Hochschule Hannover-Department of Pneumology ( Site 1411)
RECRUITING
Hanover
Universitätsmedizin Johannes Gutenberg Universität Mainz- Klinik für Pneumologie ( Site 1404)
RECRUITING
Mainz
Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 1412)
RECRUITING
Marburg
Bethanien Krankenhaus Moers ( Site 1400)
RECRUITING
Moers
Klinikum Bogenhausen-Klinik für Pneumologie und Onkologische Pneumologie ( Site 1406)
RECRUITING
München
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik V ( Site 1409)
RECRUITING
München
Universitätsklinikum Münster - Albert Schweitzer Campus-Medizinische Klinik A ( Site 1410)
RECRUITING
Münster
Klinikum Nürnberg Nord-5. Med. Klinik ( Site 1407)
RECRUITING
Nuremberg
Italy
Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1804)
RECRUITING
Bari
AOU Renato Dulbecco ( Site 1801)
RECRUITING
Catanzaro
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori-Oncologia Medica ( Site 1807)
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1806)
RECRUITING
Roma
P.O. S. Maria della Misericordia Azienda Sanitaria Univers-Oncology Department ( Site 1803)
RECRUITING
Udine
Japan
Tokyo Metropolitan Komagome Hospital ( Site 3405)
RECRUITING
Bunkyo
National Hospital Organization Kyushu Cancer Center ( Site 3417)
RECRUITING
Fukuoka
National Hospital Organization Kyushu Medical Center ( Site 3416)
RECRUITING
Fukuoka
National Hospital Organization Himeji Medical Center ( Site 3426)
RECRUITING
Himeji
Kansai Medical University Hospital ( Site 3412)
RECRUITING
Hirakata
Hirosaki University Hospital ( Site 3429)
RECRUITING
Hirosaki
National Cancer Center Hospital East ( Site 3403)
RECRUITING
Kashiwa
St. Marianna University Hospital ( Site 3421)
RECRUITING
Kawasaki
Cancer Institute Hospital of JFCR ( Site 3404)
RECRUITING
Koto
Saiseikai Kumamoto Hospital ( Site 3419)
RECRUITING
Kumamoto
Kurume University Hospital ( Site 3418)
RECRUITING
Kurume
Matsusaka Municipal Hospital ( Site 3422)
RECRUITING
Matsusaka
National Hospital Organization Shikoku Cancer Center ( Site 3415)
RECRUITING
Matsuyama
Niigata Cancer Center Hospital ( Site 3409)
RECRUITING
Niigata
Osaka International Cancer Institute ( Site 3414)
RECRUITING
Osaka
Gunma Prefectural Cancer Center ( Site 3402)
RECRUITING
Ōta
Toho University Omori Medical Center ( Site 3420)
RECRUITING
Ōta-ku
Sendai Kousei Hospital ( Site 3400)
RECRUITING
Sendai
Tohoku University Hospital ( Site 3424)
RECRUITING
Sendai
Dokkyo Medical University Hospital ( Site 3401)
RECRUITING
Shimotsugagun
National Center for Global Health and Medicine ( Site 3406)
RECRUITING
Shinjuku
Tokyo Medical University Hospital ( Site 3407)
RECRUITING
Shinjuku
Iwate Medical University Hospital ( Site 3428)
RECRUITING
Shiwa-gun
Shizuoka Cancer Center ( Site 3410)
RECRUITING
Suntogun
Osaka Medical and Pharmaceutical University Hospital ( Site 3413)
RECRUITING
Takatsuki
Fujita Health University Hospital ( Site 3411)
RECRUITING
Toyoake
National Hospital Organization Yamaguchi Ube Medical Center ( Site 3423)
RECRUITING
Ube
National Hospital Organization Ureshino Medical Center ( Site 3427)
RECRUITING
Ureshino
Kanagawa Cancer Center ( Site 3408)
RECRUITING
Yokohama
Yokohama Municipal Citizen's Hospital ( Site 3425)
RECRUITING
Yokohama
Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0715)
RECRUITING
Guadalajara
Higiea Oncologia ( Site 0721)
RECRUITING
Mexico City
Axis Heilsa S. de R.L. de C.V. ( Site 0719)
RECRUITING
Monterrey
Oaxaca Site Management Organization S.C. ( Site 0718)
RECRUITING
Oaxaca City
Clinica Integral Internacional de Oncología ( Site 0714)
RECRUITING
Puebla City
Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0713)
RECRUITING
San Luis Potosí City
Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 1901)
RECRUITING
Breda
ETZ Elisabeth-Department of Pulmonary Diseases ( Site 1902)
RECRUITING
Tilburg
Isala, locatie Zwolle-Poli Longziekten ( Site 1903)
RECRUITING
Zwolle
Peru
Clinica Vallesur - AUNA ( Site 0854)
RECRUITING
Arequipa
Hospital Cayetano Heredia-Oncology ( Site 0855)
RECRUITING
Lima
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0850)
RECRUITING
Lima
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0851)
RECRUITING
Lima
Detecta Clínica ( Site 0853)
RECRUITING
Surquillo
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
RECRUITING
Bydgoszcz
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 2013)
RECRUITING
Grudziądz
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 2015)
RECRUITING
Krakow
SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital ( Site 2012)
RECRUITING
Lodz
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
RECRUITING
Przemyśl
Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2016)
RECRUITING
Torun
Instytut Gruźlicy i Chorób Płuc w Warszawie-3rd Dep of Lung Diseases and Oncology ( Site 2011)
RECRUITING
Warsaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
RECRUITING
Warsaw
Portugal
Hospital Dr. Nélio Mendonça ( Site 2105)
RECRUITING
Funchal
Hospital CUF - Tejo ( Site 2100)
RECRUITING
Lisbon
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 2104)
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2101)
RECRUITING
Lisbon
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 2103)
RECRUITING
Vila Nova De Gaia
Republic of Korea
Chungbuk National University Hospital-Internal medicine ( Site 3804)
RECRUITING
Cheongju-si
Keimyung University Dongsan Hospital CRC room 1 ( Site 3807)
RECRUITING
Daegu
National Cancer Center ( Site 3801)
RECRUITING
Goyang-si
Asan Medical Center-Lung Cancer Center ( Site 3805)
RECRUITING
Seoul
Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)
RECRUITING
Seoul
Ajou University Hospital-Hematology-Oncology ( Site 3806)
RECRUITING
Suwon
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3800)
RECRUITING
Suwon
Wonju Severance Christian Hospital ( Site 3808)
RECRUITING
Wŏnju
Spain
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2335)
RECRUITING
A Coruña
Hospital Universitari Vall d'Hebron-Oncology ( Site 2330)
RECRUITING
Barcelona
Hospital Jerez de la Frontera-UGC Oncología ( Site 2333)
RECRUITING
Jerez De La Frontera
H.R.U Malaga - Hospital General ( Site 2332)
RECRUITING
Málaga
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2331)
RECRUITING
Pozuelo De Alarcón
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2337)
RECRUITING
Seville
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2336)
RECRUITING
Valencia
Taiwan
National Taiwan University Hospital - Hsinchu branch ( Site 3901)
RECRUITING
Hsinchu
Chang Gung Memorial Hospital at Kaohsiung ( Site 3902)
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3904)
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital-Chest ( Site 3905)
RECRUITING
Taichung
Chi Mei Hospital - Liouying Branch ( Site 3908)
RECRUITING
Tainan City
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3903)
RECRUITING
Tainan City
Mackay Memorial Hospital ( Site 3909)
RECRUITING
Taipei
National Taiwan University Hospital-Oncology ( Site 3906)
RECRUITING
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 3907)
RECRUITING
Taipei City
Thailand
Chulalongkorn University-Medicine ( Site 4003)
RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital ( Site 4000)
RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 4001)
RECRUITING
Chiang Mai
Turkey
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2507)
RECRUITING
Adana
Ankara Bilkent Şehir Hastanesi ( Site 2500)
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2506)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501)
RECRUITING
Ankara
Memorial Ankara Hastanesi-Medical Oncology ( Site 2505)
RECRUITING
Ankara
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2503)
RECRUITING
Bornova
Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre-Oncolgyy-Hematology ( Site 2510)
RECRUITING
Denizli
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
RECRUITING
Istanbul
Ondokuz Mayıs Universitesi ( Site 2509)
RECRUITING
Samsun
Medipol Mega Universite Hastanesi-oncology ( Site 2508)
RECRUITING
Stanbul
Erciyes University ( Site 2511)
RECRUITING
Talas
United Kingdom
Kent and Canterbury Hospital-Oncology Research ( Site 2606)
RECRUITING
Canterbury
James Cook University Hospital ( Site 2604)
RECRUITING
Central Middlesbrough
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2605)
RECRUITING
London
Royal Free Hospital ( Site 2601)
RECRUITING
London
Queen Alexandra Hospital-Oncology Department ( Site 2603)
RECRUITING
Portsmouth
Viet Nam
K Hospital - National Cancer Hospital ( Site 4174)
RECRUITING
Hanoi
National Lung Hospital-Oncology Department ( Site 4175)
RECRUITING
Hanoi
Tam Anh General Hospital ( Site 4179)
RECRUITING
Hanoi
Cho Ray Hospital ( Site 4171)
RECRUITING
Ho Chi Minh City
Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 4173)
RECRUITING
Ho Chi Minh City
Thong Nhat Hospital ( Site 4170)
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2030-05-27
Participants
Target number of participants: 614
Treatments
Experimental: Pembrolizumab + Sacituzumab tirumotecan
Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
Active_comparator: Pembrolizumab
Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC