Clinical trial NCT06312176: A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
Official title: An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.

The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.


Eligibility criteria: Inclusion Criteria:

* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
* Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
* Is a chemotherapy candidate
* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
* Has adequate organ function
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

* Has breast cancer amenable to treatment with curative intent
* Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
* Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy

Primary outcomes:
measure: Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
timeFrame: Up to ~38 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~77 months
measure: Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan)
timeFrame: Up to ~57 months
measure: Objective Response Rate (ORR)
timeFrame: Up to ~57 months
measure: Duration of Response (DOR)
timeFrame: Up to ~57 months
measure: Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Baseline and up to ~77 months
measure: Change from baseline in physical functioning score, on the EORTC QLQ-C30
timeFrame: Baseline and up to ~77 months
measure: Change from baseline in emotional functioning score, on the EORTC QLQ-C30
timeFrame: Baseline and up to ~77 months
measure: Change from baseline in fatigue score, on the EORTC QLQ-C30
timeFrame: Baseline and up to ~77 months
measure: Change from baseline in diarrhea score, on the EORTC QLQ-C30
timeFrame: Baseline and up to ~77 months
measure: Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30
timeFrame: Up to ~77 months
measure: TTD in physical functioning score, on the EORTC QLQ-C30
timeFrame: Up to ~77 months
measure: TTD in emotional functioning score, on the EORTC QLQ-C30
timeFrame: Up to ~77 months
measure: TTD in fatigue score, on the EORTC QLQ-C30
timeFrame: Up to ~77 months
measure: TTD in diarrhea score, on the EORTC QLQ-C30
timeFrame: Up to ~77 months
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to ~77 months
measure: Number of participants who discontinue study treatment due to an AE
timeFrame: Up to ~77 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers ( Site 0066)
state: Arizona
city: Fullerton
country: United States
facility: Providence Medical Foundation-Oncology ( Site 0020)
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center ( Site 0059)
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic ( Site 0001)
state: California
city: New Haven
country: United States
facility: Yale Cancer Center ( Site 0060)
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital ( Site 0049)
state: Connecticut
city: Altamonte Springs
country: United States
facility: AdventHealth Altamonte Springs ( Site 0021)
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine ( Site 0063)
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute ( Site 0011)
state: Florida
city: Thomasville
country: United States
facility: Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center ( Site 0067)
state: Illinois
city: Edgewood
country: United States
facility: Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)
state: Louisiana
city: Baltimore
country: United States
facility: Greenebaum Comprehensive Cancer Center ( Site 0036)
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine ( Site 0076)
state: Missouri
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland ( Site 0054)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University-Cancer Center ( Site 0034)
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center ( Site 0044)
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center ( Site 0081)
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Clinical Research Institute ( Site 0056)
state: Pennsylvania
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders ( Site 0041)
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0025)
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)
state: Virginia
city: Richmond
country: United States
facility: VCU Health Adult Outpatient Pavillion ( Site 0070)
state: Virginia
city: Madison
country: United States
facility: University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)
state: Wisconsin
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming-Alexander Fleming ( Site 0382)
state: Caba
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos-Oncology ( Site 0384)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Aleman-Oncology ( Site 0386)
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0383)
city: Cordoba
country: Argentina
facility: Hospital Italiano de Córdoba ( Site 0385)
city: La Rioja
country: Argentina
facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387)
city: Macquarie University
country: Australia
facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 2002)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 2000)
state: New South Wales
city: Frankston
country: Australia
facility: Frankston Hospital-Oncology and Haematology ( Site 2003)
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital-Medical Oncology ( Site 2004)
state: Western Australia
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet-Medicine Oncology ( Site 1104)
state: Bruxelles-Capitale, Region De
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1103)
state: Bruxelles-Capitale, Region De
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105)
state: Limburg
city: Gent
country: Belgium
facility: AZ Maria Middelares-IKG ( Site 1106)
state: Oost-Vlaanderen
city: Namur
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1107)
city: Teresina
country: Brazil
facility: Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407)
state: Piaui
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento ( Site 0403)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital do Câncer Mãe de Deus ( Site 0404)
state: Rio Grande Do Sul
city: Santa Cruz do Sul
country: Brazil
facility: Instituto de Oncologia Saint Gallen ( Site 0412)
state: Rio Grande Do Sul
city: Taubaté
country: Brazil
facility: Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: IBCC - Núcleo de Pesquisa e Ensino ( Site 0401)
city: Surrey
country: Canada
facility: BC Cancer Surrey ( Site 0315)
state: British Columbia
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre ( Site 0311)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0310)
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0303)
state: Quebec
city: Rimouski
country: Canada
facility: Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0308)
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302)
city: Santiago.
country: Chile
facility: Oncovida ( Site 0453)
state: Region M. De Santiago
city: Santiago.
country: Chile
facility: Clínica RedSalud Vitacura ( Site 0455)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0451)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0454)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0452)
state: Region M. De Santiago
city: Antofagasta
country: Chile
facility: Bradford Hill Norte ( Site 0456)
city: Medellín
country: Colombia
facility: Fundacion Colombiana de Cancerología Clinica Vida ( Site 0506)
state: Antioquia
city: Valledupar
country: Colombia
facility: Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)
state: Cesar
city: Monteria.
country: Colombia
facility: IMAT S.A.S ( Site 0502)
state: Cordoba
city: Bogota
country: Colombia
facility: FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0507)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0508)
state: Valle Del Cauca
city: San José
country: Costa Rica
facility: CIMCA ( Site 0551)
state: San Jose
city: Santa Ana
country: Costa Rica
facility: Hospital Metropolitano - Sede Lindora ( Site 0550)
state: San Jose
city: San Jose
country: Costa Rica
facility: ICIMED ( Site 0552)
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1138)
state: Jihocesky Kraj
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1132)
state: Olomoucky Kraj
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1136)
state: Praha 5
city: Copenhagen
country: Denmark
facility: Rigshospitalet ( Site 1180)
state: Hovedstaden
city: Hillerod
country: Denmark
facility: Nordsjællands Hospital - Hillerød ( Site 1184)
state: Hovedstaden
city: Naestved
country: Denmark
facility: Næstved Sygehus ( Site 1182)
state: Sjaelland
city: Odense C
country: Denmark
facility: Odense Universitetshospital ( Site 1181)
state: Syddanmark
city: Vejle
country: Denmark
facility: Vejle Sygehus ( Site 1183)
state: Syddanmark
city: Caen
country: France
facility: Centre François Baclesse ( Site 1250)
state: Calvados
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier ( Site 1244)
state: Languedoc-Roussillon
city: Nantes
country: France
facility: Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242)
state: Loire-Atlantique
city: Paris
country: France
facility: Pitie Salpetriere University Hospital ( Site 1249)
state: Orne
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz-Oncology ( Site 1246)
state: Rhone-Alpes
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1243)
state: Vienne
city: Paris
country: France
facility: Institut Curie-Oncology medical Department ( Site 1240)
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center ( Site 1348)
state: Attiki
city: Athens
country: Greece
facility: Aretaieio Hospital Oncology Unit ( Site 1345)
state: Attiki
city: Marousi
country: Greece
facility: Hygeia Hospital ( Site 1346)
state: Attiki
city: Thessaloniki
country: Greece
facility: Agios Loukas Clinic ( Site 1347)
state: Kentriki Makedonia
city: Larissa
country: Greece
facility: University General Hospital of Larissa ( Site 1343)
state: Thessalia
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center ( Site 1341)
city: Hksar
country: Hong Kong
facility: Queen Mary Hospital ( Site 2040)
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 2041)
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterápiás Klinika ( Site 1379)
state: Csongrad
city: Kaposvár
country: Hungary
facility: Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1371)
state: Somogy
city: Zalaegerszeg
country: Hungary
facility: Zala Vármegyei Szent Rafael Kórház-Onkológiai osztály ( Site 1372)
state: Zala
city: Budapest
country: Hungary
facility: Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1373)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1375)
city: New Delhi
country: India
facility: All India Institute of Medical Sciences ( Site 2051)
state: Delhi
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre-Department of Clinical Research ( Site 2052)
state: Delhi
city: Mumbai
country: India
facility: Tata Memorial Hospital-Medical Oncology ( Site 2053)
state: Maharashtra
city: Mumbai
country: India
facility: Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 2056)
state: Maharashtra
city: Cork
country: Ireland
facility: Bon Secours Cork Hospital ( Site 1422)
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1420)
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital-Clinical Trials Research Unit ( Site 1423)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 1452)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1451)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1453)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 1450)
city: Meldola
country: Italy
facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1480)
state: Forli-Cesena
city: Aviano
country: Italy
facility: CRO-IRCCS ( Site 1478)
state: Friuli-Venezia Giulia
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1475)
state: Lombardia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1472)
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas ( Site 1476)
state: Milano
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474)
city: Genova
country: Italy
facility: Ospedale San Martino ( Site 1479)
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 1471)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1477)
city: Nagoya
country: Japan
facility: Nagoya City University Hospital ( Site 2474)
state: Aichi
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 2460)
state: Hokkaido
city: Isehara
country: Japan
facility: Tokai University Hospital ( Site 2473)
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 2465)
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital ( Site 2471)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 2472)
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital ( Site 2483)
state: Mie
city: Sendai
country: Japan
facility: Tohoku University Hospital ( Site 2482)
state: Miyagi
city: Suita
country: Japan
facility: The University of Osaka Hospital ( Site 2476)
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 2462)
state: Saitama
city: Bunkyo
country: Japan
facility: Juntendo University Hospital ( Site 2468)
state: Tokyo
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 2464)
state: Tokyo
city: Shinagawa
country: Japan
facility: Showa Medical University Hospital ( Site 2466)
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital ( Site 2467)
state: Tokyo
city: Shinjuku
country: Japan
facility: National Center for Global Health and Medicine ( Site 2469)
state: Tokyo
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 2461)
city: Gifu
country: Japan
facility: Gifu University Hospital ( Site 2486)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2478)
city: Kagoshima
country: Japan
facility: Social medical corporation Hakuaikai Sagara Hospital ( Site 2481)
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital ( Site 2480)
city: Kyoto
country: Japan
facility: Kyoto University Hospital ( Site 2475)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 2485)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 2477)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital-Internal Medicine ( Site 2353)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 2350)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Department of Oncology ( Site 2352)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 2351)
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail ( Site 2153)
state: Johor
city: Kuching
country: Malaysia
facility: Sarawak General Hospital ( Site 2154)
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur ( Site 2151)
city: Ciudad de México
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V: ( Site 0598)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Grupo Médico ASSET-Clinical Research ( Site 0596)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: CIO - Centro de Inmuno-Oncología de Occidente ( Site 0592)
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0590)
state: Nuevo Leon
city: San Pedro Garza Garcia
country: Mexico
facility: CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 0595)
state: Nuevo Leon
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 1524)
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+-Medical Oncology ( Site 1522)
state: Limburg
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis, locatie Breda Molengracht-oncologie ( Site 1523)
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis ( Site 1526)
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1520)
state: Noord-Holland
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle ( Site 1525)
state: Overijssel
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum ( Site 1521)
state: Utrecht
city: Auckland
country: New Zealand
facility: Auckland City Hospital ( Site 2031)
city: Arequipa
country: Peru
facility: Clinica Vallesur - AUNA ( Site 0652)
state: Ariqipa
city: Jesús María
country: Peru
facility: Hospital Militar Central Luis Arias Schereiber ( Site 0651)
state: Lima
city: Lima
country: Peru
facility: Oncosalud ( Site 0650)
state: Muni Metro De Lima
city: Lima
country: Peru
facility: IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0653)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1582)
state: Kujawsko-pomorskie
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1584)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 1580)
state: Mazowieckie
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny ( Site 1581)
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Mrukmed-Mrukmed ( Site 1592)
state: Podkarpackie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii ( Site 1585)
state: Podlaskie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 1593)
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 1590)
state: Slaskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1595)
state: Swietokrzyskie
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1583)
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii ( Site 1588)
state: Zachodniopomorskie
city: Lisbon
country: Portugal
facility: Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 1663)
state: Lisboa
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1661)
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1662)
city: Hato Rey
country: Puerto Rico
facility: Puerto Rico Medical Research Center LLC ( Site 0675)
city: San Juan
country: Puerto Rico
facility: UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677)
city: București
country: Romania
facility: Spitalul Clinic Filantropia ( Site 1703)
state: Bucuresti
city: Florești
country: Romania
facility: SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1702)
state: Cluj
city: Bucuresti
country: Romania
facility: Centrul Medical Neolife- Baneasa ( Site 1704)
city: Cluj
country: Romania
facility: Institutul Oncologic Cluj ( Site 1701)
city: Singapore
country: Singapore
facility: National University Hospital ( Site 2250)
state: Central Singapore
city: Singapore
country: Singapore
facility: Mount Alvernia ICON Cancer Center ( Site 2251)
state: North East
city: Port Elizabeth
country: South Africa
facility: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2905)
state: Eastern Cape
city: Pretoria
country: South Africa
facility: Curo Oncology ( Site 2908)
state: Gauteng
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group (Pty) Ltd ( Site 2911)
state: Gauteng
city: Rondebosch
country: South Africa
facility: Cancercare Rondebosch Oncology-Clinical trials ( Site 2904)
state: Western Cape
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1758)
state: Madrid
city: Valencia
country: Spain
facility: HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 1752)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Oncology ( Site 1750)
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia-Oncologia Medica ( Site 1754)
city: Madrid
country: Spain
facility: Hospital Beata María Ana-oncology ( Site 1755)
city: Madrid
country: Spain
facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 1756)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena ( Site 1757)
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1801)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset ( Site 1802)
state: Uppsala Lan
city: Borås
country: Sweden
facility: Södra Älvsborgs Sjukhus Borås ( Site 1803)
state: Vastra Gotalands Lan
city: Basel
country: Switzerland
facility: University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 1844)
state: Basel-Stadt
city: Thun
country: Switzerland
facility: Spital Thun ( Site 1840)
state: Berne
city: Zürich
country: Switzerland
facility: Brust-Zentrum ( Site 1841)
state: Zurich
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital ( Site 2410)
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2413)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Surgery ( Site 2411)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 2415)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 2412)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch-General Surgery ( Site 2414)
city: Stanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi-oncology ( Site 1875)
state: Istanbul
city: Adana
country: Turkey
facility: Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1876)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 1870)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 1874)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1871)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1872)
city: Samsun
country: Turkey
facility: Samsun Medical Park Hastanesi-medical oncology ( Site 1873)
city: Londonderry
country: United Kingdom
facility: North West Cancer Centre ( Site 1944)
state: Derry And Strabane
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital ( Site 1943)
state: England
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)
state: London, City Of
city: London
country: United Kingdom
facility: University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)
state: London, City Of
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital ( Site 1941)
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: