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Trial Title: 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)

NCT ID: NCT06312176

Condition: Breast Neoplasms

Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Pembrolizumab
Doxorubicin
Liposomal doxorubicin
Capecitabine

Conditions: 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)

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Sacituzumab tirumotecan
Description: IV infusion
Arm group label: Arm A: Sacituzumab tirumotecan
Arm group label: Arm B:Pembrolizumab + Sacituzumab tirumotecan

Other name: MK-2870

Intervention type: Biological
Intervention name: Pembrolizumab
Description: IV infusion
Arm group label: Arm B:Pembrolizumab + Sacituzumab tirumotecan

Other name: MK-3475

Other name: KEYTRUDA®

Intervention type: Drug
Intervention name: Paclitaxel
Description: IV infusion
Arm group label: Arm C: Treatment of Physician's Choice (TPC)

Other name: TAXOL®

Intervention type: Drug
Intervention name: Nab-paclitaxel
Description: IV infusion
Arm group label: Arm C: Treatment of Physician's Choice (TPC)

Other name: ABRAXANE®

Intervention type: Drug
Intervention name: Capecitabine
Description: oral tablet
Arm group label: Arm C: Treatment of Physician's Choice (TPC)

Other name: XELODA®

Intervention type: Drug
Intervention name: Liposomal doxorubicin
Description: IV infusion
Arm group label: Arm C: Treatment of Physician's Choice (TPC)

Other name: DOXIL®

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Providence Medical Foundation-Oncology ( Site 0020)

Address:
City: Fullerton
Zip: 92835
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 714-446-5900

Facility:
Name: AdventHealth Altamonte Springs ( Site 0021)

Address:
City: Altamonte Springs
Zip: 32701
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 407-834-5151

Facility:
Name: Orlando Health Cancer Institute ( Site 0011)

Address:
City: Orlando
Zip: 32806
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 321-841-4309

Facility:
Name: Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)

Address:
City: Thomasville
Zip: 31792
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 229-584-5400

Facility:
Name: Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)

Address:
City: Baton Rouge
Zip: 70817
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 225-767-1311

Facility:
Name: Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)

Address:
City: Baltimore
Zip: 21202
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 410-783-5858

Facility:
Name: Hematology Oncology Associates of Rockland ( Site 0054)

Address:
City: Nyack
Zip: 10960
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 845-480-7440

Facility:
Name: Stony Brook University-Cancer Center ( Site 0034)

Address:
City: Stony Brook
Zip: 11794
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 520-349-1302

Facility:
Name: Providence Portland Medical Center ( Site 0044)

Address:
City: Portland
Zip: 97213
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 503-215-5401

Facility:
Name: Providence St. Vincent Medical Center ( Site 0081)

Address:
City: Portland
Zip: 97225
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 503-215-5401

Facility:
Name: The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center (

Address:
City: Tyler
Zip: 75701
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 903-595-7093

Facility:
Name: Instituto Alexander Fleming-Alexander Fleming ( Site 0382)

Address:
City: Ciudad Autónoma de Buenos Aires
Zip: 1426
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +5491138850425

Facility:
Name: Fundacion Estudios Clinicos-Oncology ( Site 0384)

Address:
City: Rosario
Zip: S2000DEJ
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +5493469699922

Facility:
Name: Hospital Aleman-Oncology ( Site 0386)

Address:
City: Buenos Aires
Zip: C1118AAT
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 541148277000x2306

Facility:
Name: Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0383)

Address:
City: Buenos Aires
Zip: C1431FWO
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5491140375232

Facility:
Name: Hospital Italiano de Córdoba ( Site 0385)

Address:
City: Cordoba
Zip: X5004BAL
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 3515054293

Facility:
Name: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387)

Address:
City: La Rioja
Zip: F5300COE
Country: Argentina

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 543804436443 ext. 108

Facility:
Name: Macquarie University-MQ Health Clinical Trials Unit ( Site 2002)

Address:
City: Macquarie University
Zip: 2109
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 98122973

Facility:
Name: Westmead Hospital-Westmead Breast Cancer Institute ( Site 2000)

Address:
City: Westmead
Zip: 2145
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0405465494

Facility:
Name: Frankston Hospital-Oncology and Haematology ( Site 2003)

Address:
City: Frankston
Zip: 3199
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 61397856344

Facility:
Name: Fiona Stanley Hospital-Medical Oncology ( Site 2004)

Address:
City: Murdoch
Zip: 6150
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: + 61 8 6152 4004

Facility:
Name: Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407)

Address:
City: Teresina
Zip: 64049-200
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 55 86 999007799

Facility:
Name: Hospital Moinhos de Vento ( Site 0403)

Address:
City: Porto Alegre
Zip: 90035-001
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 555133143693

Facility:
Name: Hospital do Câncer Mãe de Deus ( Site 0404)

Address:
City: Porto Alegre
Zip: 90110-270
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5132344345

Facility:
Name: Instituto de Oncologia Saint Gallen ( Site 0412)

Address:
City: Santa Cruz do Sul
Zip: 96830-180
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5551991898942

Facility:
Name: Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408)

Address:
City: Taubaté
Zip: 12030-200
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +55 12 996706805

Facility:
Name: IBCC - Núcleo de Pesquisa e Ensino ( Site 0401)

Address:
City: Sao Paulo
Zip: 04014-002
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5511984680001

Facility:
Name: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301)

Address:
City: Montreal
Zip: H1T 2M4
Country: Canada

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 514 252-3400 EXT 5853

Facility:
Name: FALP-UIDO ( Site 0451)

Address:
City: Santiago
Zip: 7500921
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +56990101775

Facility:
Name: Oncovida ( Site 0453)

Address:
City: Santiago
Zip: 7510032
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5624205100

Facility:
Name: Clínica RedSalud Vitacura ( Site 0455)

Address:
City: Santiago
Zip: 7650018
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56982926243

Facility:
Name: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0454)

Address:
City: Santiago
Zip: 8330032
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56223546919

Facility:
Name: Bradfordhill ( Site 0452)

Address:
City: Santiago
Zip: 8420383
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +56978878489

Facility:
Name: Bradford Hill Norte ( Site 0456)

Address:
City: Antofagasta
Zip: 1263521
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56994198125

Facility:
Name: Fundacion Colombiana de Cancerología Clinica Vida ( Site 0506)

Address:
City: Medellín
Zip: 050030
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 573147362301

Facility:
Name: Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)

Address:
City: Valledupar
Zip: 200001
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 57 3175150103

Facility:
Name: Oncomédica S.A.S ( Site 0502)

Address:
City: Monteria
Zip: 230002
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +57 3205669416

Facility:
Name: FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Sit

Address:
City: Bogota
Zip: 110131
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 3174236866

Facility:
Name: Fundación Valle del Lili ( Site 0508)

Address:
City: Cali
Zip: 760032
Country: Colombia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5723319090

Facility:
Name: CIMCA ( Site 0551)

Address:
City: San José
Zip: 10103
Country: Costa Rica

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 50683893636

Facility:
Name: Hospital Metropolitano - Sede Lindora ( Site 0550)

Address:
City: Santa Ana
Zip: 10903
Country: Costa Rica

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 50684978912

Facility:
Name: ICIMED ( Site 0552)

Address:
City: San Jose
Zip: 10108
Country: Costa Rica

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 506 88317449

Facility:
Name: Centre de Cancérologie du Grand Montpellier ( Site 1244)

Address:
City: Montpellier
Zip: 34070
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 33467926155

Facility:
Name: Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242)

Address:
City: Nantes
Zip: 44277
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 33228272088

Facility:
Name: Pitie Salpetriere University Hospital ( Site 1249)

Address:
City: Paris
Zip: 75013
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +33142160097

Facility:
Name: Hopital Prive Jean Mermoz-Oncology ( Site 1246)

Address:
City: Lyon
Zip: 69008
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0659321781

Facility:
Name: Institut Curie-Oncology medical Department ( Site 1240)

Address:
City: Paris
Zip: 75248
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 33144324675

Facility:
Name: Errikos Dunant Hospital Center ( Site 1348)

Address:
City: Athens
Zip: 115 26
Country: Greece

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +306981001801

Facility:
Name: Agios Loukas Clinic ( Site 1347)

Address:
City: Thessaloniki
Zip: 552 36
Country: Greece

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 6974000528

Facility:
Name: University General Hospital of Larissa ( Site 1343)

Address:
City: Larissa
Zip: 411 10
Country: Greece

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 00302413502027

Facility:
Name: Queen Mary Hospital ( Site 2040)

Address:
City: Hksar
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +852 39103299

Facility:
Name: Prince of Wales Hospital ( Site 2041)

Address:
City: Shatin
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 85235051042

Facility:
Name: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterápiás Klinika ( Site 1379)

Address:
City: Szeged
Zip: 6720
Country: Hungary

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 003662545404

Facility:
Name: Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1371)

Address:
City: Kaposvár
Zip: 7400
Country: Hungary

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +3682501300 1445

Facility:
Name: Zala Vármegyei Szent Rafael Kórház-Onkológiai osztály ( Site 1372)

Address:
City: Zalaegerszeg
Zip: 8900
Country: Hungary

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 36304199969

Facility:
Name: Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1373)

Address:
City: Budapest
Zip: 1145
Country: Hungary

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 36203231895

Facility:
Name: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1375)

Address:
City: Debrecen
Zip: 4032
Country: Hungary

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 3652255840

Facility:
Name: Rambam Health Care Campus-Oncology Division ( Site 1452)

Address:
City: Haifa
Zip: 3109601
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 972-4-777-6700

Facility:
Name: Hadassah Medical Center ( Site 1451)

Address:
City: Jerusalem
Zip: 9112001
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 972542626027

Facility:
Name: Rabin Medical Center ( Site 1453)

Address:
City: Petah Tikva
Zip: 4941492
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 972504065625

Facility:
Name: Sheba Medical Center ( Site 1450)

Address:
City: Ramat Gan
Zip: 5265601
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 972543212828

Facility:
Name: CRO-IRCCS ( Site 1478)

Address:
City: Aviano
Zip: 33081
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +39 0434659514

Facility:
Name: Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1475)

Address:
City: Milano
Zip: 20141
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 390257489970

Facility:
Name: Istituto Clinico Humanitas ( Site 1476)

Address:
City: Rozzano
Zip: 20089
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 390282244080

Facility:
Name: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474)

Address:
City: Bologna
Zip: 40138
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +39 0512144548

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (

Address:
City: Roma
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 390294379280

Facility:
Name: Seoul National University Hospital-Internal Medicine ( Site 2353)

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 02-2072-0850

Facility:
Name: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 2350)

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82222288135

Facility:
Name: Asan Medical Center-Department of Oncology ( Site 2352)

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82230103216

Facility:
Name: Samsung Medical Center-Division of Hematology/Oncology ( Site 2351)

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 821099331780

Facility:
Name: Hospital Sultan Ismail ( Site 2153)

Address:
City: Johor Bahru
Zip: 81100
Country: Malaysia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 60107661015

Facility:
Name: Sarawak General Hospital ( Site 2154)

Address:
City: Kuching
Zip: 93586
Country: Malaysia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 082-276666

Facility:
Name: Pantai Hospital Kuala Lumpur ( Site 2151)

Address:
City: Kuala Lumpur
Zip: 59100
Country: Malaysia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 60322960800

Facility:
Name: Health Pharma Professional Research S.A. de C.V: ( Site 0598)

Address:
City: Ciudad de México
Zip: 03100
Country: Mexico

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5514817472

Facility:
Name: Grupo Médico ASSET-Clinical Research ( Site 0596)

Address:
City: Mexico City
Zip: 03100
Country: Mexico

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +525551013316

Facility:
Name: CIO - Centro de Inmuno-Oncología de Occidente ( Site 0592)

Address:
City: Guadalajara
Zip: 44630
Country: Mexico

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 3331721132

Facility:
Name: Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 1524)

Address:
City: Arnhem
Zip: 6815 AD
Country: Netherlands

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +31880056201

Facility:
Name: Amphia Ziekenhuis, locatie Breda Molengracht-oncologie ( Site 1523)

Address:
City: Breda
Zip: 4800 RK
Country: Netherlands

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +31 (0)765951564

Facility:
Name: Catharina Ziekenhuis ( Site 1526)

Address:
City: Eindhoven
Zip: 5623 EJ
Country: Netherlands

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 31402396622

Facility:
Name: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1520)

Address:
City: Amsterdam
Zip: 1066 CX
Country: Netherlands

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 31205127901

Facility:
Name: Meander Medisch Centrum ( Site 1521)

Address:
City: Amersfoort
Zip: 3813TZ
Country: Netherlands

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 31338505050

Facility:
Name: Auckland City Hospital-Cancer & Blood Research ( Site 2031)

Address:
City: Auckland
Zip: 1023
Country: New Zealand

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 272044842

Facility:
Name: Clinica Vallesur - AUNA ( Site 0652)

Address:
City: Arequipa
Zip: 04001
Country: Peru

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 959665164

Facility:
Name: Hospital Militar Central Luis Arias Schereiber ( Site 0651)

Address:
City: Jesús María
Zip: 18
Country: Peru

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 51997468543

Facility:
Name: Oncosalud ( Site 0650)

Address:
City: Lima
Zip: 15036
Country: Peru

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 51999389433

Facility:
Name: IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0653)

Address:
City: Lima
Zip: 15036
Country: Peru

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 956754968

Facility:
Name: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1582)

Address:
City: Bydgoszcz
Zip: 85-796
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +48523743525

Facility:
Name: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1584)

Address:
City: Siedlce
Zip: 08-110
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48698826497

Facility:
Name: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii (

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48225462522

Facility:
Name: Mazowiecki Szpital Onkologiczny ( Site 1581)

Address:
City: Wieliszew
Zip: 05-135
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +48227661500 ext. 134

Facility:
Name: Mrukmed-Mrukmed ( Site 1592)

Address:
City: Rzeszow
Zip: 35-021
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48178502470

Facility:
Name: Bialostockie Centrum Onkologii ( Site 1585)

Address:
City: Bialystok
Zip: 15-027
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48856646760

Facility:
Name: Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 1593)

Address:
City: Gdynia
Zip: 81-519
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0048587260964

Facility:
Name: Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Sit

Address:
City: Gliwice
Zip: 44-102
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48662230234

Facility:
Name: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch

Address:
City: Kielce
Zip: 25-734
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48 413674807

Facility:
Name: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1583)

Address:
City: Koszalin
Zip: 75-581
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0048943488937

Facility:
Name: Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 1663)

Address:
City: Lisbon
Zip: 2720-276
Country: Portugal

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +351966722731

Facility:
Name: Puerto Rico Medical Research Center LLC ( Site 0675)

Address:
City: Hato Rey
Zip: 00917
Country: Puerto Rico

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 7872968394

Facility:
Name: UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677)

Address:
City: San Juan
Zip: 00935
Country: Puerto Rico

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 7879361477

Facility:
Name: Spitalul Clinic Filantropia ( Site 1703)

Address:
City: București
Zip: 011171
Country: Romania

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 40744874350

Facility:
Name: SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1702)

Address:
City: Florești
Zip: 407280
Country: Romania

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 40742206212

Facility:
Name: Centrul Medical Neolife- Baneasa ( Site 1704)

Address:
City: Bucuresti
Zip: 077190
Country: Romania

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0040722927377

Facility:
Name: Institutul Oncologic Cluj ( Site 1701)

Address:
City: Cluj
Zip: 400015
Country: Romania

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 40740226786

Facility:
Name: National University Hospital ( Site 2250)

Address:
City: Singapore
Zip: 119074
Country: Singapore

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +6569082222

Facility:
Name: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1758)

Address:
City: Pozuelo de Alarcon
Zip: 28223
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 3491452198

Facility:
Name: HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 1752)

Address:
City: Valencia
Zip: 46010
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34961973583

Facility:
Name: Hospital Universitari Vall d'Hebron-Oncology ( Site 1750)

Address:
City: Barcelona
Zip: 08035
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0034932746000 (ext. 4350)

Facility:
Name: Hospital Universitario Reina Sofia-Oncologia Medica ( Site 1754)

Address:
City: Cordoba
Zip: 14004
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34957012408

Facility:
Name: Hospital Beata María Ana-oncology ( Site 1755)

Address:
City: Madrid
Zip: 28007
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: (+34)913368263

Facility:
Name: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 1756)

Address:
City: Madrid
Zip: 28009
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34657145458

Facility:
Name: Hospital Universitario Virgen Macarena ( Site 1757)

Address:
City: Sevilla
Zip: 41009
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34600162731

Facility:
Name: University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 1844)

Address:
City: Basel
Zip: 4031
Country: Switzerland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +41 61 328 73 31

Facility:
Name: Spital Thun ( Site 1840)

Address:
City: Thun
Zip: 3600
Country: Switzerland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +41586362645

Facility:
Name: Brust-Zentrum ( Site 1841)

Address:
City: Zürich
Zip: 8008
Country: Switzerland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +41794580632

Facility:
Name: Changhua Christian Hospital (Site # 2410)

Address:
City: Changhua County
Zip: 50006
Country: Taiwan

Status: Recruiting

Contact:
Last name: Shou-Tung Chen

Facility:
Name: Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology (Site # 2413)

Address:
City: Kaohsiung
Zip: 83301
Country: Taiwan

Status: Recruiting

Contact:
Last name: Chien-Ting Liu

Phone: 88677317123 x3267

Facility:
Name: National Cheng Kung University Hospital-Surgery (Site # 2411)

Address:
City: Tainan
Zip: 704
Country: Taiwan

Status: Recruiting

Contact:
Last name: Kuo-Ting Lee

Phone: 886623535354273

Facility:
Name: National Taiwan University Hospital-Oncology (Site # 2415)

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Status: Recruiting

Contact:
Last name: Yen-Shen Lu

Phone: 886223123456700900

Facility:
Name: Mackay Memorial Hospital (Site # 2412)

Address:
City: Taipei
Zip: 10449
Country: Taiwan

Status: Recruiting

Contact:
Last name: Yuan-Ching Chang

Phone: +886225433535

Facility:
Name: Chang Gung Medical Foundation-Linkou Branch-General Surgery (Site # 2414)

Address:
City: Taoyuan
Zip: 333
Country: Taiwan

Status: Recruiting

Contact:
Last name: Shin-Cheh Chen

Phone: 886332812003605

Facility:
Name: The Royal Cornwall Hospital ( Site 1943)

Address:
City: Truro
Zip: TR1 3LJ
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 441872258307

Facility:
Name: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)

Address:
City: London
Zip: EC1A 7BE
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 442078828498

Facility:
Name: City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)

Address:
City: Nottingham
Zip: NG5 1PB
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 44115969116954265

Start date: April 14, 2024

Completion date: April 12, 2031

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06312176
https://www.merckclinicaltrials.com/
https://msd.trialsummaries.com/Study/StudyDetails?id=26170&tenant=MT_MSD_9011

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