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