Trial Title:
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
NCT ID:
NCT06393374
Condition:
Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Pembrolizumab
Capecitabine
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:
Biological
Intervention name:
Pembrolizumab
Description:
Pembrolizumab 400 mg intravenous (IV) infusion q6w
Arm group label:
Pembrolizumab + sac-TMT
Arm group label:
Treatment of Physician's Choice
Other name:
KEYTRUDA®
Other name:
MK-3475
Other name:
SCH 900475
Intervention type:
Biological
Intervention name:
sac-TMT
Description:
sac-TMT 4 mg/kg IV infusion q2w
Arm group label:
Pembrolizumab + sac-TMT
Other name:
MK-2870
Other name:
Sacituzumab tirumotecan
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine 1000 mg/m^2 to 1250 mg/m^2 by mouth BID
Arm group label:
Treatment of Physician's Choice
Other name:
XELODA
Summary:
This is a randomized, open-label study comparing the efficacy and safety of adjuvant
sacituzumab tirumotecan (sac-TMT; MK-2870) in combination with pembrolizumab compared to
treatment of physician's choice (TPC) in participants with triple-negative breast cancer
(TNBC) who received neoadjuvant therapy and did not achieve a pathological complete
response (pCR) at surgery. The primary objective is to compare sac-TMT plus pembrolizumab
to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive
disease-free survival (iDFS) per investigator assessment. It is hypothesized that sac-TMT
plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has centrally confirmed TNBC, as defined by the most recent American Society of
Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Has no evidence of locoregional or distant relapse, as assessed by the treating
physician
- Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with
carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy)
followed by surgery according to National Comprehensive Cancer Network (NCCN)
treatment guidelines for TNBC
- Had adequate excision and surgical removal of all clinically evident disease in the
breast and/or lymph nodes and have adequately recovered from surgery
- Has non-pathologic complete response at surgery
- Is able to continue on adjuvant pembrolizumab
- Randomization must be conducted within 12 weeks from surgical resection
- Completed adjuvant radiation therapy (if indicated) and recovered before
randomization
- Has provided tissue from the surgical resection for central laboratory determination
of trophoblast cell surface antigen 2 (TROP2) status
- If capable of producing sperm, the participant agrees to the following during the
intervention period and for at least the time needed to eliminate each study
intervention after the last dose of study intervention (100 days for MK-2870 and 95
days for capecitabine [no restriction for pembrolizumab]) AND agrees to refrain from
donating sperm AND is either abstinent and agrees to remain abstinent or uses highly
effective contraception
- For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the
following applies: is not a participant of childbearing potential (POCBP) OR is a
POCBP and uses highly effective contraction after the last dose of study
intervention (190 days for MK-2870, 120 days for pembrolizumab, and 185 days for
capecitabine). Abstains from breastfeeding during the study intervention period and
for at least 120 days after study intervention
- Participants who have AEs due to previous anticancer therapies must have recovered
to ≤Grade 1 or baseline (except alopecia)
- Human immunodeficiency virus (HIV)-infected participants must have well controlled
HIV on Antiretroviral Therapy (ART)
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed
within 7 days before first dose of study treatment
- Participants who are Hepatitis B Surface Antigen (HBsAg) positive are eligible if
they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks,
and have undetectable HBV viral load prior to randomization
Exclusion Criteria:
- Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected
deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is
approved and available
- Has Grade >2 peripheral neuropathy
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or
blepharitis, or corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or
previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
including New York Heart Association Class III or IV congestive heart failure,
unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia,
prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and
cerebrovascular diseases within 6 months prior to study intervention
- Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed
antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC
- Received anticancer therapy in the adjuvant phase including but not limited to
chemotherapy, small molecule anticancer drugs, Poly (ADP ribose) Polymerase (PARP)
inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation
therapy
- Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4)
that cannot be discontinued for the duration of the study. The required washout
period before starting MK-2870 is 2 weeks
- Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior
therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed
cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to
another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
- Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior
systemic anticancer therapy including investigational agents within 4 weeks before
randomization
- Received prior radiotherapy within 3 weeks of start of study intervention or
required corticosteroids for radiation related toxicities that cannot be
discontinued before the first dose of study intervention
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines are allowed
- Has received an investigational agent or has used an investigational device within 4
weeks prior to study intervention administration
- Has known additional malignancy that is progressing or has required active treatment
within the past 5 years
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study medication
- Has active autoimmune disease that has required systemic treatment in the past 2
years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
is allowed
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric
Castleman's Disease
- Has concurrent active hepatitis B and hepatitis C virus infection
- Has history of allogeneic tissue/solid organ transplant
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Infirmary Cancer Care ( Site 0001)
Address:
City:
Mobile
Zip:
36607
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
251-435-2273
Facility:
Name:
Ironwood Cancer & Research Centers-Research ( Site 0054)
Address:
City:
Chandler
Zip:
85224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
480-821-2838
Facility:
Name:
Cancer Blood and Specialty Clinic-Research ( Site 0008)
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
562-706-6648
Facility:
Name:
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)
Address:
City:
Thomasville
Zip:
31792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
229-584-5400
Facility:
Name:
Orchard Healthcare Research Inc. ( Site 0014)
Address:
City:
Skokie
Zip:
60077
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
224-534-7580
Facility:
Name:
Parkview Research Center at Parkview Regional Medical Center ( Site 0011)
Address:
City:
Fort Wayne
Zip:
46845
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
260-266-7100
Facility:
Name:
Cancer Center of Kansas ( Site 0004)
Address:
City:
Wichita
Zip:
67214
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
316-262-4467
Facility:
Name:
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)
Address:
City:
Monroe
Zip:
71202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
318-813-1410
Facility:
Name:
Louisiana State University Health Sciences Shreveport ( Site 0029)
Address:
City:
Shreveport
Zip:
71103
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
318-813-1410
Facility:
Name:
Lake Regional Hospital ( Site 0009)
Address:
City:
Osage Beach
Zip:
65065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
573-302-2772
Facility:
Name:
Genesis Healthcare System ( Site 0025)
Address:
City:
Zanesville
Zip:
43701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
740-454-5271
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:
Virginia Cancer Institute ( Site 0034)
Address:
City:
Richmond
Zip:
23229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
804-287-3000
Facility:
Name:
Hospital Británico de Buenos Aires-Oncology ( Site 0502)
Address:
City:
Ciudad autónoma de Buenos Aires
Zip:
C1280AEB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
54911563819972
Facility:
Name:
Instituto Alexander Fleming-Alexander Fleming ( Site 0509)
Address:
City:
Ciudad Autónoma de Buenos Aires
Zip:
1426
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5491138850425
Facility:
Name:
Sanatorio Parque ( Site 0512)
Address:
City:
Rosario
Zip:
S2000DSV
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
543414929663
Facility:
Name:
Hospital Aleman-Oncology ( Site 0501)
Address:
City:
Buenos Aires
Zip:
C1118AAT
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
541148277000x2306
Facility:
Name:
Sanatorio Finochietto ( Site 0513)
Address:
City:
Buenos Aires
Zip:
C1187AAN
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+54 113752-8000
Facility:
Name:
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508)
Address:
City:
Buenos Aires
Zip:
C1431FWO
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5491140375232
Facility:
Name:
Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)
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 2700)
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0405465494
Facility:
Name:
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Address:
City:
Brisbane
Zip:
4029
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61736468111
Facility:
Name:
Frankston Hospital-Oncology and Haematology ( Site 2704)
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61397856344
Facility:
Name:
Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0043 5 7255 25800
Facility:
Name:
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
3227645435
Facility:
Name:
AZ Maria Middelares-IKG ( Site 0903)
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
003292468464
Facility:
Name:
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)
Address:
City:
Namur
Zip:
5530
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
003281423858
Facility:
Name:
PRONUTRIR-CLINICAL RESEARCH ( Site 0609)
Address:
City:
Fortaleza
Zip:
60810-180
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5585999205458
Facility:
Name:
Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)
Address:
City:
Teresina
Zip:
64049200
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
55 86 999007799
Facility:
Name:
Hospital do Câncer Mãe de Deus ( Site 0604)
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 0614)
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 0608)
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 0601)
Address:
City:
Sao Paulo
Zip:
04014002
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5511984680001
Facility:
Name:
Jewish General Hospital ( Site 0416)
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
514-340-8222 24210
Facility:
Name:
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1005)
Address:
City:
Brno
Zip:
656 53
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
420543134000
Facility:
Name:
Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1007)
Address:
City:
Ceske Budejovice
Zip:
37001
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
387875001
Facility:
Name:
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
420588444295
Facility:
Name:
Vseobecna fakultni nemocnice v Praze-Onkologická klinika VFN ( Site 1002)
Address:
City:
Praha
Zip:
128 08
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+420 224 966 764 759 768
Facility:
Name:
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1000)
Address:
City:
Praha
Zip:
150 06
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
224434701
Facility:
Name:
Tampereen yliopistollinen sairaala ( Site 1102)
Address:
City:
Tampere
Zip:
33520
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+358331166764
Facility:
Name:
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1100)
Address:
City:
Helsinki
Zip:
00029
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+358947174900
Facility:
Name:
Turku University Hospital-Department of Oncology ( Site 1103)
Address:
City:
Turku
Zip:
20520
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+35823130721
Facility:
Name:
Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405)
Address:
City:
Ludwigsburg
Zip:
71640
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
004971419996433
Facility:
Name:
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401)
Address:
City:
Essen
Zip:
45136
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
020117433092
Facility:
Name:
CaritasKlinikum Saarbrücken St. Theresia ( Site 1410)
Address:
City:
Saarbrücken
Zip:
66113
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+496814061301
Facility:
Name:
Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413)
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+4930940113394
Facility:
Name:
Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508)
Address:
City:
Athens
Zip:
115 26
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+306981001801
Facility:
Name:
Agios Loukas Clinic ( Site 1507)
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 1503)
Address:
City:
Larissa
Zip:
411 10
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
00302413502027
Facility:
Name:
Euromedica General Clinic of Thessaloniki-Oncology Unit ( Site 1502)
Address:
City:
Thessaloniki
Zip:
546 45
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+306947330432
Facility:
Name:
Queen Mary Hospital ( Site 3600)
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+852 39103299
Facility:
Name:
Hadassah Medical Center ( Site 1700)
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
972542626027
Facility:
Name:
Rabin Medical Center ( Site 1702)
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97239378016
Facility:
Name:
Sheba Medical Center-ONCOLOGY ( Site 1701)
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
972-3-5304961
Facility:
Name:
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803)
Address:
City:
Naples
Zip:
80100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390817463660
Facility:
Name:
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+3908117770442
Facility:
Name:
Humanitas Istituto Clinico Catanese ( Site 1811)
Address:
City:
Misterbianco
Zip:
95045
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
09573390167
Facility:
Name:
CRO-IRCCS ( Site 1808)
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+39 0434659253
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+390630158545
Facility:
Name:
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812)
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390303996536
Facility:
Name:
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809)
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390257489970
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801)
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+39 0223902597
Facility:
Name:
Fondazione IRCCS San Gerardo dei Tintori ( Site 1813)
Address:
City:
Monza
Zip:
20900
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+39 0392339037
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi ( Site 1805)
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+390057947264
Facility:
Name:
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810)
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+39 0512144548
Facility:
Name:
Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804)
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
03213733822
Facility:
Name:
Seoul National University Hospital-Internal Medicine ( Site 3102)
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 3100)
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 3103)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82230103216
Facility:
Name:
Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Si
Address:
City:
Seoul
Zip:
06273
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
821087462662
Facility:
Name:
Samsung Medical Center-Division of Hematology/Oncology ( Site 3101)
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
821099331780
Facility:
Name:
Pantai Hospital Kuala Lumpur ( Site 2801)
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
60322960800
Facility:
Name:
Drammen Sykehus, Vestre Viken HF ( Site 2001)
Address:
City:
Drammen
Zip:
3004
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
4732803000
Facility:
Name:
Stavanger Universitetssykehus ( Site 2004)
Address:
City:
Stavanger
Zip:
4011
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+4741432221
Facility:
Name:
Oslo universitetssykehus, Radiumhospitalet ( Site 2002)
Address:
City:
Oslo
Zip:
0379
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+4747283445
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2102)
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48501446778
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-BREAST CANCER ( Site 2101)
Address:
City:
Wieliszew
Zip:
05-135
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+48227661500 ext. 134
Facility:
Name:
Bialostockie Centrum Onkologii ( Site 2105)
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 2113)
Address:
City:
Gdynia
Zip:
81-519
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+48 501220811
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:
Zachodniopomorskie Centrum Onkologii ( Site 2108)
Address:
City:
Szczecin
Zip:
71-730
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48914251502
Facility:
Name:
Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203)
Address:
City:
Amadora
Zip:
2720-276
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+351966722731
Facility:
Name:
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201)
Address:
City:
Lisbon
Zip:
1649-035
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+351 217 805 000
Facility:
Name:
Instituto Portugues de Oncologia do Porto ( Site 2202)
Address:
City:
Porto
Zip:
4200-072
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
961760869
Facility:
Name:
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304)
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34955015796
Facility:
Name:
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305)
Address:
City:
L Hospitalet De Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34932607744
Facility:
Name:
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307)
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34981178000
Facility:
Name:
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301)
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34913368263
Facility:
Name:
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308)
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34 9119 17358
Facility:
Name:
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303)
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34961104605
Facility:
Name:
Hospital Universitari Vall d'Hebron-Oncology ( Site 2300)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0034932746000 (ext. 4350)
Facility:
Name:
Hospital Beata María Ana-oncology ( Site 2309)
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34911175021
Facility:
Name:
Hospital Clinico San Carlos-Oncology Department ( Site 2306)
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34913303000
Facility:
Name:
HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302)
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34961973583
Facility:
Name:
Spital Thun ( Site 2400)
Address:
City:
Thun
Zip:
3600
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+41586362645
Facility:
Name:
Kantonsspital Graubünden-Medizin ( Site 2404)
Address:
City:
Chur
Zip:
7000
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
41812567568
Facility:
Name:
Brust-Zentrum ( Site 2401)
Address:
City:
Zürich
Zip:
8008
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+41794580632
Facility:
Name:
HFR Fribourg - Hôpital Cantonal ( Site 2402)
Address:
City:
Fribourg
Zip:
1708
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+41 26 30.22.60
Facility:
Name:
The Royal Cornwall Hospital ( Site 2603)
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 2602)
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
442078828498
Start date:
June 24, 2024
Completion date:
December 14, 2037
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/NCT06393374
https://www.merckclinicaltrials.com/
http://trialstransparency.merckclinicaltrials.com/Study.aspx?id=2870-012&kw=2870-012
