Clinical trial NCT06393374: Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Official title: A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Triple-Negative Breast Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 1530
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: This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (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 sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.


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 16 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 (120 days for sacituzumab tirumotecan and 95 days for capecitabine \[no restriction for pembrolizumab\]): 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 contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 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 birus (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 severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* 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 (adenosine diphosphate 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 sacituzumab tirumotecan 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, cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or 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

Primary outcomes:
measure: Invasive Disease-Free Survival (iDFS)
timeFrame: Up to ~77 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~101 months
measure: Distant recurrence-free survival (DRFS)
timeFrame: Up to ~101 months
measure: Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
timeFrame: Baseline and up to ~60 months
measure: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
timeFrame: Baseline and up to ~60 months
measure: Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
timeFrame: Baseline and up to ~60 months
measure: Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score
timeFrame: Baseline and up to ~60 months
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to ~42 weeks
measure: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Infirmary Cancer Care ( Site 0001)
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers-Research ( Site 0054)
state: Arizona
city: La Jolla
country: United States
facility: Scripps Cancer Center ( Site 0052)
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic ( Site 0008)
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland ( Site 0079)
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville ( Site 0081)
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco ( Site 0080)
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente - Santa Clara ( Site 0082)
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Vallejo Medical Center ( Site 0060)
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek ( Site 0078)
state: California
city: Walnut Creek
country: United States
facility: Bass Medical Group ( Site 0089)
state: California
city: New Haven
country: United States
facility: Yale Cancer Center ( Site 0053)
state: Connecticut
city: Saint Petersburg
country: United States
facility: Comprehensive Hematology Oncology ( Site 0091)
state: Florida
city: Thomasville
country: United States
facility: Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)
state: Georgia
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc. ( Site 0014)
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0011)
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas ( Site 0004)
state: Kansas
city: Monroe
country: United States
facility: Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Shreveport ( Site 0029)
state: Louisiana
city: Silver Spring
country: United States
facility: Holy Cross Hospital ( Site 0069)
state: Maryland
city: Royal Oak
country: United States
facility: Profound Research LLC ( Site 0074)
state: Michigan
city: Fenton
country: United States
facility: SSM Health Cancer Care - Fenton ( Site 0088)
state: Missouri
city: Osage Beach
country: United States
facility: Lake Regional Hospital ( Site 0009)
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)
state: New Mexico
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0067)
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance ( Site 0086)
state: New York
city: Bismarck
country: United States
facility: Sanford Cancer Center Bismarck ( Site 0058)
state: North Dakota
city: Fargo
country: United States
facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Cancer Center ( Site 0104)
state: North Dakota
city: Canton
country: United States
facility: Cleveland Clinic - Mercy Hospital ( Site 0057)
state: Ohio
city: Massillon
country: United States
facility: Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System ( Site 0025)
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical, LLC ( Site 0085)
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)
state: Oklahoma
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Jefferson ( Site 0049)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center ( Site 0059)
state: South Dakota
city: Germantown
country: United States
facility: West Cancer Center and Research Institute ( Site 0084)
state: Tennessee
city: Nashville
country: United States
facility: Nashville General Hospital ( Site 0072)
state: Tennessee
city: Amarillo
country: United States
facility: Harrington Cancer Center ( Site 0061)
state: Texas
city: Dallas
country: United States
facility: Parkland Health & Hospital System ( Site 0096)
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center ( Site 0032)
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology - Northeast Texas ( Site 8005)
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 0055)
state: Texas
city: Midlothian
country: United States
facility: Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute ( Site 0034)
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC ( Site 0093)
state: Washington
city: Madison
country: United States
facility: SSM Health Dean Medical Group ( Site 0087)
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Hospital Aleman-Oncology ( Site 0501)
state: Buenos Aires
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires-Oncology ( Site 0502)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Oncología Angel H. Roffo ( Site 0503)
state: Caba
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Instituto Alexander Fleming-Alexander Fleming ( Site 0509)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0512)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Sanatorio Finochietto ( Site 0513)
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508)
city: Macquarie University
country: Australia
facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 2700)
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701)
state: Queensland
city: Frankston
country: Australia
facility: Frankston Hospital-Oncology and Haematology ( Site 2704)
state: Victoria
city: Linz
country: Austria
facility: Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)
state: Oberosterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH ( Site 1205)
state: Oberosterreich
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck ( Site 1200)
state: Tirol
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202)
city: Wien
country: Austria
facility: Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201)
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)
state: Bruxelles-Capitale, Region De
city: Gent
country: Belgium
facility: AZ Maria Middelares-IKG ( Site 0903)
state: Oost-Vlaanderen
city: Namur
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)
city: Fortaleza
country: Brazil
facility: PRONUTRIR-CLINICAL RESEARCH ( Site 0609)
state: Ceara
city: Teresina
country: Brazil
facility: Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)
state: Piaui
city: Porto Alegre
country: Brazil
facility: Hospital do Câncer Mãe de Deus ( Site 0604)
state: Rio Grande Do Sul
city: Santa Cruz do Sul
country: Brazil
facility: Instituto de Oncologia Saint Gallen ( Site 0614)
state: Rio Grande Do Sul
city: Taubaté
country: Brazil
facility: Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: IBCC - Núcleo de Pesquisa e Ensino ( Site 0601)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0407)
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Vancouver ( Site 0404)
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 0411)
state: Manitoba
city: Moncton
country: Canada
facility: The Moncton Hospital ( Site 0401)
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre - Victoria General Site ( Site 0418)
state: Nova Scotia
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre ( Site 0413)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus ( Site 0414)
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital ( Site 0415)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0400)
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0416)
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal ( Site 0403)
state: Quebec
city: Rimouski
country: Canada
facility: Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409)
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406)
state: Quebec
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1005)
state: Brno-mesto
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1007)
state: Jihocesky Kraj
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)
state: Olomoucky Kraj
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze-Onkologická klinika VFN ( Site 1002)
state: Praha 2
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1000)
state: Praha 5
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala ( Site 1102)
state: Pirkanmaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1100)
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital-Department of Oncology ( Site 1103)
state: Varsinais-Suomi
city: Nice
country: France
facility: Centre Antoine-Lacassagne ( Site 1308)
state: Alpes-Maritimes
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque ( Site 1315)
state: Aquitaine
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1307)
state: Auvergne
city: Marseille
country: France
facility: Institut Paoli-Calmettes ( Site 1309)
state: Bouches-du-Rhone
city: Caen
country: France
facility: Centre François Baclesse ( Site 1318)
state: Calvados
city: Dijon
country: France
facility: Centre Georges François Leclerc ( Site 1312)
state: Cote-d Or
city: Besançon
country: France
facility: CHU Besançon ( Site 1311)
state: Doubs
city: Valence
country: France
facility: Hôpital Privé Drôme-Ardèche ( Site 1301)
state: Drome
city: Brest
country: France
facility: CHRU Brest - Hopital Cavale Blanche ( Site 1304)
state: Finistere
city: Bordeaux
country: France
facility: Clinique Tivoli Ducos ( Site 1322)
state: Gironde
city: Levallois-Perret
country: France
facility: Hôpital Franco-Britannique - Fondation Cognacq-Jay ( Site 1321)
state: Hauts-de-Seine
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest ( Site 1305)
state: Loire-Atlantique
city: ANGERS cedex 02
country: France
facility: Institut de Cancérologie de l'Ouest ( Site 1316)
state: Maine-et-Loire
city: Valenciennes
country: France
facility: Centre de Cancerologie Les Dentellieres ( Site 1306)
state: Nord
city: Pau
country: France
facility: Centre Hospitalier de Pau ( Site 1302)
state: Pyrenees-Atlantiques
city: Lyon Cedex08
country: France
facility: CENTRE LEON BERARD ( Site 1300)
state: Rhone-Alpes
city: Rouen
country: France
facility: Centre Henri Becquerel ( Site 1319)
state: Seine-Maritime
city: Paris
country: France
facility: Hôpital Tenon ( Site 1303)
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405)
state: Baden-Wurttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1400)
state: Bayern
city: Muenchen
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1402)
state: Bayern
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann-Frauenklinik ( Site 1408)
state: Brandenburg
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1409)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401)
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
facility: Evangelisches Krankenhaus Bethesda Mönchengladbach-Brustzentrum Niederrhein ( Site 1406)
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg Universität Mainz-Klinik und Poliklinik für Geburtshilfe und ( Site 1418)
state: Rheinland-Pfalz
city: Saarbrücken
country: Germany
facility: CaritasKlinikum Saarbrücken St. Theresia ( Site 1410)
state: Saarland
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein ( Site 1411)
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413)
city: Patras
country: Greece
facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1509)
state: Achaia
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508)
state: Attiki
city: Athens
country: Greece
facility: Aretaieio Hospital Oncology Unit ( Site 1505)
state: Attiki
city: Thessaloniki
country: Greece
facility: Agios Loukas Clinic ( Site 1507)
state: Kentriki Makedonia
city: Larissa
country: Greece
facility: University General Hospital of Larissa ( Site 1503)
state: Thessalia
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki-Oncology Unit ( Site 1502)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 3600)
city: Kowloon
country: Hong Kong
facility: Hong Kong United Oncology Centre ( Site 3601)
city: Cork
country: Ireland
facility: Bon Secours Cork Hospital ( Site 1600)
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1601)
city: Beer Sheva
country: Israel
facility: Soroka Medical Center-Oncology ( Site 1704)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 1700)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1702)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-ONCOLOGY ( Site 1701)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1705)
city: Naples
country: Italy
facility: University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803)
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1800)
state: Campania
city: Misterbianco
country: Italy
facility: Humanitas Istituto Clinico Catanese ( Site 1811)
state: Catania
city: Meldola (FC)
country: Italy
facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)
state: Forli-Cesena
city: Aviano
country: Italy
facility: CRO-IRCCS ( Site 1808)
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)
state: Lazio
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812)
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809)
state: Lombardia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801)
state: Lombardia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori ( Site 1813)
state: Lombardia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi ( Site 1805)
state: Toscana
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810)
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 1814)
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804)
city: Nagoya
country: Japan
facility: Nagoya City University Hospital ( Site 3414)
state: Aichi
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 3400)
state: Hokkaido
city: Isehara
country: Japan
facility: Tokai University Hospital ( Site 3413)
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 3405)
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital ( Site 3411)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 3412)
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital ( Site 3423)
state: Mie
city: Sendai
country: Japan
facility: Tohoku University Hospital ( Site 3422)
state: Miyagi
city: Suita
country: Japan
facility: The University of Osaka Hospital ( Site 3416)
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 3402)
state: Saitama
city: Bunkyo
country: Japan
facility: Juntendo University Hospital ( Site 3408)
state: Tokyo
city: Shinagawa
country: Japan
facility: Showa Medical University Hospital ( Site 3406)
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital ( Site 3407)
state: Tokyo
city: Shinjuku
country: Japan
facility: National Center for Global Health and Medicine ( Site 3409)
state: Tokyo
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital ( Site 3401)
city: Gifu
country: Japan
facility: Gifu University Hospital ( Site 3426)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 3418)
city: Kagoshima
country: Japan
facility: Social medical corporation Hakuaikai Sagara Hospital ( Site 3421)
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital ( Site 3420)
city: Kyoto
country: Japan
facility: Kyoto University Hospital ( Site 3415)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 3425)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 3417)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital-Internal Medicine ( Site 3102)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3100)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center-Department of Oncology ( Site 3103)
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Site 3104)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 3101)
city: Kuala Lumpur
country: Malaysia
facility: Prince Court Medical Centre ( Site 2802)
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur ( Site 2801)
city: Ciudad de México
country: Mexico
facility: CENEIT Oncologicos ( Site 0706)
state: Distrito Federal
city: Ciudad de México
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V: ( Site 0709)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 0712)
state: Distrito Federal
city: San Pedro Garza Garcia
country: Mexico
facility: CENTRO MEDICO ZAMBRANO HELLION ( Site 0711)
state: Nuevo Leon
city: Drammen
country: Norway
facility: Drammen Sykehus, Vestre Viken HF ( Site 2001)
state: Buskerud
city: Stavanger
country: Norway
facility: Stavanger Universitetssykehus ( Site 2004)
state: Rogaland
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Radiumhospitalet ( Site 2002)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2102)
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 2100)
state: Mazowieckie
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 2101)
state: Mazowieckie
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii ( Site 2105)
state: Podlaskie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 2113)
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 2110)
state: Slaskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2118)
state: Swietokrzyskie
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii ( Site 2108)
state: Zachodniopomorskie
city: Amadora
country: Portugal
facility: Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203)
state: Lisboa
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201)
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto ( Site 2202)
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore-Medical Oncology ( Site 3002)
state: Central Singapore
city: Sevilla
country: Spain
facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304)
state: Andalucia
city: L Hospitalet De Llobregat
country: Spain
facility: Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305)
state: Barcelona
city: A Coruña
country: Spain
facility: CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307)
state: La Coruna
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301)
state: Madrid, Comunidad De
city: Majadahonda
country: Spain
facility: HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308)
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Oncology ( Site 2300)
city: Madrid
country: Spain
facility: Hospital Beata María Ana-oncology ( Site 2309)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos-Oncology Department ( Site 2306)
city: Valencia
country: Spain
facility: HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302)
city: Thun
country: Switzerland
facility: Spital Thun ( Site 2400)
state: Berne
city: Geneva
country: Switzerland
facility: Clinique Générale-Beaulieu ( Site 2406)
state: Geneve
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden-Medizin ( Site 2404)
state: Grisons
city: Zürich
country: Switzerland
facility: Brust-Zentrum ( Site 2401)
state: Zurich
city: Fribourg
country: Switzerland
facility: HFR Fribourg - Hôpital Cantonal ( Site 2402)
city: Adana
country: Turkey
facility: Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2501)
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2504)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 2502)
city: Istanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi-oncology ( Site 2503)
city: Samsun
country: Turkey
facility: Samsun Medical Park Hastanesi-medical oncology ( Site 2500)
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust ( Site 2601)
state: Bristol, City Of
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital ( Site 2603)
state: England
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)
state: London, City Of
city: London
country: United Kingdom
facility: University College London Hospital ( Site 2604)
state: London, City Of
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 2607)
state: Midlothian
city: Leeds
country: United Kingdom
facility: St James's University Hospital-Leeds Cancer Centre ( Site 2608)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: