A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

NCT ID: NCT06966700

Last Updated: 2026-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2034-12-29

Brief Summary

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Researchers are looking for new ways to treat types of breast cancer that are both:

* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment
* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.

Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.

The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:

* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy
* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Detailed Description

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Conditions

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Breast Neoplasms Triple Negative Breast Neoplasms HR Low-Positive/HER2-Negative Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sac-TMT

Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m\^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m\^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m\^2 IV infusion Q3W/Q2W for 4 doses.

Group Type EXPERIMENTAL

Sacituzumab tirumotecan

Intervention Type BIOLOGICAL

IV infusion

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Rescue Medication

Intervention Type DRUG

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).

Carboplatin

Intervention Type DRUG

IV infusion

Paclitaxel

Intervention Type DRUG

IV infusion

Doxorubicin

Intervention Type DRUG

IV infusion

Epirubicin

Intervention Type DRUG

IV infusion

Cyclophosphamide

Intervention Type DRUG

IV infusion

Capecitabine

Intervention Type DRUG

Oral tablet

Olaparib

Intervention Type DRUG

Oral tablet

Chemotherapy

Participants receive IV carboplatin AUC 1.5 and paclitaxel 80 mg/m\^2 once weekly, alongside pembrolizumab 200 mg Q3W, for 6 weeks; then receive IV pembrolizumab 200 mg Q3W alongside IV cyclophosphamide 600 mg/m\^2 Q3W and either doxorubicin 60 mg/m\^2 Q3W or epirubicin 90 mg/m\^2 Q3W, for up to 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options are olaparib 300 mg oral BID for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); or capecitabine 1000-1250 mg/m\^2 oral BID on days 1-14 and 22-35 each cycle for 4 six-week cycles.

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Rescue Medication

Intervention Type DRUG

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).

Carboplatin

Intervention Type DRUG

IV infusion

Paclitaxel

Intervention Type DRUG

IV infusion

Doxorubicin

Intervention Type DRUG

IV infusion

Epirubicin

Intervention Type DRUG

IV infusion

Cyclophosphamide

Intervention Type DRUG

IV infusion

Capecitabine

Intervention Type DRUG

Oral tablet

Olaparib

Intervention Type DRUG

Oral tablet

Interventions

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Sacituzumab tirumotecan

IV infusion

Intervention Type BIOLOGICAL

Pembrolizumab

IV infusion

Intervention Type BIOLOGICAL

Rescue Medication

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).

Intervention Type DRUG

Carboplatin

IV infusion

Intervention Type DRUG

Paclitaxel

IV infusion

Intervention Type DRUG

Doxorubicin

IV infusion

Intervention Type DRUG

Epirubicin

IV infusion

Intervention Type DRUG

Cyclophosphamide

IV infusion

Intervention Type DRUG

Capecitabine

Oral tablet

Intervention Type DRUG

Olaparib

Oral tablet

Intervention Type DRUG

Other Intervention Names

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Sac-TMT MK-2870 MK-3475 Keytruda® Paraplatin Taxol Onxol ADRIAMYCIN® Ellence® Cytophosphane Xeloda® LYNPARZA®

Eligibility Criteria

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Inclusion Criteria

* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the investigator based on radiological and/or clinical assessment:

* cT1c, N1-N2
* cT2, N0-N2
* cT3, N0-N2
* cT4a-d, N0-N2
* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2-), as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before treatment randomization.
* Demonstrates adequate organ function.

Exclusion Criteria

* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
* Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received prior therapy with an anti-PD-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).
* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
* Received prior treatment with a topoisomerase I inhibitor-containing ADC.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Uncontrolled systemic disease.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Banner MD Anderson Cancer Center ( Site 0066)

Gilbert, Arizona, United States

Site Status RECRUITING

Roy and Patricia Disney Family Cancer Center ( Site 0055)

Burbank, California, United States

Site Status RECRUITING

Providence Medical Foundation ( Site 0080)

Fullerton, California, United States

Site Status RECRUITING

Hoag Memorial Hospital Presbyterian ( Site 0010)

Newport Beach, California, United States

Site Status RECRUITING

Helios Clinical Research ( Site 0061)

Whittier, California, United States

Site Status RECRUITING

Saint Joseph Hospital ( Site 0062)

Denver, Colorado, United States

Site Status RECRUITING

Intermountain Health St. Mary's Regional Hospital ( Site 0054)

Grand Junction, Colorado, United States

Site Status RECRUITING

Florida Cancer Specialists - South ( Site 7004)

Fort Myers, Florida, United States

Site Status RECRUITING

Bioresearch Partner ( Site 0072)

Hialeah, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists - North ( Site 7002)

St. Petersburg, Florida, United States

Site Status RECRUITING

Fort Wayne Medical Oncology and Hematology ( Site 0084)

Fort Wayne, Indiana, United States

Site Status RECRUITING

Franciscan Health ( Site 0077)

Indianapolis, Indiana, United States

Site Status RECRUITING

Ochsner Clinic Foundation ( Site 0021)

New Orleans, Louisiana, United States

Site Status RECRUITING

Louisiana State University Health Sciences Shreveport ( Site 0053)

Shreveport, Louisiana, United States

Site Status RECRUITING

New England Cancer Specialists ( Site 0051)

Westbrook, Maine, United States

Site Status RECRUITING

Mercy Medical Center - Baltimore ( Site 0015)

Baltimore, Maryland, United States

Site Status RECRUITING

Washington University Siteman Cancer Center ( Site 0031)

St Louis, Missouri, United States

Site Status RECRUITING

Cancer Partners of Nebraska ( Site 0068)

Lincoln, Nebraska, United States

Site Status RECRUITING

Renown Regional Medical Center ( Site 0041)

Reno, Nevada, United States

Site Status RECRUITING

Hackensack Univ Medical Center (HUMC) ( Site 0007)

Hackensack, New Jersey, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 0076)

New Brunswick, New Jersey, United States

Site Status RECRUITING

Altru Health System ( Site 0057)

Grand Forks, North Dakota, United States

Site Status RECRUITING

Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)

Cincinnati, Ohio, United States

Site Status RECRUITING

Avera McKennan Hospital ( Site 0002)

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Avera Cancer Institute - Yankton ( Site 0089)

Yankton, South Dakota, United States

Site Status RECRUITING

Tennessee Cancer Specialists ( Site 7001)

Knoxville, Tennessee, United States

Site Status RECRUITING

Nashville General Hospital ( Site 0017)

Nashville, Tennessee, United States

Site Status RECRUITING

Hendrick Medical Center ( Site 0009)

Abilene, Texas, United States

Site Status RECRUITING

JPS Oncology and Infusion Center ( Site 0083)

Fort Worth, Texas, United States

Site Status RECRUITING

Kelsey Research Foundation ( Site 0042)

Houston, Texas, United States

Site Status RECRUITING

Kelsey-Seybold Clinic ( Site 0088)

Houston, Texas, United States

Site Status RECRUITING

Oncology Consultants P.A. ( Site 0073)

Houston, Texas, United States

Site Status RECRUITING

Texas Oncology - San Antonio ( Site 8004)

San Antonio, Texas, United States

Site Status RECRUITING

Intermountain Medical Center ( Site 0074)

Murray, Utah, United States

Site Status RECRUITING

Bon Secours Cancer Institute at St. Francis ( Site 0048)

Midlothian, Virginia, United States

Site Status RECRUITING

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8005)

Roanoke, Virginia, United States

Site Status RECRUITING

Cancer Care Northwest ( Site 0003)

Spokane, Washington, United States

Site Status RECRUITING

Northwest Medical Specialties, PLLC ( Site 0067)

Tacoma, Washington, United States

Site Status RECRUITING

University of Wisconsin-Madison ( Site 0024)

Madison, Wisconsin, United States

Site Status RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 6008)

Mar del Plata, Buenos Aires, Argentina

Site Status RECRUITING

Hospital Italiano de Buenos Aires-ginecology ( Site 6003)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 6005)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Fundacion Ars Medica ( Site 6004)

San Salvador de Jujuy, Jujuy Province, Argentina

Site Status RECRUITING

Sanatorio Parque ( Site 6002)

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 6006)

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status RECRUITING

Sanatorio Finochietto ( Site 6007)

Buenos Aires, , Argentina

Site Status RECRUITING

Sanatorio Allende - Nueva Córdoba ( Site 6000)

Córdoba, , Argentina

Site Status RECRUITING

Sanatorio de la Cañada - Córdoba ( Site 6001)

Córdoba, , Argentina

Site Status RECRUITING

Chris O'Brien Lifehouse ( Site 1206)

Camperdown, New South Wales, Australia

Site Status RECRUITING

Monash Health ( Site 1201)

Clayton, Victoria, Australia

Site Status RECRUITING

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 3204)

Liège, Liege, Belgium

Site Status RECRUITING

Jessa Ziekenhuis ( Site 3200)

Hasselt, Limburg, Belgium

Site Status RECRUITING

AZORG Campus Aalst-Moorselbaan ( Site 3201)

Aalst, Oost-Vlaanderen, Belgium

Site Status RECRUITING

UZ Gent ( Site 3202)

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

CHU UCL Namur/Site Sainte Elisabeth ( Site 3203)

Namur, , Belgium

Site Status RECRUITING

PRONUTRIR ( Site 6120)

Fortaleza, Ceará, Brazil

Site Status RECRUITING

Hospital Araújo Jorge ( Site 6100)

Goiânia, Goiás, Brazil

Site Status RECRUITING

Liga Norte Riograndense Contra o Câncer ( Site 6111)

Natal, Rio Grande do Norte, Brazil

Site Status RECRUITING

Associação Hospitalar Beneficente São Vicente de Paulo ( Site 6115)

Passo Fundo, Rio Grande do Sul, Brazil

Site Status RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 6102)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital São Lucas da PUCRS ( Site 6103)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Clínica de Oncologia Reichow ( Site 6112)

Blumenau, Santa Catarina, Brazil

Site Status RECRUITING

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 6108)

Barretos, São Paulo, Brazil

Site Status RECRUITING

Hospital de Base de São José do Rio Preto ( Site 6101)

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

INCA Hospital do Câncer III ( Site 6107)

Rio de Janeiro, , Brazil

Site Status RECRUITING

NL Health Services ( Site 0232)

St. John's, Newfoundland and Labrador, Canada

Site Status RECRUITING

Health Sciences North ( Site 0234)

Greater Sudbury, Ontario, Canada

Site Status RECRUITING

Lakeridge Health ( Site 0225)

Oshawa, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre ( Site 0208)

Toronto, Ontario, Canada

Site Status RECRUITING

Jewish General Hospital ( Site 0200)

Montreal, Quebec, Canada

Site Status RECRUITING

CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0203)

Québec, Quebec, Canada

Site Status RECRUITING

CIUSSS de l'Estrie-CHUS ( Site 0206)

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Anhui Provincial Cancer Hospital ( Site 2234)

Hefei, Anhui, China

Site Status RECRUITING

Beijing Cancer Hospital ( Site 2201)

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2224)

Xiamen, Fujian, China

Site Status RECRUITING

Guangdong Maternity and Child Health Care Hospital ( Site 2251)

Guangzhou, Guangdong, China

Site Status RECRUITING

Jiangmen Center Hospital ( Site 2243)

Jiangmen, Guangdong, China

Site Status RECRUITING

Liuzhou People's Hospital ( Site 2259)

Liuchow, Guangxi, China

Site Status RECRUITING

Guangxi Medical University Affiliated Tumor Hospital ( Site 2223)

Nanning, Guangxi, China

Site Status RECRUITING

Harbin Medical University Cancer Hospital ( Site 2204)

Haerbin, Heilongjiang, China

Site Status RECRUITING

Henan Cancer Hospital ( Site 2238)

Zhengzhou, Henan, China

Site Status RECRUITING

Wuhan Union Hospital ( Site 2239)

Wuhan, Hubei, China

Site Status RECRUITING

Xiangya Hospital of Central South University ( Site 2225)

Changsha, Hunan, China

Site Status RECRUITING

Nanjing Drum Tower Hospital ( Site 2217)

Nanjing, Jiangsu, China

Site Status RECRUITING

Jiangsu Province Hospital ( Site 2216)

Nanjing, Jiangsu, China

Site Status RECRUITING

The Third Hospital Of Nanchang ( Site 2218)

Nanchang, Jiangxi, China

Site Status RECRUITING

The First Hospital Of Jilin University ( Site 2207)

Changchun, Jilin, China

Site Status RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2203)

Xi'an, Shaanxi, China

Site Status RECRUITING

Jinan Central Hospital ( Site 2249)

Jinan, Shandong, China

Site Status RECRUITING

Shandong Cancer Hospital ( Site 2205)

Jinan, Shandong, China

Site Status RECRUITING

Fudan University Shanghai Cancer Center ( Site 2209)

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Deyang City People's Hospital ( Site 2244)

Deyang, Sichuan, China

Site Status RECRUITING

The Second People's Hospital of Neijiang ( Site 2242)

Neijiang, Sichuan, China

Site Status RECRUITING

Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2230)

Ürümqi, Xinjiang, China

Site Status RECRUITING

Yunnan Province Cancer Hospital ( Site 2226)

Kunming, Yunnan, China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 2212)

Hangzhou, Zhejiang, China

Site Status RECRUITING

Zhejiang Cancer Hospital ( Site 2211)

Hangzhou, Zhejiang, China

Site Status ACTIVE_NOT_RECRUITING

Zhejiang Provincial People's Hospital ( Site 2215)

Hangzhou, Zhejiang, China

Site Status RECRUITING

Instituto de Cancerología-Oncology ( Site 6302)

Medellín, Antioquia, Colombia

Site Status RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 6311)

Bogotá, Bogota D.C., Colombia

Site Status RECRUITING

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6309)

Bogotá, Bogota D.C., Colombia

Site Status RECRUITING

IMAT S.A.S ( Site 6300)

Montería, Departamento de Córdoba, Colombia

Site Status RECRUITING

Oncologos del Occidente ( Site 6303)

Pereira, Risaralda Department, Colombia

Site Status RECRUITING

Fundación Valle del Lili ( Site 6308)

Cali, Valle del Cauca Department, Colombia

Site Status RECRUITING

Oulun yliopistollinen sairaala ( Site 3603)

Oulu, North Ostrobothnia, Finland

Site Status RECRUITING

Tampereen ylipistollinen sairaala ( Site 3601)

Tampere, Pirkanmaa, Finland

Site Status RECRUITING

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 3600)

Helsinki, Uusimaa, Finland

Site Status RECRUITING

Centre Georges Francois Leclerc ( Site 3902)

Dijon, Bourgogne-Franche-Comté, France

Site Status RECRUITING

Centre de Cancerologie du Grand Montpellier ( Site 3910)

Montpellier, Herault, France

Site Status RECRUITING

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 3900)

Rennes, Ille-et-Vilaine, France

Site Status RECRUITING

CHU d'Amiens-Picardie - Hôpital Sud ( Site 3908)

Amiens, Somme, France

Site Status RECRUITING

HENRI MONDOR HOSPITAL ( Site 3904)

Créteil, Val-de-Marne, France

Site Status RECRUITING

MEDI-K ( Site 6400)

Guatemala City, , Guatemala

Site Status RECRUITING

CELAN,S.A ( Site 6401)

Guatemala City, , Guatemala

Site Status RECRUITING

INTEGRA Cancer Institute ( Site 6404)

Guatemala City, , Guatemala

Site Status RECRUITING

Onco Go, S.A ( Site 6402)

Guatemala City, , Guatemala

Site Status RECRUITING

Asociacion Española de Beneficencia ( Site 6403)

Guatemala City, , Guatemala

Site Status RECRUITING

Hong Kong United Oncology Centre ( Site 1304)

Jordan, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital ( Site 1300)

Pokfulam, , Hong Kong

Site Status RECRUITING

Prince of Wales Hospital ( Site 1301)

Shatin, , Hong Kong

Site Status RECRUITING

Tuen Mun Hospital ( Site 1303)

Tuenmen, , Hong Kong

Site Status RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 4207)

Kecskemét, Bács-Kiskun county, Hungary

Site Status RECRUITING

Rambam Health Care Campus ( Site 4400)

Haifa, , Israel

Site Status RECRUITING

Meir Medical Center. ( Site 4403)

Kfar Saba, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 4401)

Ramat Gan, , Israel

Site Status RECRUITING

Yitzhak Shamir Medical Center. ( Site 4404)

Ẕerifin, , Israel

Site Status RECRUITING

Nagoya City University Hospital ( Site 2310)

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

National Hospital Organization Hokkaido Cancer Center ( Site 2300)

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Kanagawa Cancer Center ( Site 2308)

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Mie University Hospital ( Site 2312)

Tsu, Mie-ken, Japan

Site Status RECRUITING

Kansai Medical University Hospital ( Site 2317)

Hirakata, Osaka, Japan

Site Status RECRUITING

Kindai University Hospital ( Site 2316)

Sakai, Osaka, Japan

Site Status RECRUITING

The University of Osaka Hospital ( Site 2314)

Suita, Osaka, Japan

Site Status RECRUITING

Shizuoka Cancer Center ( Site 2309)

Sunto-gun, Shizuoka, Japan

Site Status RECRUITING

National Cancer Center Hospital ( Site 2305)

Chūō, Tokyo, Japan

Site Status RECRUITING

Toranomon Hospital ( Site 2307)

Minato, Tokyo, Japan

Site Status RECRUITING

Showa Medical University Hospital ( Site 2306)

Shinagawa, Tokyo, Japan

Site Status RECRUITING

Akita University Hospital ( Site 2302)

Akita, , Japan

Site Status RECRUITING

Chiba Cancer Center ( Site 2303)

Chiba, , Japan

Site Status RECRUITING

Fukushima Medical University Hospital ( Site 2301)

Fukushima, , Japan

Site Status RECRUITING

Hiroshima City Hiroshima Citizens Hospital ( Site 2318)

Hiroshima, , Japan

Site Status RECRUITING

Kumamoto Shinto General Hospital ( Site 2322)

Kumamoto, , Japan

Site Status RECRUITING

Kyoto University Hospital ( Site 2313)

Kyoto, , Japan

Site Status RECRUITING

Nakagami Hospital ( Site 2323)

Okinawa, , Japan

Site Status RECRUITING

National Hospital Organization Osaka National Hospital ( Site 2315)

Osaka, , Japan

Site Status RECRUITING

Hospital Pulau Pinang ( Site 1502)

George Town, Pulau Pinang, Malaysia

Site Status RECRUITING

National Cancer Institute ( Site 1501)

Putrajaya, Putrajaya, Malaysia

Site Status RECRUITING

Sarawak General Hospital ( Site 1504)

Kuching, Sarawak, Malaysia

Site Status RECRUITING

Pantai Hospital Kuala Lumpur ( Site 1500)

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 6605)

Concepción, Departamento de Junín, Peru

Site Status RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 6600)

Lima, , Peru

Site Status RECRUITING

Oncosalud ( Site 6603)

Lima, , Peru

Site Status RECRUITING

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 4616)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 4612)

Krakow, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 4609)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 4614)

Olsztyn, Warmian-Masurian Voivodeship, Poland

Site Status RECRUITING

Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 4702)

Lisbon, Lisbon District, Portugal

Site Status RECRUITING

Hospital de Cascais Doutor José de Almeida ( Site 4700)

Lisbon, , Portugal

Site Status RECRUITING

National Cancer Centre Singapore ( Site 1700)

Singapore, Central Singapore, Singapore

Site Status RECRUITING

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4907)

Port Elizabeth, Eastern Cape, South Africa

Site Status RECRUITING

Wits Clinical Research ( Site 4903)

Johannesburg, Gauteng, South Africa

Site Status RECRUITING

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4901)

Pretoria, Gauteng, South Africa

Site Status RECRUITING

Sandton Oncology Medical Group (Pty) Ltd ( Site 4900)

Sandton, Gauteng, South Africa

Site Status RECRUITING

Cancercare Rondebosch Oncology ( Site 4906)

Cape Town, Western Cape, South Africa

Site Status RECRUITING

National Cancer Center ( Site 1800)

Goyang-si, Kyonggi-do, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital ( Site 1801)

Kyonggi-do, Kyonggi-do, South Korea

Site Status RECRUITING

Kyungpook National University Chilgok Hospital ( Site 1805)

Taegu, Taegu-Kwangyokshi, South Korea

Site Status RECRUITING

Seoul National University Hospital ( Site 1806)

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital Yonsei University Health System ( Site 1804)

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center ( Site 1803)

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center ( Site 1807)

Seoul, , South Korea

Site Status RECRUITING

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1802)

Seoul, , South Korea

Site Status RECRUITING

Institut Català d'Oncologia - L'Hospitalet ( Site 5001)

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital de Basurto ( Site 5007)

Bilbao, Bizkaia, Spain

Site Status RECRUITING

Complejo asistencial universitario de Salamanca ( Site 5000)

Salamanca, Castille and León, Spain

Site Status RECRUITING

HOSPITAL UNIVERSITARIO DE JAEN ( Site 5003)

Jaén, Jaen, Spain

Site Status RECRUITING

CHUS - Hospital Clinico Universitario ( Site 5006)

Santiago de Compostela, La Coruna, Spain

Site Status RECRUITING

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 5004)

Pozuelo de Alarcón, Madrid, Spain

Site Status RECRUITING

Hospital General de Valencia ( Site 5008)

Valencia, Valenciana, Comunitat, Spain

Site Status RECRUITING

Parc de Salut Mar - Hospital del Mar ( Site 5005)

Barcelona, , Spain

Site Status RECRUITING

Hospital Beata María Ana ( Site 5010)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena ( Site 5002)

Seville, , Spain

Site Status RECRUITING

Skånes Universitetssjukhus Malmö ( Site 3802)

Malmo, Skåne County, Sweden

Site Status RECRUITING

Karolinska Universitetssjukhuset Solna ( Site 3800)

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Akademiska sjukhuset ( Site 3801)

Uppsala, Uppsala County, Sweden

Site Status RECRUITING

Södra Älvsborgs Sjukhus Borås ( Site 3804)

Borås, Västra Götaland County, Sweden

Site Status RECRUITING

Taichung Veterans General Hospital ( Site 1904)

Taichung, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital ( Site 1900)

Taipei, , Taiwan

Site Status RECRUITING

MacKay Memorial Hospital ( Site 1903)

Taipei, , Taiwan

Site Status RECRUITING

National Taiwan University Cancer Center (NTUCC) ( Site 1901)

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Medical Foundation-Linkou Branch ( Site 1906)

Taoyuan District, , Taiwan

Site Status RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 2000)

Bangkok, Bangkok, Thailand

Site Status RECRUITING

COMMUNAL NONPROFIT ENTERPRISE "CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 5207)

Cherkasy, Cherkasy Oblast, Ukraine

Site Status RECRUITING

Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 5208)

Chernivtsi, Chernivetska Oblast, Ukraine

Site Status RECRUITING

CNCE Precarpathian Clinical Oncologic Center ( Site 5201)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status RECRUITING

CNE Regional clinical oncology center of Kirovograd regional Council ( Site 5203)

Kropyvnytsky, Kirovohrad Oblast, Ukraine

Site Status RECRUITING

Shalimov Institute of Surgery and Transplantation ( Site 5210)

Kyiv, , Ukraine

Site Status RECRUITING

Ninewells Hospital and Medical School ( Site 5300)

Dundee, Dundee City, United Kingdom

Site Status RECRUITING

Huddersfield Royal Infirmary ( Site 5313)

Huddersfield, England, United Kingdom

Site Status RECRUITING

St Bartholomew s Hospital ( Site 5302)

London, London, City of, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Brazil Canada China Colombia Finland France Guatemala Hong Kong Hungary Israel Japan Malaysia Peru Poland Portugal Singapore South Africa South Korea Spain Sweden Taiwan Thailand Ukraine United Kingdom

Central Contacts

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Toll Free Number

Role: CONTACT

1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

480-256-6444

Study Coordinator

Role: primary

818-840-0921

Study Coordinator

Role: primary

714-446-5900

Study Coordinator

Role: primary

949-764-4624

Study Coordinator

Role: primary

562-698-6888

Study Coordinator

Role: primary

303-318-3434

Study Coordinator

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970-298-7638

Study Coordinator

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239-274-9930

Study Coordinator

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888-577-8839

Study Coordinator

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727-216-1143

Study Coordinator

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260-436-0800

Study Coordinator

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317-528-7060

Study Coordinator

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866-624-7637

Study Coordinator

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318-626-0000

Study Coordinator

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207-303-3300

Study Coordinator

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410-951-7956

Study Coordinator

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314-286-2341

Study Coordinator

Role: primary

402-327-7363

Study Coordinator

Role: primary

775-982-4000

Study Coordinator

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551-996-5855

Study Coordinator

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732-253-3939

Study Coordinator

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701-780-5451

Study Coordinator

Role: primary

513-853-1300

Study Coordinator

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605-322-3000

Study Coordinator

Role: primary

605-601-1830

Study Coordinator

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865-934-5800

Study Coordinator

Role: primary

615-341-4383

Study Coordinator

Role: primary

325-670-2000

Study Coordinator

Role: primary

817-702-8049

Study Coordinator

Role: primary

713-239-4510

Study Coordinator

Role: primary

713-239-4510

Study Coordinator

Role: primary

713-275-3233

Study Coordinator

Role: primary

210-595-5300

Study Coordinator

Role: primary

801-507-3630

Study Coordinator

Role: primary

804-893-8717

Study Coordinator

Role: primary

540-982-0237

Study Coordinator

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509-228-1000

Study Coordinator

Role: primary

253-428-8700

Study Coordinator

Role: primary

608-263-0796

Study Coordinator

Role: primary

+542234963224

Study Coordinator

Role: primary

+541149584546

Study Coordinator

Role: primary

+549 1152990000

Study Coordinator

Role: primary

+54 3884315604

Study Coordinator

Role: primary

+5493416955611

Study Coordinator

Role: primary

+543814502600

Study Coordinator

Role: primary

+54 11 58216233

Study Coordinator

Role: primary

08105552553

Study Coordinator

Role: primary

08101225800

Study Coordinator

Role: primary

61 02 8514 0000

Study Coordinator

Role: primary

61 3 8572 5402

Study Coordinator

Role: primary

+3243232311

Study Coordinator

Role: primary

+32 11 33 79 92

Study Coordinator

Role: primary

+3253724111

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

+3281720547

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

7097772638

Study Coordinator

Role: primary

7055237100

Study Coordinator

Role: primary

9055768711

Study Coordinator

Role: primary

4169462000

Study Coordinator

Role: primary

514-340-8222

Study Coordinator

Role: primary

4185254444

Study Coordinator

Role: primary

8193461110

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

0750-3385319

Study Coordinator

Role: primary

0772-2662950

Study Coordinator

Role: primary

0771-5308635

Study Coordinator

Role: primary

0451-86298104

Study Coordinator

Role: primary

0371-65587295

Study Coordinator

Role: primary

027-85726273

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

0431-88786014

Study Coordinator

Role: primary

029-85324421

Study Coordinator

Role: primary

0531-55739999

Study Coordinator

Role: primary

0531-87984777

Study Coordinator

Role: primary

021-6417 5590

Study Coordinator

Role: primary

0838-2591961

Study Coordinator

Role: primary

0832-2380771

Study Coordinator

Role: primary

0991-7819086

Study Coordinator

Role: primary

13608815577

Study Coordinator

Role: primary

0571-86992521

Study Coordinator

Role: primary

0571-87666666

Study Coordinator

Role: primary

+576043409393

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

0033322088000

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

+972-507324996

Study Coordinator

Role: primary

+81-52-858-7215

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

+81-6-6210-8290

Study Coordinator

Role: primary

+81-55-989-5222

Study Coordinator

Role: primary

+81-3-3547-5201

Study Coordinator

Role: primary

+81-3-3588-1111

Study Coordinator

Role: primary

+81-3-3784-8000

Study Coordinator

Role: primary

+81-18-834-1111

Study Coordinator

Role: primary

+81-43-264-5431

Study Coordinator

Role: primary

+81-24-547-1111

Study Coordinator

Role: primary

+81-82-221-2291

Study Coordinator

Role: primary

+81-96-364-6000

Study Coordinator

Role: primary

+81-75-751-4389

Study Coordinator

Role: primary

+81-98-939-1300

Study Coordinator

Role: primary

+81-6-6942-1331

Study Coordinator

Role: primary

+604-2225333

Study Coordinator

Role: primary

+60124332344

Study Coordinator

Role: primary

+60182327023

Study Coordinator

Role: primary

+603-2296 0888

Study Coordinator

Role: primary

+51 958 864 658

Study Coordinator

Role: primary

6600

Study Coordinator

Role: primary

+51957511783

Study Coordinator

Role: primary

+48523743525

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

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+48895398078

Study Coordinator

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+351210431000

Study Coordinator

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+351214653000

Study Coordinator

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+6564368000

Study Coordinator

Role: primary

+27414506154

Study Coordinator

Role: primary

27113390600

Study Coordinator

Role: primary

27123466701

Study Coordinator

Role: primary

27118830900

Study Coordinator

Role: primary

27(0)21 9443700

Study Coordinator

Role: primary

+82319200396

Study Coordinator

Role: primary

+82317873942

Study Coordinator

Role: primary

82532002624

Study Coordinator

Role: primary

82220720795

Study Coordinator

Role: primary

+82222288135

Study Coordinator

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+82230103215

Study Coordinator

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Study Coordinator

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8222586048

Study Coordinator

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Study Coordinator

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Study Coordinator

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+923.291100X55749

Study Coordinator

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+34953220306

Study Coordinator

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+34 663609134

Study Coordinator

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+34914521987

Study Coordinator

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+34963131800-437639

Study Coordinator

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+34 932483860

Study Coordinator

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+ 34 914097423

Study Coordinator

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+34955008000

Study Coordinator

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4640331000

Study Coordinator

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0046812370000

Study Coordinator

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0046186110000

Study Coordinator

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46336161000

Study Coordinator

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886423592525x5031

Study Coordinator

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

+886-223123456x65422

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

380955077568

Study Coordinator

Role: primary

+380342759071

Study Coordinator

Role: primary

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Study Coordinator

Role: primary

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Study Coordinator

Role: primary

+441382660111

Study Coordinator

Role: primary

0044 1484 342905

Study Coordinator

Role: primary

+442073777000

Related Links

Access external resources that provide additional context or updates about the study.

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1316-7898

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-520190-12-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2031250231

Identifier Type: REGISTRY

Identifier Source: secondary_id

2870-032

Identifier Type: -

Identifier Source: org_study_id

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