Spots Global Cancer Trial Database for A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
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Trial Identification
Brief Title: A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
Official Title: A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
Study ID: NCT05722015
Conditions
Study Description
Brief Summary: This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023), Phoenix, Arizona, United States
Clermont Oncology Center ( Site 0018), Clermont, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 0010), Orange City, Florida, United States
University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022), Chicago, Illinois, United States
Orchard Healthcare Research Inc. ( Site 0011), Skokie, Illinois, United States
Franciscan Health Lafayette East ( Site 0020), Lafayette, Indiana, United States
Mercy Health-Paducah Medical Oncology and Hematology ( Site 0006), Paducah, Kentucky, United States
Hattiesburg Clinic Hematology/Oncology ( Site 0008), Hattiesburg, Mississippi, United States
Central Care Cancer Center - Bolivar ( Site 0017), Bolivar, Missouri, United States
Instituto Alexander Fleming ( Site 1008), Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001), Mar del Plata, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005), ABB, Caba, Argentina
Sanatorio Parque ( Site 1003), Rosario, Santa Fe, Argentina
Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002), Buenos Aires, , Argentina
Clinica Adventista Belgrano-Oncology ( Site 1004), Caba, , Argentina
Hospital Italiano de Córdoba ( Site 1000), Cordoba, , Argentina
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102), Fortaleza, Ceara, Brazil
Hospital de Câncer de Recife ( Site 1107), Recife, Pernambuco, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100), Porto Alegre, Rio Grande Do Sul, Brazil
Instituto Joinvilense de Hematologia e Oncologia ( Site 1101), Joinville, Santa Catarina, Brazil
A. C. Camargo Cancer Center ( Site 1106), Sao Paulo, , Brazil
IC La Serena Research ( Site 1207), La Serena, Coquimbo, Chile
Oncocentro Valdivia ( Site 1201), Valdivia, Los Rios, Chile
FALP-UIDO ( Site 1203), Santiago, Region M. De Santiago, Chile
Oncovida ( Site 1209), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210), Santiago, Region M. De Santiago, Chile
Instituto Nacional del Cancer-CR Investigación ( Site 1211), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 1202), Santiago, Region M. De Santiago, Chile
Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503), Hefei, Anhui, China
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510), Beijing, Beijing, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501), Beijing, Beijing, China
Beijing Chest Hospital,Capital Medical University ( Site 4511), Beijing, Beijing, China
Chongqing Three Gorges Central Hospital ( Site 4516), Wanzhou, Chongqing, China
Fujian Provincial Cancer Hospital ( Site 4517), Fuzhou, Fujian, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (, Guangzhou, Guangdong, China
Jiangmen Center Hospital ( Site 4509), Jiangmen, Guangdong, China
ShenZhen People's Hospital ( Site 4504), Shenzhen, Guangdong, China
Wuhan Union Hospital Cancer Center-Cancer center ( Site 4502), Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515), Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520), Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center-Oncology ( Site 4512), Shanghai, Shanghai, China
Shanxi Cancer Hospital ( Site 4521), Taiyuan, Shanxi, China
Tianjin Chest Hospital ( Site 4518), Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514), Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 4508), Taizhou, Zhejiang, China
Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600), Quimper, Finistere, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602), Tours, Indre-et-Loire, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603), Paris, , France
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404), Ciudad de Guatemala, , Guatemala
MEDI-K CAYALA ( Site 1403), Guatemala, , Guatemala
Centro Regional de Sub Especialidades Médicas SA ( Site 1401), Quetzaltenango, , Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 1400), Quetzaltenango, , Guatemala
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102), Kecskemét, Bacs-Kiskun, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103), Szolnok, Jasz-Nagykun-Szolnok, Hungary
Törökbálinti Tüdőgyógyintézet ( Site 2105), Törökbálint, Pest, Hungary
Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104), Budapest, , Hungary
Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100), Budapest, , Hungary
Fujita Health University ( Site 4406), Toyoake, Aichi, Japan
Kurume University Hospital ( Site 4412), Kurume, Fukuoka, Japan
Gunma Prefectural Cancer Center ( Site 4416), Otashi, Gunma, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 4415), Sapporo, Hokkaido, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 4404), Yokohama, Kanagawa, Japan
Miyagi Cancer Center ( Site 4401), Natori, Miyagi, Japan
Sendai Kousei Hospital ( Site 4400), Sendai, Miyagi, Japan
Kurashiki Central Hospital ( Site 4409), Kurashiki, Okayama, Japan
Kansai Medical University Hospital ( Site 4408), Hirakata, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 4414), Takatsuki, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 4402), Ina-machi, Saitama, Japan
Shizuoka Cancer Center ( Site 4405), Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
Tochigi Cancer Center ( Site 4417), Utsunomiya, Tochigi, Japan
Juntendo University Hospital ( Site 4413), Bunkyo-ku, Tokyo, Japan
National Hospital Organization Kyushu Medical Center ( Site 4411), Fukuoka, , Japan
National Hospital Organization Kyushu Cancer Center ( Site 4410), Fukuoka, , Japan
Osaka International Cancer Institute ( Site 4407), Osaka, , Japan
Nippon Medical School Hospital ( Site 4403), Tokyo, , Japan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier, Warszawa, Mazowieckie, Poland
Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii, Olsztyn, Warminsko-mazurskie, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801), Koszalin, Zachodniopomorskie, Poland
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303), Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2301), Craiova, Dolj, Romania
Cabinet Medical Oncomed ( Site 2305), Timișoara, Timis, Romania
Institutul Oncologic-Oncologie Medicala ( Site 2302), Cluj, , Romania
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903), Port Elizabeth, Eastern Cape, South Africa
Medical Oncology Centre of Rosebank ( Site 2907), Johannesburg, Gauteng, South Africa
Steve Biko Academic Hospital-Medical Oncology ( Site 2904), Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900), Sandton, Gauteng, South Africa
The Oncology Centre ( Site 2901), Durban, Kwazulu-Natal, South Africa
Cape Town Oncology Trials ( Site 2902), Cape Town, Western Cape, South Africa
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404), Santiago de Compostela, La Coruna, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401), Madrid, Madrid, Comunidad De, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 2400), Barcelona, , Spain
Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402), Huelva, , Spain
Changhua Christian Hospital ( Site 4203), Changhua County, Changhua, Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 4200), Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 4205), Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207), Kaohsiung, , Taiwan
E-Da hospital ( Site 4208), Kaohsiung, , Taiwan
National Cheng Kung University Hospital ( Site 4202), Tainan, , Taiwan
National Taiwan University Hospital-Oncology ( Site 4204), Taipei, , Taiwan
Maharaj Nakorn Chiang Mai Hospital ( Site 4300), Muang, Chiang Mai, Thailand
Chulalongkorn University ( Site 4301), Bangkok, Krung Thep Maha Nakhon, Thailand
Division of Medical Oncology, Siriraj H ( Site 4303), Siriraj, Krung Thep Maha Nakhon, Thailand
Songklanagarind hospital ( Site 4302), Hatyai, Songkhla, Thailand
I.E.U. Medical Point Hastanesi-Oncology ( Site 2507), Izmir, Karsiyaka, Izmir, Turkey
Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504), Ankara, , Turkey
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506), Ankara, , Turkey
Ankara City Hospital-Medical Oncology ( Site 2501), Ankara, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502), Istanbul, , Turkey
Memorial Kayseri Hastanesi ( Site 2500), Kayseri, , Turkey
İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503), Malatya, , Turkey
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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