Spots Global Cancer Trial Database for Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)
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Trial Identification
Brief Title: Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)
Official Title: A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer
Study ID: NCT04956692
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state. Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Bernards Medical Center ( Site 0103), Jonesboro, Arkansas, United States
St Joseph Heritage Healthcare-Oncology ( Site 0102), Fullerton, California, United States
Cancer Blood and Specialty Clinic ( Site 0105), Los Alamitos, California, United States
PIH Health Hematology Medical Oncology ( Site 0106), Whittier, California, United States
Holy Cross Hospital ( Site 0017), Fort Lauderdale, Florida, United States
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104), Hollywood, Florida, United States
Advent Health ( Site 0013), Orlando, Florida, United States
Fort Wayne Medical Oncology and Hematology ( Site 0101), Fort Wayne, Indiana, United States
Baptist Health Lexington ( Site 0099), Lexington, Kentucky, United States
St Luke's Hospital - Kansas City ( Site 0033), Kansas City, Missouri, United States
St. Vincent Frontier Cancer Center ( Site 0058), Billings, Montana, United States
Montefiore Medical Center [Bronx, NY] ( Site 0040), Bronx, New York, United States
The University of Tennessee Medical Center ( Site 0050), Knoxville, Tennessee, United States
Tennessee Oncology ( Site 0051), Nashville, Tennessee, United States
Oncology Consultants, PA ( Site 0052), Houston, Texas, United States
Millennium Physicians - Oncology ( Site 0097), Houston, Texas, United States
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100), Blacksburg, Virginia, United States
West Virginia University ( Site 0056), Morgantown, West Virginia, United States
HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307), Cachoeiro de Itapemirim, Espirito Santo, Brazil
Hospital Sao Vicente de Paulo ( Site 0311), Passo Fundo, Rio Grande Do Sul, Brazil
Instituto Joinvilense de Hematologia e Oncologia ( Site 0308), Joinville, Santa Catarina, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305), Sao Jose do Rio Preto, Sao Paulo, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304), São Paulo, Sao Paulo, Brazil
Nouvel Hôpital Civil (NHC) ( Site 1018), Strasbourg, Bas-Rhin, France
CHU Limoges CHU Dupuytren ( Site 1011), Limoges, Haute-Vienne, France
Hôpital Foch ( Site 1019), Suresnes, Hauts-de-Seine, France
Institut Regional du Cancer de Montpellier - ICM ( Site 1003), Montpellier, Herault, France
Centre Hospitalier Sud Réunion ( Site 1020), Saint-Pierre, La Reunion, France
Hopital Guillaume & Rene Laennec ( Site 1007), Saint-Herblain, Loire-Atlantique, France
Centre Hospitalier de Pau ( Site 1016), Pau, Pyrenees-Atlantiques, France
CHU de Rouen ( Site 1013), Rouen, Seine-Maritime, France
Hopital Cochin ( Site 1002), Paris, , France
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602), Guatemala, , Guatemala
Clinica Privada Dr. Rixci Ramirez ( Site 0601), Guatemala, , Guatemala
INTERVASC ( Site 0605), Guatemala, , Guatemala
Grupo Angeles SA ( Site 0604), Guatemala, , Guatemala
Centro Regional de Sub Especialidades Médicas SA ( Site 0600), Quetzaltenango, , Guatemala
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106), Kecskemét, Bacs-Kiskun, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1110), Gyor, Gyor-Moson-Sopron, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103), Szolnok, Jasz-Nagykun-Szolnok, Hungary
Tudogyogyintezet Torokbalint ( Site 1105), Torokbalint, Pest, Hungary
Veszprem Megyei Tudogyogyintezet ( Site 1108), Farkasgyepu, Veszprem, Hungary
Zala Megyei Szent Rafael Korhaz ( Site 1111), Zalagerszeg, Zalaegerszeg, Hungary
Semmelweis University-Pulmonológiai Klinika ( Site 1114), Budapest, , Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 1104), Budapest, , Hungary
Fujita Health University Hospital ( Site 3007), Toyoake, Aichi, Japan
Ehime University Hospital ( Site 3005), Toon, Ehime, Japan
Kurume University Hospital ( Site 3006), Kurume, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 3014), Sapporo, Hokkaido, Japan
Kanazawa University Hospital ( Site 3004), Kanazawa, Ishikawa, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 3003), Yokohama, Kanagawa, Japan
Miyagi Cancer Center ( Site 3000), Natori, Miyagi, Japan
Sendai Kousei Hospital ( Site 3015), Sendai, Miyagi, Japan
Kurashiki Central Hospital ( Site 3013), Kurashiki, Okayama, Japan
Kansai Medical University Hospital ( Site 3016), Hirakata, Osaka, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009), Sakai, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 3017), Takatsuki, Osaka, Japan
Chiba University Hospital ( Site 3008), Chiba, , Japan
National Hospital Organization Kyushu Medical Center ( Site 3001), Fukuoka, , Japan
National Hospital Organization Kyushu Cancer Center ( Site 3002), Fukuoka, , Japan
Okayama University Hospital ( Site 3012), Okayama, , Japan
Osaka International Cancer Institute ( Site 3018), Osaka, , Japan
Tokushima University Hospital ( Site 3019), Tokushima, , Japan
Juntendo University Hospital ( Site 3011), Tokyo, , Japan
Showa University Hospital ( Site 3010), Tokyo, , Japan
Chungnam National University Hospital ( Site 2002), Daejeon, Chungnam, Korea, Republic of
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000), Hwasun, Jeonranamdo, Korea, Republic of
Korea University Guro Hospital ( Site 2003), Seoul, , Korea, Republic of
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704), Arequipa, Ariqipa, Peru
Clínica Peruano-Americana de Trujillo ( Site 0701), Trujillo, La Libertad, Peru
Oncosalud ( Site 0706), Lima, Muni Metro De Lima, Peru
Clinica Internacional Sede San Borja ( Site 0705), Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas ( Site 0703), Lima, , Peru
Hospital Nacional Cayetano Heredia ( Site 0700), Lima, , Peru
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201), Bydgoszcz, Kujawsko-pomorskie, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206), Siedlce, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205), Bystra, Slaskie, Poland
Przychodnia Lekarska KOMED ( Site 1202), Konin, Wielkopolskie, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200), Koszalin, Zachodniopomorskie, Poland
Cardiomed SRL Cluj-Napoca ( Site 1313), Cluj-Napoca, Cluj, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303), Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL ( Site 1307), Comuna Floresti, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304), Craiova, Dolj, Romania
Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312), Craiova, Dolj, Romania
Spitalul Municipal Ploiesti ( Site 1308), Ploiesti, Prahova, Romania
Policlinica Oncomed SRL ( Site 1302), Timisoara, Timis, Romania
S.C.Focus Lab Plus S.R.L ( Site 1301), Bucuresti, , Romania
Spitalul Universitar de Urgenta Bucuresti ( Site 1305), Bucuresti, , Romania
SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406), Saint-Petersburg, Sankt-Peterburg, Russian Federation
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425), Kazan, Tatarstan, Respublika, Russian Federation
SPb SBHI City Clinical Oncological Dispensary ( Site 1409), Sankt-Peterburg, , Russian Federation
Wits Clinical Research ( Site 1510), Johannesburg, Gauteng, South Africa
Steve Biko Academic Hospital ( Site 1506), Pretoria, Gauteng, South Africa
Marry Potter Oncology Centre ( Site 1502), Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 1505), Sandton, Gauteng, South Africa
Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513), Soweto, Gauteng, South Africa
The Oncology Centre ( Site 1507), Durban, Limpopo, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 1500), Kraaifontein, Western Cape, South Africa
Hospital Insular de Gran Canaria-Oncology ( Site 1604), Las Palmas de Gran Canaria, Las Palmas, Spain
H.U. Vall de Hebron ( Site 1600), Barcelona, , Spain
Hospital Juan Ramon Jimenez ( Site 1602), Huelva, , Spain
Hospital Universitario Lucus Augusti ( Site 1603), Lugo, , Spain
Hospital Universitario La Paz ( Site 1601), Madrid, , Spain
Changhua Christian Hospital ( Site 2104), Changhua, , Taiwan
National Taiwan University Hospital Hsin-Chu Branch ( Site 2103), Hsinchu, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107), Kaohsiung, , Taiwan
National Cheng Kung University Hospital ( Site 2105), Tainan, , Taiwan
National Taiwan University Hospital ( Site 2101), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 2106), Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 2102), Taoyuan, , Taiwan
Gulhane Egitim ve Arastirma Hastanesi ( Site 1704), Ankara, , Turkey
Ankara Sehir Hastanesi ( Site 1702), Ankara, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701), Istanbul, , Turkey
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703), Izmir, , Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707), Malatya, , Turkey
Medical Center Mriya Med-Service ( Site 1805), Kryvyi Rih, Dnipropetrovska Oblast, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806), Kharkiv, Kharkivska Oblast, Ukraine
Ukrainian Center of Tomotherapy ( Site 1807), Kropyvnytskyi, Kirovohradska Oblast, Ukraine
Medical Center Asklepion LLC ( Site 1804), Khodosivka, Kyivska Oblast, Ukraine
Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181, Odesa, Odeska Oblast, Ukraine
Kremenchuk Regional Oncology Center ( Site 1811), Kremenchuk, Poltavska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 1809), Kyiv, , Ukraine
Medical Center Dobrobut Clinic ( Site 1808), Kyiv, , Ukraine
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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