Spots Global Cancer Trial Database for A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)
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Trial Identification
Brief Title: A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects With Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)
Study ID: NCT03066778
Conditions
Study Description
Brief Summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum \[EP\]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy. The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Baptist Health Medical Group Oncology, LLC ( Site 8000), Miami, Florida, United States
Rush University Medical Center ( Site 1215), Chicago, Illinois, United States
North Shore University Health System ( Site 1216), Evanston, Illinois, United States
Community Hospital ( Site 1207), Munster, Indiana, United States
Weinberg Cancer Institute at Franklin Square ( Site 1210), Baltimore, Maryland, United States
Massachusetts General Hospital ( Site 1203), Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center ( Site 1206), Boston, Massachusetts, United States
Dana-Farber Cancer Institute [Boston] ( Site 1201), Boston, Massachusetts, United States
University of Michigan ( Site 1217), Ann Arbor, Michigan, United States
Henry Ford Health System ( Site 1221), Detroit, Michigan, United States
Minnesota Oncology Hematology, PA ( Site 8001), Minneapolis, Minnesota, United States
Hattiesburg Clinic ( Site 1205), Hattiesburg, Mississippi, United States
Mercy Hospital Saint Louis ( Site 1213), Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada ( Site 8004), Henderson, Nevada, United States
Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226), Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225), Middletown, New Jersey, United States
Montefiore Einstein Center for Cancer Care - Main site ( Site 1204), Bronx, New York, United States
Montefiore Medical Center ( Site 1222), Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227), Commack, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1229), Harrison, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1211), New York, New York, United States
Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228), Rockville Centre, New York, United States
Duke University Medical Center ( Site 1214), Durham, North Carolina, United States
Bon Secours St. Francis Health Sytem ( Site 1212), Greenville, South Carolina, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230), Nashville, Tennessee, United States
Texas Oncology ( Site 8002), Austin, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003), Dallas, Texas, United States
Blacktown Hospital ( Site 0004), Blacktown, New South Wales, Australia
Southern Medical Day Care Centre ( Site 0001), Wollongong, New South Wales, Australia
St John of God ( Site 0006), Murdoch, Western Australia, Australia
Lyell McEwin Hospital ( Site 0002), Elizabeth Vale, , Australia
St Vincents Hospital Melbourne ( Site 0005), Fitzroy, , Australia
Cancer Care Manitoba ( Site 0159), Winnipeg, Manitoba, Canada
Nova Scotia Health Authority ( Site 0157), Halifax, Nova Scotia, Canada
William Osler Health System (Brampton Civic Hospital) ( Site 0161), Brampton, Ontario, Canada
Kingston Health Sciences Centre ( Site 0155), Kingston, Ontario, Canada
Sunnybrook Research Institute ( Site 0151), Toronto, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0152), Greenfield Park, Quebec, Canada
CISSS-CA Hotel Dieu de Levis ( Site 0154), Lévis, Quebec, Canada
CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158), Montreal, Quebec, Canada
St. Jerome Medical Research Inc. ( Site 0160), St-Jerome, Quebec, Canada
Instituto Nacional del Cancer ( Site 0207), Santiago, Region Metropolitana, Chile
Health and Care Chile ( Site 0202), Santiago, , Chile
Fundacion Arturo Lopez Perez FALP ( Site 0203), Santiago, , Chile
Pontificia Universidad Catolica de Chile ( Site 0206), Santiago, , Chile
Clinica Universidad Catolica del Maule ( Site 0208), Talca, , Chile
CHRU de Lille - Hopital Albert Calmette ( Site 0353), Lille, , France
C.H.R.U. De Limoges ( Site 0358), Limoges, , France
CHU Nantes - Hopital Laennec ( Site 0363), Nantes, , France
Centre Antoine Lacassagne ( Site 0362), Nice, , France
Hopital Tenon ( Site 0360), Paris, , France
Institut de Cancerologie Jean-Godinot ( Site 0351), Reims, , France
CHU de Toulouse - Hopital Larrey ( Site 0354), Toulouse, , France
Evangelische Lungenklinik Berlin ( Site 0403), Berlin, , Germany
Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411), Dresden, , Germany
Florence Nightingale Krankenhaus ( Site 0413), Duesseldorf, , Germany
SRH Waldklinikum Gera GmbH ( Site 0405), Gera, , Germany
Asklepios Klinikum Harburg ( Site 0412), Hamburg, , Germany
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401), Heidelberg, , Germany
Philipps-Universitat Marburg ( Site 0414), Marburg, , Germany
Universitaetsklinikum Tuebingen ( Site 0404), Tuebingen, , Germany
Orszagos Onkologiai Intezet ( Site 0453), Budapest, Pest, Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452), Budapest, , Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458), Budapest, , Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459), Budapest, , Hungary
Veszprem Megyei Tudogyogyintezet ( Site 0454), Farkasgyepu, , Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0460), Gyor, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456), Szekesfehervar, , Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451), Szolnok, , Hungary
Zala Megyei Szent Rafael Korhaz ( Site 0457), Zalaegerszeg, , Hungary
St Vincents University Hospital ( Site 1456), Dublin, , Ireland
St James Hospital ( Site 1452), Dublin, , Ireland
Soroka Medical Center ( Site 0505), Beer Sheva, , Israel
Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502), Haifa, , Israel
Meir Medical Center ( Site 0503), Kfar Saba, , Israel
Rabin Medical Center ( Site 0504), Petah Tikva, , Israel
Chaim Sheba Medical Center. ( Site 0501), Ramat-Gan, , Israel
National Hospital Organization Nagoya Medical Center ( Site 0615), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 0613), Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0614), Matsuyama, Ehime, Japan
Kurume University Hospital ( Site 0609), Kurume, Fukuoka, Japan
Hyogo Cancer Center ( Site 0611), Akashi, Hyogo, Japan
Kanagawa Cancer Center ( Site 0618), Yokohama, Kanagawa, Japan
Sendai Kousei Hospital ( Site 0602), Sendai, Miyagi, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608), Sakai, Osaka, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0607), Sunto-gun, Shizuoka, Japan
National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601), Ube, Yamaguchi, Japan
National Hospital Organization Kyushu Medical Center ( Site 0617), Fukuoka, , Japan
Hiroshima University Hospital ( Site 0604), Hiroshima, , Japan
Niigata Cancer Center Hospital ( Site 0610), Niigata, , Japan
Osaka International Cancer Institute ( Site 0616), Osaka, , Japan
The Cancer Institute Hospital of JFCR ( Site 0606), Tokyo, , Japan
Wakayama Medical University Hospital ( Site 0612), Wakayama, , Japan
Inje University Haeundae Paik Hospital ( Site 0905), Busan, , Korea, Republic of
National Cancer Center ( Site 0904), Goyang-si, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0903), Seoul, , Korea, Republic of
Asan Medical Center ( Site 0901), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0902), Seoul, , Korea, Republic of
Canterbury Regional Cancer & Blood Services ( Site 0701), Christchurch, , New Zealand
Mazowiecki Szpital Onkologiczny ( Site 0757), Wieliszew, Mazowieckie, Poland
Przychodnia Lekarska Komed ( Site 0769), Konin, , Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768), Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767), Lublin, , Poland
SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766), Poznan, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762), Poznan, , Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756), Torun, , Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751), Warszawa, , Poland
Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771), Wroclaw, , Poland
Belgorod Regional Oncology Dispensary ( Site 0804), Belgorod, , Russian Federation
N.N. Blokhin NMRCO ( Site 0801), Moscow, , Russian Federation
SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811), Pyatigorsk, , Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 0803), Saint Petersburg, , Russian Federation
Municipal Clinical Oncology Center ( Site 0802), Saint Petersburg, , Russian Federation
Hospital Universitario Insular de Gran Canaria ( Site 0952), Las Palmas de Gran Canaria, Gran Canaria, Spain
Complejo Hospitalario Universitario de A Coruna ( Site 0953), A Coruna, , Spain
Hospital del Mar ( Site 0956), Barcelona, , Spain
Hospital Universitari Vall d Hebron ( Site 0951), Barcelona, , Spain
Hospital Ciudad de Jaen ( Site 0957), Jaen, , Spain
Hospital General Universitario Gregorio Maranon ( Site 0958), Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz ( Site 0954), Madrid, , Spain
Hospital Clinico Universitario de Valencia ( Site 0955), Valencia, , Spain
Kantonsspital Graubuenden ( Site 1403), Chur, , Switzerland
CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405), Lausanne, , Switzerland
Universitaetsspital Zuerich ( Site 1404), Zuerich, , Switzerland
Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005), Kaohsiung, , Taiwan
China Medical University Hospital. ( Site 1003), Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 1007), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 1004), Tainan, , Taiwan
Chi Mei Medical Center Liuying ( Site 1006), Tainan, , Taiwan
National Taiwan University Hospital ( Site 1001), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 1002), Taipei, , Taiwan
Ege Universitesi Tıp Fakultesi ( Site 1052), Izmir, Bornova, Turkey
Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057), Adana, , Turkey
Ankara UTF ( Site 1055), Ankara, , Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060), Ankara, , Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053), Ankara, , Turkey
Trakya Uni. Tip Fakultesi ( Site 1063), Edirne, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058), Istanbul, , Turkey
Medipol Hastanesi ( Site 1066), Istanbul, , Turkey
Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064), Istanbul, , Turkey
Medical Park Izmir Hospital ( Site 1051), Izmir, , Turkey
Kocaeli Universitesi Tip Fakultesi ( Site 1061), Kocaeli, , Turkey
Inonu Universitesi Tip Fakultesi ( Site 1059), Malatya, , Turkey
Birmingham Heartlands Hospital ( Site 1162), Birmingham, , United Kingdom
St James s University Hospital ( Site 1161), Leeds, , United Kingdom
North Middlesex Hospital ( Site 1151), London, , United Kingdom
Maidstone Hospital ( Site 1155), Maidstone, , United Kingdom
Mount Vernon Cancer Centre ( Site 1156), Northwood, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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