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Brief Title: Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)
Official Title: A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)
Study ID: NCT04924101
Brief Summary: The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center ( Site 0102), Gilbert, Arizona, United States
University of Colorado Anschutz Medical Campus ( Site 0104), Aurora, Colorado, United States
Georgia Cancer Specialists ( Site 0106), Atlanta, Georgia, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0130), Fort Wayne, Indiana, United States
Baptist Health Lexington-Research ( Site 0108), Lexington, Kentucky, United States
MFSMC-HJWCI-Oncology Research ( Site 0128), Baltimore, Maryland, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0122), Omaha, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0129), Omaha, Nebraska, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0114), Mineola, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0115), New York, New York, United States
Cleveland Clinic-Taussig Cancer Center ( Site 0116), Cleveland, Ohio, United States
UPMC Hillman Cancer Center ( Site 0127), Pittsburgh, Pennsylvania, United States
St Francis Cancer Center-Research Office ( Site 0117), Greenville, South Carolina, United States
Virginia Cancer Institute ( Site 0119), Richmond, Virginia, United States
Klinik Penzing-2. Lungenabteilung ( Site 2101), Vienna, Wien, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2100), Wien, , Austria
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2003), Hamilton, Ontario, Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2005), Kingston, Ontario, Canada
St. Marys Hospital Center ( Site 2000), Montreal, Quebec, Canada
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2800), Szolnok, Jasz-Nagykun-Szolnok, Hungary
Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 2806), Budapest, Pest, Hungary
Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 2801), Törökbálint, Pest, Hungary
Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 2805), Zalaegerszeg, Zala, Hungary
Semmelweis University-Pulmonológiai Klinika ( Site 2802), Budapest, , Hungary
Rambam Health Care Campus-Oncology ( Site 2600), Haifa, , Israel
Shaare Zedek Medical Center ( Site 2602), Jerusalem, , Israel
Meir Medical Center ( Site 2601), Kfar Saba, , Israel
Rabin Medical Center-Oncology ( Site 2604), Petah Tikva, , Israel
Sheba Medical Center-ONCOLOGY ( Site 2603), Ramat Gan, , Israel
Ospedale San Raffaele-Oncologia Medica ( Site 2303), Milano, Lombardia, Italy
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 2300), Siena, Toscana, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 2304), Milano, , Italy
Chungbuk National University Hospital ( Site 1107), Cheongju-si, Chungbuk, Korea, Republic of
Seoul National University Bundang Hospital ( Site 1104), Seongnam, Kyonggi-do, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital ( Site 1106), Suwon-si, Kyonggi-do, Korea, Republic of
Seoul National University Hospital ( Site 1101), Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1105), Seoul, , Korea, Republic of
Asan Medical Center-Department of Oncology ( Site 1103), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 1100), Seoul, , Korea, Republic of
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier, Warszawa, Mazowieckie, Poland
Samodzielny Publiczny Zespó Grulicy i Chorób Puc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemi, Olsztyn, Warminsko-mazurskie, Poland
Krasnoyarsk Regional Oncology Dispensary, Named after Krizhanovsky ( Site 2708), Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S, Saint Petersburg, Sankt-Peterburg, Russian Federation
GBUZ "SPb CRPCstmc(o)" ( Site 2705), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 2704), Sankt-Peterburg, , Russian Federation
Instituto Catalan de Oncologia - Hospital Duran i Reynals ( Site 2403), L'Hospitalet de Llobregat, Cataluna, Spain
Hospital Insular de Gran Canaria ( Site 2402), Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 2401), Barcelona, , Spain
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 2502), st.Gallen, Sankt Gallen, Switzerland
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR