Lung Cancer Clinical Trial
Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)
Summary
This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.
Eligibility Criteria
Inclusion Criteria:
Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy
Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Has a predicted life expectancy of >3 months
Exclusion Criteria:
Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
Has received prior treatment for Small Cell Lung Cancer (SCLC)
Is expected to require any other form of antineoplastic therapy for SCLC while on study
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has a known history of, or active, neurologic paraneoplastic syndrome
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has had an allogenic tissue/solid organ transplant
Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
Has symptomatic ascites or pleural effusion
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There are 138 Locations for this study
Mobile Alabama, 36652, United States
Los Angeles California, 90017, United States
Los Angeles California, 90073, United States
Boca Raton Florida, 33486, United States
Fort Wayne Indiana, 46804, United States
Boston Massachusetts, 02215, United States
Grand Rapids Michigan, 49503, United States
Hattiesburg Mississippi, 39401, United States
Lancaster Pennsylvania, 17601, United States
Blacksburg Virginia, 24060, United States
Charlottesville Virginia, 22903, United States
Mar del Plata Buenos Aires, 7600, Argentina
ABB Caba, C1199, Argentina
Buenos Aires Caba, C1431, Argentina
Rosario Santa Fe, 2000, Argentina
Rosario Santa Fe, 2002, Argentina
Penrith New South Wales, 2747, Australia
Waratah New South Wales, 2298, Australia
Frankston Victoria, 3199, Australia
St Albans Victoria, 3021, Australia
Linz Oberosterreich, 4020, Austria
Linz Oberosterreich, 4021, Austria
Graz Steiermark, 8036, Austria
Vienna Wien, 1140, Austria
Wien , 1210, Austria
Kingston Ontario, K7L 2, Canada
Oshawa Ontario, L1G 2, Canada
Hefei Anhui, 23003, China
Beijing Beijing, 10014, China
Beijing Beijing, 10073, China
Fuzhou Fujian, 35001, China
Harbin Heilongjiang, 15008, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41001, China
Suzhou Jiangsu, 21500, China
Changchun Jilin, 13000, China
Changchun Jilin, 13002, China
Xi'an Shaanxi, 71006, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20003, China
Chengdu Sichuan, 61004, China
Chengdu Sichuan, 61113, China
Hangzhou Zhejiang, 31001, China
Hangzhou Zhejiang, 31002, China
Vaasa Pohjanmaa, 65130, Finland
Oulu Pohjois-Pohjanmaa, 90220, Finland
Turku Varsinais-Suomi, 20521, Finland
Marseille Bouches-du-Rhone, 13915, France
Toulouse Haute-Garonne, 31059, France
Limoges Haute-Vienne, 87042, France
Heidelberg Baden-Wurttemberg, 69126, Germany
Immenhausen Hessen, 34376, Germany
Hannover Niedersachsen, 30625, Germany
Grosshansdorf Schleswig-Holstein, 22927, Germany
Gera Thuringen, 07548, Germany
Athens Attiki, 115 2, Greece
Athens Attiki, 11527, Greece
Athens Attiki, 185 4, Greece
Heraklion Irakleio, 711 1, Greece
Thessaloniki , 570 0, Greece
Kecskemét Bacs-Kiskun, 6000, Hungary
Gyor Gyor-Moson-Sopron, 9024, Hungary
Törökbálint Pest, 2045, Hungary
Kaposvár Somogy, 7400, Hungary
Dublin , D08 E, Ireland
Dublin , Dubli, Ireland
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Ramat Gan , 52656, Israel
Naples Campania, 80131, Italy
Milan Lombardia, 20133, Italy
Rozzano Milano, 20089, Italy
Rome Roma, 00144, Italy
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 277-8, Japan
Matsuyama Ehime, 791-0, Japan
Kurume Fukuoka, 830-0, Japan
Sapporo Hokkaido, 003-0, Japan
Kanazawa Ishikawa, 920-8, Japan
Yokohama Kanagawa, 241-8, Japan
Sendai Miyagi, 98008, Japan
Niigata-shi Niigata, 951-8, Japan
Hirakata Osaka, 573-1, Japan
Nagaizumi Shizuoka, 411-8, Japan
Koto Tokyo, 135-8, Japan
Fukuoka , 810-8, Japan
Okayama , 700-8, Japan
Hwasun Jeonranamdo, 58128, Korea, Republic of
Deagu Taegu-Kwangyokshi, 41404, Korea, Republic of
Daejeon Taejon-Kwangyokshi, 35015, Korea, Republic of
Seoul , , Korea, Republic of
Klaipeda Klaipedos Miestas, 92288, Lithuania
Vilnius Vilniaus Miestas, 08406, Lithuania
Kaunas , LT-50, Lithuania
Mexico Distrito Federal, 06700, Mexico
Guadalajara Jalisco, 44280, Mexico
Guadalajara Jalisco, 44680, Mexico
Monterrey Nuevo Leon, 64710, Mexico
Oaxaca , 68020, Mexico
Leeuwarden Fryslan, 8934 , Netherlands
Arnhem Gelderland, 6815 , Netherlands
Maastricht Limburg, 6229 , Netherlands
Den Bosch Noord-Brabant, 5223 , Netherlands
Zwolle Overijssel, 8025 , Netherlands
Rotterdam Zuid-Holland, 3015 , Netherlands
Groningen , 9728 , Netherlands
Siedlce Mazowieckie, 08-11, Poland
Warszawa Mazowieckie, 02-78, Poland
Przemysl Podkarpackie, 37-70, Poland
Prabuty Pomorskie, 82-55, Poland
Bystra Slaskie, 43-36, Poland
Konin Wielkopolskie, 62-50, Poland
Poznan Wielkopolskie, 60-69, Poland
Lisbon Lisboa, 1400-, Portugal
Lisbon Lisboa, 1998-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
București Bucuresti, 02234, Romania
București Bucuresti, 02254, Romania
Cluj-Napoca Cluj, 40001, Romania
Craiova Dolj, 20038, Romania
Craiova Dolj, 20074, Romania
Timișoara Timis, 30023, Romania
Madrid Madrid, Comunidad De, 28041, Spain
Málaga Malaga, 29011, Spain
Barcelona , 08035, Spain
Sevilla , 41009, Spain
Bornova Izmir, 35100, Turkey
Izmir, Karsiyaka Izmir, 00903, Turkey
Adana , 01250, Turkey
Ankara , 06230, Turkey
Ankara , 06520, Turkey
Ankara , 06800, Turkey
Istanbul , 34214, Turkey
Istanbul , 34722, Turkey
Manchester England, M20 4, United Kingdom
Northwood Hillingdon, HA6 2, United Kingdom
Birmingham , B9 5S, United Kingdom
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