Spots Global Cancer Trial Database for A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
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Trial Identification
Brief Title: A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
Official Title: A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT03976362
Study Description
Brief Summary: The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
Detailed Description: This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance olaparib placebo. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance olaparib placebo until centrally verified progressive disease (PD), intolerable toxicities, or physician decision. As of Amendment 07, participants actively taking placebo will discontinue taking the placebo intervention and continue in the study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alabama Oncology Bruno Cancer Center ( Site 0001), Birmingham, Alabama, United States
Disney Family Cancer Center ( Site 0005), Burbank, California, United States
Boca Raton Regional Hospital ( Site 0018), Boca Raton, Florida, United States
Mid-Florida Cancer Centers ( Site 0022), Orange City, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute ( Site 0024), Tampa, Florida, United States
Columbus Regional Research Institute ( Site 0099), Columbus, Georgia, United States
Mount Sinai Hospital Medical Center ( Site 0035), Chicago, Illinois, United States
Oncology of Northshore ( Site 0036), Rolling Meadows, Illinois, United States
Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039), Merrillville, Indiana, United States
MedStar Franklin Square Medical Center ( Site 0044), Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute ( Site 0046), Detroit, Michigan, United States
Hattiesburg Clinic ( Site 0051), Hattiesburg, Mississippi, United States
Frontier Oncology ( Site 0052), Billings, Montana, United States
Bozeman Health Deaconness Cancer Center ( Site 0053), Bozeman, Montana, United States
Waverly Hematology Oncology ( Site 0054), Cary, North Carolina, United States
Thompson Cancer Survival Center ( Site 2812), Knoxville, Tennessee, United States
Renovatio Clinical ( Site 0074), The Woodlands, Texas, United States
Cancer Care Northwest ( Site 0083), Spokane Valley, Washington, United States
Hospital Italiano Regional del Sur ( Site 0509), Bahia Blanca, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516), Mar del Plata, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires ( Site 0500), Buenos Aires, Caba, Argentina
Instituto Medico Rio Cuarto ( Site 0501), Rio Cuarto, Cordoba, Argentina
Sanatorio Parque ( Site 0515), Rosario, Santa Fe, Argentina
Centro Oncológico de Rosario ( Site 0507), Rosario, Santa Fe, Argentina
Centro Medico San Roque ( Site 0506), San Miguel de Tucuman, Tucuman, Argentina
Hospital Italiano de Buenos Aires ( Site 0511), Buenos Aires, , Argentina
Clínica Universitaria Reina Fabiola ( Site 0505), Cordoba, , Argentina
Sanatorio Privado San Geronimo S.R.L ( Site 0510), Santa Fe, , Argentina
Liverpool Hospital ( Site 1201), Liverpool, New South Wales, Australia
Southern Medical Day Care Centre ( Site 1200), Wollongong, New South Wales, Australia
Townsville General Hospital ( Site 1202), Townsville, Queensland, Australia
Monash Cancer Centre ( Site 1205), Clayton, Victoria, Australia
Ordensklinikum Linz GmbH Elisabethinen ( Site 1307), Linz, Oberosterreich, Austria
Klinikum Wels-Grieskirchen ( Site 1304), Wels, Oberosterreich, Austria
Innsbruck LKH ( Site 1302), Innsbruck, Tirol, Austria
Social Medical Center - Otto Wagner Hospital ( Site 1301), Vienna, Wien, Austria
Krankenhaus Nord - Klinik Floridsdorf ( Site 1300), Wien, , Austria
Hospital Sao Rafael ( Site 0258), Salvador - BA, Bahia, Brazil
Instituto do Cancer do Ceara ( Site 0251), Fortaleza, Ceara, Brazil
Oncologica do Brasil ( Site 0256), Belem, Para, Brazil
Hospital Tacchini ( Site 0265), Bento Goncalves, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255), Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252), Itajai, Santa Catarina, Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 0254), Sao Jose Rio Preto, Sao Paulo, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253), Rio de Janeiro, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250), Sao Paulo, , Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0263), Sao Paulo, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260), Sao Paulo, , Brazil
Nova Scotia Health Authority ( Site 0103), Halifax, Nova Scotia, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107), Hamilton, Ontario, Canada
Kingston Health Sciences Centre ( Site 0102), Kingston, Ontario, Canada
Stronach Regional Cancer Centre ( Site 0100), Newmarket, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0101), Greenfield Park, Quebec, Canada
Hopital Cite de la Sante de Laval ( Site 0105), Laval, Quebec, Canada
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110), Montreal, Quebec, Canada
CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106), Trois-Rivieres, Quebec, Canada
Centre Hospitalier De Chauny ( Site 1411), Chauny, Aisne, France
CHU Caen ( Site 1406), Caen, Calvados, France
CHU Angers ( Site 1405), Angers, Maine-et-Loire, France
Institut De Cancerologie De Lorraine ( Site 1409), Vandoeuvre les Nancy, Meurthe-et-Moselle, France
Hopital Robert Schuman ( Site 1402), Vantoux, Moselle, France
Centre Jean Perrin ( Site 1407), Clermont Ferrand, Puy-de-Dome, France
Centre Hospitalier de Pau ( Site 1412), Pau, Pyrenees-Atlantiques, France
CHU de Rouen ( Site 1403), Rouen, Seine-Maritime, France
Hopital d'Instruction des Armees Begin ( Site 1413), Saint-Mande, Val-de-Marne, France
Studienzentrum Aschaffenburg ( Site 1575), Aschaffenburg, Bayern, Germany
Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573), Muenchen, Bayern, Germany
Klinikum der LMU ( Site 1550), Munich, Bayern, Germany
Universitaetsklinikum Regensburg ( Site 1562), Regensburg, Bayern, Germany
Klinikum Wuerzburg Mitte gGmbH ( Site 1559), Wuerzburg, Bayern, Germany
Universitaetsklinikum Frankfurt ( Site 1563), Frankfurt, Hessen, Germany
Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551), Immenhausen, Hessen, Germany
Universitaetsmedizin Goettingen ( Site 1557), Goettingen, Niedersachsen, Germany
Universitaetsklinikum Bonn ( Site 1574), Bonn, Nordrhein-Westfalen, Germany
Kliniken Essen Mitte ( Site 1567), Essen, Nordrhein-Westfalen, Germany
InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564), Koblenz, Rheinland-Pfalz, Germany
Helios Klinikum Erfurt GmbH ( Site 1552), Erfurt, Thuringen, Germany
Katholisches Marienkrankenhaus gGmbH ( Site 1572), Hamburg, , Germany
National Hospital Organization Nagoya Medical Center ( Site 0806), Nagoya, Aichi, Japan
Aichi Cancer Center Hospital ( Site 0803), Nagoya, Aichi, Japan
National Cancer Center Hospital East ( Site 0801), Kashiwa, Chiba, Japan
Kurume University Hospital ( Site 0814), Kurume, Fukuoka, Japan
Kanazawa University Hospital ( Site 0811), Kanazawa, Ishikawa, Japan
Kanagawa Cancer Center ( Site 0807), Yokohama, Kanagawa, Japan
Sendai Kousei Hospital ( Site 0812), Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 0804), Hirakata, Osaka, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813), Sakai, Osaka, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0802), Sunto-gun, Shizuoka, Japan
National Hospital Organization Kyushu Medical Center ( Site 0805), Fukuoka, , Japan
Niigata Cancer Center Hospital ( Site 0808), Niigata, , Japan
Okayama University Hospital ( Site 0810), Okayama, , Japan
Osaka International Cancer Institute ( Site 0809), Osaka, , Japan
The Cancer Institute Hospital of JFCR ( Site 0800), Tokyo, , Japan
Chungbuk National University Hospital ( Site 1002), Cheongju si, Chungbuk, Korea, Republic of
National Cancer Center ( Site 1006), Goyang-si, Kyonggi-do, Korea, Republic of
The Catholic University of Korea St. Vincent s Hospital ( Site 1003), Gyeonggi-do, Kyonggi-do, Korea, Republic of
Ajou University Hospital ( Site 1004), Suwon, Kyonggi-do, Korea, Republic of
Gyeongsang National University Hospital ( Site 1005), Jinju, Kyongsangnam-do, Korea, Republic of
Asan Medical Center ( Site 1007), Songpa-gu, Seoul, Korea, Republic of
Seoul National University Hospital ( Site 1000), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1001), Seoul, , Korea, Republic of
Korea University Guro Hospital ( Site 1008), Seoul, , Korea, Republic of
Investigacion Onco Farmaceutica S de RL de CV ( Site 0300), La Paz, Baja California Sur, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334), Guadalajara, Jalisco, Mexico
Axis Heilsa S. de R.L. de C.V. ( Site 0301), Monterrey, Nuevo Leon, Mexico
CLIMERS Clinical Medical Research ( Site 0306), Orizaba, Veracruz, Mexico
Arke Estudios Clinicos ( Site 0333), Cdmx, , Mexico
FAICIC Clinical Research ( Site 0303), Veracruz, , Mexico
MidCentral DHB Palmerston North Hospital ( Site 1102), Palmerston North, Manawatu-Wanganui, New Zealand
Capital & Coast District Health Board - Wellington Hospital ( Site 1101), Wellington, , New Zealand
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417), Olsztyn, Dolnoslaskie, Poland
Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404), Zgorzelec, Dolnoslaskie, Poland
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420), Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (, Warszawa, Mazowieckie, Poland
Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402), Raciborz, Slaskie, Poland
Przychodnia Lekarska Komed ( Site 2416), Konin, Wielkopolskie, Poland
MED-POLONIA Sp. z o.o. ( Site 2419), Poznan, Wielkopolskie, Poland
Cardiomed SRL Cluj-Napoca ( Site 2504), Cluj Napoca, Cluj, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 2507), Cluj-Napoca, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508), Craiova, Dolj, Romania
Policlinica Oncomed SRL ( Site 2505), Timisoara, Timis, Romania
S.C.Focus Lab Plus S.R.L ( Site 2502), Bucuresti, , Romania
Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501), Constanta, , Romania
Moscow Regional Oncological Dispensary ( Site 2028), Balashikha, Moskovskaya Oblast, Russian Federation
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000), Moscow, Moskva, Russian Federation
First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024), Moscow, Moskva, Russian Federation
Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009), Moscow, Moskva, Russian Federation
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006), Moscow, Moskva, Russian Federation
Nizhniy Novgorod Region Oncology Dispensary ( Site 2026), Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site, Omsk, Omskaya Oblast, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016), Samara, Samarskaya Oblast, Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 2002), Saint Petersburg, Sankt-Peterburg, Russian Federation
SPb Central Clinical Railway Hospital ( Site 2003), Saint Petersburg, Sankt-Peterburg, Russian Federation
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004), Saint Petersburg, Sankt-Peterburg, Russian Federation
SPb SBHI City Clinical Oncological Dispensary ( Site 2001), Saint Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021), Kazan, Tatarstan, Respublika, Russian Federation
Hospital Duran i Reynals ( Site 1710), Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario de Jaen ( Site 1713), Jaen, La Coruna, Spain
Hospital Sant Creu i Sant Pau ( Site 1711), Barcelona, , Spain
Hospital Universitario 12 de Octubre ( Site 1716), Madrid, , Spain
Complejo Hospitalario de Malaga ( Site 1714), Malaga, , Spain
Hospital Universitario Virgen Macarena ( Site 1712), Sevilla, , Spain
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907), Kaohsiung, , Taiwan
China Medical University Hospital ( Site 0904), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0905), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0900), Taipei, , Taiwan
Mackay Memorial Hospital ( Site 0902), Taipei, , Taiwan
Chang Gung Medical Foundation.Linkou Branch ( Site 0903), Taoyuan, , Taiwan
Namik Kemal Universitesi Tip Fakultesi ( Site 2100), Tekirdag, Tekirdas, Turkey
Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101), Adana, , Turkey
Gazi Universitesi Tip Fakultesi ( Site 2104), Ankara, , Turkey
Ankara Sehir Hastanesi ( Site 2105), Ankara, , Turkey
Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107), Istanbul, , Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103), Istanbul, , Turkey
Ege Universitesi Tip Fakultesi ( Site 2109), Izmir, , Turkey
Erciyes Universitesi Tip Fakultesi ( Site 2108), Kayseri, , Turkey
Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106), Samsun, , Turkey
Cherkasy Regional Oncology Dispensary ( Site 2225), Cherkasy, Cherkaska Oblast, Ukraine
City Clinical Hosp.4 of DCC ( Site 2215), Dnipro, Dnipropetrovska Oblast, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 2218), Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226), Kharkiv, Kharkivska Oblast, Ukraine
Regional Centre of Oncology-Thoracic organs ( Site 2219), Kharkiv, Kharkivska Oblast, Ukraine
PP PPC Acinus Medical and Diagnostic Centre ( Site 2223), Kropyvnytskyi, Kirovohradska Oblast, Ukraine
Medical Center Asklepion LLC ( Site 2243), Khodosivka, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 2224), Kyiv, Kyivska Oblast, Ukraine
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227), Kyiv, Kyivska Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 2222), Odesa, Odeska Oblast, Ukraine
Central City Clinical Hospital ( Site 2221), Uzhgorod, Zakarpatska Oblast, Ukraine
Medical Center Verum ( Site 2228), Kyiv, , Ukraine
Southend University Hospital NHS Foundation Trust ( Site 1913), Westcliff-on-Sea, Essex, United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923), London, London, City Of, United Kingdom
Chelsea and Westminster Hospital ( Site 1901), London, London, City Of, United Kingdom
Newcastle Freeman Hospital ( Site 1902), Newcastle-upon-Tyne, Newcastle Upon Tyne, United Kingdom
West Suffolk Hospitals NHS Trust ( Site 1919), Bury Saint Edmunds, Suffolk, United Kingdom
Singleton Hospital ( Site 1909), Swansea, Wales, United Kingdom
Colchester General Hospital ( Site 1911), Colchester, Worcestershire, United Kingdom
Birmingham Heartlands Hospital ( Site 1910), Birmingham, , United Kingdom
Western General Hospital, Edinburgh ( Site 1924), Edinburg, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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