Spots Global Cancer Trial Database for Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
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Trial Identification
Brief Title: Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
Official Title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)
Study ID: NCT03302234
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo. With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Cancer Center ( Site 0007), Phoenix, Arizona, United States
Disney Family Cancer Center ( Site 0035), Burbank, California, United States
Pacific Cancer Care ( Site 0001), Monterey, California, United States
John Wayne Cancer Institute ( Site 0021), Santa Monica, California, United States
Florida Hospital Cancer Institute ( Site 0009), Orlando, Florida, United States
Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018), Paducah, Kentucky, United States
New England Cancer Specialists ( Site 0019), Scarborough, Maine, United States
Boston Medical Center ( Site 0025), Boston, Massachusetts, United States
Lahey Hospital & Medical Center ( Site 0020), Burlington, Massachusetts, United States
Holy Name Medical Center ( Site 0022), Teaneck, New Jersey, United States
Icahn School of Medicine at Mount Sinai ( Site 0034), New York, New York, United States
The Ohio State University Wexner Medical Center ( Site 0016), Columbus, Ohio, United States
Mid Ohio Oncology/Hematology Inc. ( Site 0003), Columbus, Ohio, United States
Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031), Portland, Oregon, United States
Greenville Health System ( Site 8010), Greenville, South Carolina, United States
University of Tennessee Erlanger Oncology & Hematology ( Site 0026), Chattanooga, Tennessee, United States
Tennessee Cancer Specialists ( Site 0017), Knoxville, Tennessee, United States
Texas Oncology-Arlington South ( Site 8006), Arlington, Texas, United States
Texas Oncology-Methodist Dallas Cancer Center ( Site 8000), Dallas, Texas, United States
Texas Oncology-Flower Mound ( Site 8007), Flower Mound, Texas, United States
Texas Oncology-Longview Cancer Center ( Site 8009), Longview, Texas, United States
Northwest Cancer Specialists, P.C. ( Site 8001), Vancouver, Washington, United States
Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033), Yakima, Washington, United States
University of Wisconsin Carbone Cancer Center ( Site 0004), Madison, Wisconsin, United States
Medical College of Wisconsin Clinical Cancer Center ( Site 0027), Milwaukee, Wisconsin, United States
Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202), Viedma, Rio Negro, Argentina
Sanatorio Parque ( Site 0201), Rosario, Santa Fe, Argentina
Hospital Aleman ( Site 0208), Buenos Aires, , Argentina
Hospital Privado Centro Medico Cordoba ( Site 0206), Cordoba, , Argentina
Centro Oncologico Riojano Integral ( Site 0203), La Rioja, , Argentina
Sanatorio Britanico ( Site 0205), Rosario, , Argentina
Instituto de Oncologia de Rosario ( Site 0200), Rosario, , Argentina
Centro Medico San Roque ( Site 0207), Tucuman, , Argentina
Mater Cancer Care Centre ( Site 2102), South Brisbane, Queensland, Australia
Fiona Stanley Hospital ( Site 2105), Perth, Western Australia, Australia
Chris OBrien Lifehouse ( Site 2100), Camperdown, , Australia
The Townsville Hospital ( Site 2103), Douglas, , Australia
St Vincents Hospital Melbourne ( Site 2101), Fitzroy, , Australia
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0302), Recife, Pernambuco, Brazil
Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305), Santa Maria, Rio Grande Do Sul, Brazil
Hospital Nossa Senhora da Conceicao ( Site 0306), Porto Alegre, RS, Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 0300), Sao Paulo, SP, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0311), Sao Paulo, SP, Brazil
Escola Paulista de Medicina - UNIFESP ( Site 0304), Sao Paulo, SP, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312), Barretos, , Brazil
CEPON Centro de Pesquisa Oncológicas ( Site 0307), Florianopolis, , Brazil
Hospital do Servidor Publico do Estado ( Site 0308), Sao Paulo, , Brazil
Tom Baker Cancer Centre ( Site 0119), Calgary, Alberta, Canada
CancerCare Manitoba ( Site 0106), Winnipeg, Manitoba, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0115), Chicoutimi, Quebec, Canada
CISSS de la Monteregie-Centre ( Site 0100), Greenfield Park, Quebec, Canada
CISSS-CA Hotel-Dieu de Levis ( Site 0108), Levis, Quebec, Canada
CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107), Montreal, Quebec, Canada
St-Jerome Medical Research Inc ( Site 0113), St-Jerome, Quebec, Canada
Clinica Universidad Catolica del Maule ( Site 0413), Talca, El Maule, Chile
Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401), Santiago, , Chile
Pontificia Universidad Catolica de Chile ( Site 0404), Santiago, , Chile
Instituto Nacional del Cancer ( Site 0406), Santiago, , Chile
Hospital Clinico Vina del Mar ( Site 0400), Vina del Mar, , Chile
Hospital Pablo Tobon Uribe ( Site 0505), Medellin, Antioquia, Colombia
Centro de Investigacion Clinica del Country ( Site 0500), Bogota, , Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506), Bogota, , Colombia
Oncomedica S.A. ( Site 0502), Monteria, , Colombia
Instituto Cancerologico de Narino Ltda ( Site 0504), Pasto, , Colombia
Hopital Nord du Marseille ( Site 0808), Marseille, Cedex 20, France
Institut Bergonie ( Site 0803), Bordeaux, , France
CHU de Brest. Hopital Morvan ( Site 0800), Brest, , France
Centre Hopitalier Intercommunal Creteil ( Site 0802), Creteil, , France
Centre Hospitalier Le Mans ( Site 0804), Le Mans, , France
C.H.R.U de Lille - Hopital Calmette ( Site 0805), Lille, , France
Hopital Tenon ( Site 0810), Paris, , France
Nouvel Hopital Civil ( Site 0809), Strasbourg, , France
CHU de Toulouse - Hopital Larrey ( Site 0801), Toulouse, , France
Evangelische Lungenklinik Berlin ( Site 0903), Berlin, , Germany
Vivantes Klinikum Spandau ( Site 0910), Berlin, , Germany
HELIOS Klinikum Emil von Behring ( Site 0905), Berlin, , Germany
SRH Waldklinikum Gera GmbH ( Site 0907), Gera, , Germany
LungenClinic Grosshansdorf GmbH ( Site 0908), Grosshansdorf, , Germany
Universitaetsklinikum Heidelberg ( Site 0900), Heidelberg, , Germany
Universitaetsklinikum Leipzig ( Site 0919), Leipzig, , Germany
Universitaetsklinikum Schleswig Holstein. ( Site 0918), Luebeck, , Germany
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502), Budapest, , Hungary
Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506), Budapest, , Hungary
Orszagos Onkologiai Intezet ( Site 1509), Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1511), Debrecen, , Hungary
Veszprem Megyei Tudogyogyintezet ( Site 1503), Farkasgyepu, , Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1505), Gyor, , Hungary
Bekes Megyei Pandy Kalman Korhaz. ( Site 1507), Gyula, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504), Szekesfehervar, , Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501), Szolnok, , Hungary
Beaumont Hospital ( Site 1312), Dublin, , Ireland
St James Hospital ( Site 1401), Dublin, , Ireland
University Hospital Limerick ( Site 1403), Limerick, , Ireland
IRCCS Casa Sollievo della Sofferenza ( Site 1009), San Giovanni Rotondo (FG), Foggia, Italy
Humanitas Research Hospital ( Site 1004), Rozzano, Milano, Italy
Ospedale Mater Salutis ( Site 1005), Legnago, Verona, Italy
ASST Spedali Civili ( Site 1001), Brescia, , Italy
Istituto Europeo di Oncologia ( Site 1007), Milano, , Italy
Ospedale San Gerardo ASST Monza ( Site 1002), Monza, , Italy
AORN dei Colli Plesso Monaldi ( Site 1003), Napoli, , Italy
Ospedale Santa Maria della Misericordia ( Site 1008), Perugia, , Italy
Seoul National University Hospital ( Site 2303), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 2300), Seoul, , Korea, Republic of
Asan Medical Center ( Site 2302), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 2301), Seoul, , Korea, Republic of
Pauls Stradins Clinical University Hospital ( Site 1100), Riga, , Latvia
Riga East Clinical University Hospital ( Site 1111), Riga, , Latvia
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603), Guadalajara, Jalisco, Mexico
Avix Investigacion Clinica S.C. ( Site 0600), Monterrey, N.l., Mexico
Medical Care and Research S.A. de C.V. ( Site 0602), Merida, Yucatan, Mexico
Grupo Medico Camino SC ( Site 0607), Ciudad de Mexico, , Mexico
Medica Sur S.A.B de C.V. ( Site 0608), Mexico City, , Mexico
Oncologica de Puebla SA de CV ( Site 0606), Puebla, , Mexico
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705), La Victoria, Lima, Peru
Centro Especializado de Enfermedades Neoplasicas SRL-CEEN SRL ( Site 0710), Arequipa, , Peru
Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 0704), Arequipa, , Peru
Clinica Internacional Sede San Borja ( Site 0701), Lima, , Peru
Hospital Nacional Cayetano Heredia ( Site 0706), Lima, , Peru
Clinica Peruano Americana S.A. ( Site 0703), Trujillo, , Peru
Dolnoslaskie Centrum Onkologii. ( Site 1616), Wroclaw, Dolnoslaskie, Poland
Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614), Koszalin, Zachodniopomorskie, Poland
Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615), Brzeziny, , Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609), Bydgoszcz, , Poland
Przychodnia Lekarska Komed ( Site 1602), Konin, , Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607), Olsztyn, , Poland
MED-POLONIA Sp. z o.o. ( Site 1605), Poznan, , Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600), Warszawa, , Poland
Universitas Annex National Hospital ( Site 1800), Bloemfontein, Free State, South Africa
Clinton Onclogy Clinic ( Site 1804), Alberton, Gauteng, South Africa
Wilgers Oncology Centre ( Site 1808), Pretoria, Gauteng, South Africa
Vincent Pallotti Hospital ( Site 1811), Cape Town, , South Africa
University of Stellenbosch and Tygerberg Hospital ( Site 1810), Cape Town, , South Africa
Dr G.A. Landers Specialist Oncologist ( Site 1803), Durban, , South Africa
Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806), Johannesburg, , South Africa
Sandton Oncology Medical Group PTY LTD ( Site 1807), Johannesburg, , South Africa
GVI Oncology Clinical Research Centre ( Site 1802), Kraaifontein, , South Africa
Hospital Germans Trias i Pujol ( Site 1207), Badalona, Barcelona, Spain
Hospital Duran i Reynals ( Site 1201), Hospitalet de Llobregat, Barcelona, Spain
Hospital San Pedro de Alcantara ( Site 1208), Caceres, Extremadura, Spain
Hospital Universitario Insular de Gran Canaria ( Site 1203), Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Universitari Vall d Hebron ( Site 1211), Barcelona, , Spain
Hospital Fundacion Jimenez Diaz - Clin. Concepcion ( Site 1209), Madrid, , Spain
Hospital Universitario Virgen del Rocio ( Site 1200), Sevilla, , Spain
Changhua Christian Hospital ( Site 2406), Changhua, , Taiwan
Chang Gung Medical Foundation - Kaohsiung ( Site 2404), Kaohsiung, , Taiwan
China Medical University Hospital ( Site 2403), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 2401), Tainan, , Taiwan
National Taiwan University Hospital ( Site 2400), Taipei, , Taiwan
Mackay Memorial Hospital ( Site 2405), Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 2402), Taoyuan, , Taiwan
Ramathibodi Hospital. ( Site 2563), Ratchthevee, Bangkok, Thailand
Bangkok Hospital Chiangmai ( Site 2560), Mueang, Chiang Mai, Thailand
Chulalongkorn Hospital ( Site 2561), Bangkok, , Thailand
Pramongkutklao Hospital ( Site 2564), Bangkok, , Thailand
Siriraj Hospital ( Site 2562), Bangkok, , Thailand
Khon Kaen University ( Site 2565), Khon Kaen, , Thailand
Acibadem Adana Hastanesi ( Site 1904), Adana, , Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908), Ankara, , Turkey
Uludag Universitesi Tip Fakultesi ( Site 1914), Bursa, , Turkey
Ankara Sehir Hastanesi ( Site 1903), Cankaya - Ankara, , Turkey
Trakya Uni. Tip Fakultesi ( Site 1911), Edirne, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906), Istanbul, , Turkey
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912), Istanbul, , Turkey
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901), Izmir, , Turkey
Medical Park Izmir Hospital ( Site 1900), Izmir, , Turkey
Kocaeli Universitesi Tip Fakultesi ( Site 1909), Kocaeli, , Turkey
Inonu Universitesi Tip Fakultesi ( Site 1907), Malatya, , Turkey
Karadeniz Teknik Universitesi ( Site 1910), Trabzon, , Turkey
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005), Kryviy Rih, Dnipropetrovsk Region, Ukraine
Cherkasy Regional Hospital ( Site 2020), Cherkasy, , Ukraine
Regional Clinical Onco Dispensary_ State Medical University ( Site 2012), Chernivtsy, , Ukraine
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC ( Site 2000), Dnipropetrovsk, , Ukraine
MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009), Ivano-Frankivsk, , Ukraine
PP PPC Acinus Medical and Diagnostic Centre ( Site 2002), Kropyvnytskyi, , Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 2015), Kyiv, , Ukraine
Kyiv City Clinical Oncological Center ( Site 2014), Kyiv, , Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2003), Lviv, , Ukraine
MI Odessa Regional Oncological Centre ( Site 2004), Odesa, , Ukraine
Royal Cornwall Hospital ( Site 1325), Truro, Cornwall, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 1326), Sutton, Surrey, United Kingdom
Belfast City Hospital ( Site 1302), Belfast, , United Kingdom
Royal Free NHS Foundation Trust ( Site 1324), London, , United Kingdom
St. Georges University Hospital NHS Foundation Trust ( Site 1321), London, , United Kingdom
The Royal Marsden NHS Foundation Trust.. ( Site 1327), London, , United Kingdom
The Christie NHS Foundation Trust ( Site 1301), Manchester, , United Kingdom
Mount Vernon Cancer Centre ( Site 1307), Northwood, , United Kingdom
Royal Wolverhampton Hospitals NHS Trust ( Site 1323), Wolverhampton, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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