Spots Global Cancer Trial Database for Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
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Trial Identification
Brief Title: Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)
Study ID: NCT03635567
Conditions
Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Alaska Women's Cancer Care ( Site 1770), Anchorage, Alaska, United States
Arizona Oncology Associates, PC- HAL ( Site 8005), Phoenix, Arizona, United States
UC Irvine Health ( Site 1796), Orange, California, United States
Smilow Cancer Hospital at Yale New Haven ( Site 1809), New Haven, Connecticut, United States
H. Lee Moffitt Cancer Center and Research Institute ( Site 1754), Tampa, Florida, United States
Georgia Cancer Center at Augusta University ( Site 1767), Augusta, Georgia, United States
Barbara Ann Karmanos Cancer Institute ( Site 1785), Detroit, Michigan, United States
Henry Ford Health System ( Site 1810), Detroit, Michigan, United States
Washington University School of Medicine ( Site 1779), Saint Louis, Missouri, United States
Cancer Institute of New Jersey at University Hospital ( Site 1762), Newark, New Jersey, United States
Holy Name Medical Center ( Site 1776), Teaneck, New Jersey, United States
Mount Sinai Chelsea ( Site 1760), New York, New York, United States
Columbia University Medical Center ( Site 1800), New York, New York, United States
OSU Wexner Medical Center ( Site 1817), Hilliard, Ohio, United States
University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784), Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768), Tulsa, Oklahoma, United States
MUSC Hollings Cancer Center ( Site 1819), Charleston, South Carolina, United States
West Cancer Center - East Campus ( Site 1763), Germantown, Tennessee, United States
Texas Oncology-San Antonio Medical Center ( Site 8001), San Antonio, Texas, United States
Seattle Cancer Care Alliance ( Site 1777), Seattle, Washington, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006), Berazategui, Buenos Aires, Argentina
Hospital Aleman ( Site 1005), Buenos Aires, , Argentina
Hospital de Oncologia Angel Roffo ( Site 1003), Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming ( Site 1009), Buenos Aires, , Argentina
Centro Oncologico Riojano Integral ( Site 1004), La Rioja, , Argentina
Centro Medico San Roque ( Site 1001), Tucuman, , Argentina
Royal North Shore Hospital ( Site 1514), St Leonards, New South Wales, Australia
Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521), South Brisbane, Queensland, Australia
Flinders Medical Centre ( Site 1513), Bedford Park, South Australia, Australia
St John of God Subiaco Hospital ( Site 1512), Subiaco, Western Australia, Australia
Monash Health-Monash Medical Centre ( Site 1519), Clayton, , Australia
Tom Baker Cancer Centre ( Site 1728), Calgary, Alberta, Canada
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734), Kelowna, British Columbia, Canada
BC Cancer - Vancouver Center ( Site 1722), Vancouver, British Columbia, Canada
CancerCare Manitoba ( Site 1725), Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre ( Site 1731), Halifax, Nova Scotia, Canada
Juravinski Cancer Centre ( Site 1735), Hamilton, Ontario, Canada
London Regional Cancer Program - London HSC ( Site 1723), London, Ontario, Canada
The Ottawa Hospital Cancer Centre ( Site 1736), Ottawa, Ontario, Canada
Sunnybrook Research Institute ( Site 1733), Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 1732), Toronto, Ontario, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 1729), Chicoutimi, Quebec, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726), Montreal, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721), Montreal, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730), Sherbrooke, Quebec, Canada
CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724), Quebec, , Canada
Oncocentro ( Site 1065), Vina del Mar, Valparaiso, Chile
Fundacion Arturo Lopez Perez FALP ( Site 1061), Santiago, , Chile
Sociedad Oncovida S.A. ( Site 1069), Santiago, , Chile
Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063), Santiago, , Chile
Instituto Clinico Oncologico del Sur ( Site 1062), Temuco, , Chile
Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103), Valledupar, Cesar, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 1095), Bogota, Cundinamarca, Colombia
Hemato Oncologos S.A. ( Site 1100), Cali, Valle, Colombia
Biomelab S A S ( Site 1104), Barranquilla, , Colombia
Oncomedica S.A. ( Site 1098), Monteria, , Colombia
Instituto Cancerologico de Narino Ltda ( Site 1097), Pasto, , Colombia
Centre Jean Perrin ( Site 1181), Clermont Ferrand, , France
Institut Paoli Calmettes ( Site 1182), Marseille, , France
Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183), Paris, , France
Centre Eugene Marquis ( Site 1187), Rennes, , France
Institut Curie - Centre Rene Huguenin ( Site 1185), Saint-Cloud, , France
Universitaetsklinikum Carl Gustav Carus ( Site 1211), Dresden, , Germany
Universitaetsklinikum Duesseldorf ( Site 1220), Duesseldorf, , Germany
Universitatsklinikum Essen AoR ( Site 1213), Essen, , Germany
Universitatsklinikum Hamburg-Eppendorf ( Site 1212), Hamburg, , Germany
Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224), Hannover, , Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214), Kiel, , Germany
Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225), Muenchen, , Germany
Klinikum Oldenburg AoeR ( Site 1218), Oldenburg, , Germany
Universitaet Regensburg ( Site 1221), Regensburg, , Germany
Soroka Medical Center ( Site 1363), Beer-Sheva, , Israel
Rambam Medical Center ( Site 1364), Haifa, , Israel
Shaare Zedek Medical Center ( Site 1366), Jerusalem, , Israel
Hadassah Medical Center. Ein Kerem ( Site 1367), Jerusalem, , Israel
Rabin Medical Center ( Site 1365), Petah Tikva, , Israel
Chaim Sheba Medical Center ( Site 1361), Ramat Gan, , Israel
Sourasky Medical Center ( Site 1362), Tel Aviv, , Israel
Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243), Aviano, , Italy
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245), Bolgna, , Italy
Istituto Nazionale Tumori ( Site 1251), Milano, , Italy
Istituto Europeo di Oncologia ( Site 1250), Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242), Napoli, , Italy
Policlinico Universitario -Agostino Gemelli ( Site 1241), Roma, , Italy
The Jikei University Kashiwa Hospital ( Site 1701), Kashiwa, Chiba, Japan
National Cancer Center Hospital East ( Site 1704), Kashiwa, Chiba, Japan
Ehime University Hospital ( Site 1693), Toon, Ehime, Japan
Kurume University Hospital ( Site 1692), Kurume, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 1700), Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 1705), Akashi, Hyogo, Japan
Iwate Medical University Hospital ( Site 1695), Shiwa-gun, Iwate, Japan
University of the Ryukyus Hospital ( Site 1706), Nakagami-gun, Okinawa, Japan
Saitama Medical University International Medical Center ( Site 1691), Hidaka, Saitama, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 1703), Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 1702), Tokyo, , Japan
The Jikei University Hospital ( Site 1697), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 1698), Tokyo, , Japan
Keio University Hospital ( Site 1699), Tokyo, , Japan
Keimyung University Dongsan Medical Center ( Site 1603), Daegu, , Korea, Republic of
Seoul National University Hospital ( Site 1602), Seoul, , Korea, Republic of
Asan Medical Center ( Site 1601), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 1604), Seoul, , Korea, Republic of
Medical Care and Research S.A. de C.V. ( Site 1135), Merida, Yucatan, Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 1123), Chihuahua, , Mexico
Consultorio de Medicina Especializada del Sector Privado ( Site 1129), Ciudad de Mexico, , Mexico
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127), Ciudad de Mexico, , Mexico
Instituto Nacional de Cancerologia. ( Site 1130), Mexico, , Mexico
Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125), San Pedro Garza Garcia, , Mexico
Faicic S de RL de CV ( Site 1133), Veracruz, , Mexico
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152), Trujillo, La Libertad, Peru
Centro Medico Monte Carmelo ( Site 1156), Arequipa, , Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158), Lima, , Peru
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157), Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas ( Site 1153), Lima, , Peru
Hospital Nacional Arzobispo Loayza ( Site 1159), Lima, , Peru
Hospital Nacional Maria Auxiliadora ( Site 1155), Lima, , Peru
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331), Kazan, , Russian Federation
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334), Moscow, , Russian Federation
Medical Rehabilitation Center ( Site 1337), Moscow, , Russian Federation
Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358), Novosibirsk, , Russian Federation
Municipal Clinical Oncology Center ( Site 1346), Saint Petersburg, , Russian Federation
National Research Ogarev Mordovia State University ( Site 1347), Saransk, , Russian Federation
National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348), St. Petersburg, , Russian Federation
Tomsk Scientific Research Institute of Oncology ( Site 1360), Tomsk, , Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345), Ufa, , Russian Federation
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275), Doniostia - San Sebastian, Guipuzcoa, Spain
Hospital Quiron Madrid ( Site 1277), Pozuelo de Alarcon, Madrid, Spain
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276), Badalona, , Spain
MD Anderson Cancer Center Madrid ( Site 1273), Madrid, , Spain
Hospital Universitario Virgen Macarena ( Site 1274), Sevilla, , Spain
Kaohsiung Veterans General Hospital ( Site 1632), Kaohsiung, , Taiwan
China Medical University Hospital ( Site 1635), Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 1634), Taichung, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 1631), Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 1633), Taoyuan, , Taiwan
Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457), Adana, , Turkey
Hacettepe University Medical Faculty ( Site 1459), Ankara, , Turkey
Baskent Universitesi Ankara Hastanesi ( Site 1451), Ankara, , Turkey
Akdeniz Universitesi Tip Fakultesi ( Site 1453), Antalya, , Turkey
Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458), Istanbul, , Turkey
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456), Izmir, , Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452), Konya, , Turkey
City Clinical Hosp.4 of DCC ( Site 1482), Dnipropetrovsk, , Ukraine
MI Precarpathian Clinical Oncology Center ( Site 1487), Ivano-Frankivsk, , Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489), Kharkiv, , Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 1484), Kyiv, , Ukraine
MI Odessa Regional Oncological Centre ( Site 1493), Odesa, , Ukraine
Medical Centre LLC Oncolife ( Site 1485), Zaporizhzhya, , Ukraine
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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