Клинические исследование Новообразования головы и шеи: Pembrolizumab 200 mg, Лучевая терапия 60 Грей / день, Лучевая терапия 66 Грей / день, Лучевая терапия 70 Грей / день, Цисплатин 100 мг / м ^ 2

Спонсоры	Ведущий спонсор: Merck Sharp & Dohme Corp.
Источник	Merck Sharp & Dohme Corp.
Краткое содержание	Это рандомизированное, активно контролируемое открытое исследование пембролизумаба (Пембро) с учетом до операции и пембролизума в комбинации со стандартной лучевой терапией (с или без цисплатина), в качестве послеоперационной терапии у ранее не получавших лечения участников с недавно диагностированная стадия III / IVA, операбельная, локально-регионарно-языковая, плоскоклеточная распространка головы и шеи карцинома (LA-HNSCC). Результаты эффективности стратифицированы лигандом запрограммированной гибели клеток 1. (PD-L1) статусной комбинированной положительной оценки (CPS). Основная гипотеза заключается в том, что пембролизумаб перед операцией и после операции в сочетании с лучевой терапией (с или без цисплатин) улучшает основной патологический ответ и выживаемость без событий по сравнению с лучевая терапия (с цисплатином или без него), проводимая только после операции.

Общий статус

Рекрутинг

Дата начала

2018-12-17

Дата завершения

2026-07-30

Дата первичного завершения

2025-07-30

Фаза

Фаза 3

Тип исследования

Интервенционный

Первичный результат

Мера	Временное ограничение
Major Pathological Response (mPR)	Up to 30 days post-sugery
gamle biler	До 5 лет

Вторичный результат

Мера	Временное ограничение
Overall Survival (OS)	Up to 5 years
gamle biler	gamle biler
gamle biler	gamle biler
gamle biler	gamle biler
gamle biler	gamle biler
gamle biler	gamle biler
gamle biler	gamle biler

Регистрация

704

Состояние	Новообразования головы и шеи
Вмешательство	Тип вмешательства: Biological Название вмешательства: Pembrolizumab 200 mg Описание: 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle Этикетка Arm Group: Pembro Neoadjuvant+Pembro SOC Adjuvant Тип вмешательства: Радиация Название вмешательства: Лучевая терапия 60 Грей / день Описание: Участникам с низким уровнем риска вводили 2 грей / день в 30 фракциях. Применяется с использованием лучевой терапии с модуляцией. Тип вмешательства: Радиация Название вмешательства: Лучевая терапия 66 Грей / день Описание: Участникам высокого риска вводили 2 грей / день в 33 фракциях. Применяется с использованием лучевой терапии с модуляцией. Тип вмешательства: Радиация Название вмешательства: Лучевая терапия 70 Грей / день Описание: Участникам с грубым остаточным заболеванием вводили 2 грей / день в 35 фракциях. Применяется с использованием лучевой терапии с модуляцией. Тип вмешательства: Лекарство Название вмешательства: Цисплатин 100 мг / м ^ 2 Описание: 100 мг / м ^ 2 вводят внутривенно в день 1 каждого 21-дневного цикла
Приемлемость	Критерии: gamle biler gamle biler Пол: Все Минимальный возраст: 18 лет Максимальный возраст: N / A Здоровые волонтеры: Нет

Состояние

Новообразования головы и шеи

Вмешательство

Тип вмешательства: Biological

Название вмешательства: Pembrolizumab 200 mg

Описание: 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Этикетка Arm Group: Pembro Neoadjuvant+Pembro SOC Adjuvant

Тип вмешательства: Радиация

Название вмешательства: Лучевая терапия 60 Грей / день

Описание: Участникам с низким уровнем риска вводили 2 грей / день в 30 фракциях. Применяется с использованием лучевой терапии с модуляцией.

Тип вмешательства: Радиация

Название вмешательства: Лучевая терапия 66 Грей / день

Описание: Участникам высокого риска вводили 2 грей / день в 33 фракциях. Применяется с использованием лучевой терапии с модуляцией.

Тип вмешательства: Радиация

Название вмешательства: Лучевая терапия 70 Грей / день

Описание: Участникам с грубым остаточным заболеванием вводили 2 грей / день в 35 фракциях. Применяется с использованием лучевой терапии с модуляцией.

Тип вмешательства: Лекарство

Название вмешательства: Цисплатин 100 мг / м ^ 2

Описание: 100 мг / м ^ 2 вводят внутривенно в день 1 каждого 21-дневного цикла

Приемлемость

Критерии:

gamle biler gamle biler

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

N / A

Здоровые волонтеры:

Нет

Общий Официальный

Фамилия	Роль	Присоединение
Medical Director	Study Director	Merck Sharp & Dohme Corp.

Общий контакт

Фамилия: Toll Free Number

Телефон: 1-888-577-8839

Расположение

Объект:	Положение дел:	Контакт:
Moores Cancer Center ( Site 1885) \| La Jolla, California, 92093-0698, United States	Recruiting	Study Coordinator 858-534-6161
University of Southern California Norris Comprehensive Cancer Center ( Site 1850) \| Los Angeles, California, 90033, United States	Completed
UC Davis Health System ( Site 1864) \| Sacramento, California, 95817, United States	Recruiting	Study Coordinator 916-734-8452
St. Joseph Heritage Healthcare ( Site 1806) \| Santa Rosa, California, 95403, United States	Recruiting	Study Coordinator 707-521-3836
University of Colorado Cancer Center ( Site 1838) \| Aurora, Colorado, 80045, United States	Recruiting	Study Coordinator 720-848-0702
George Washington University Medical Faculty Associates ( Site 2035) \| Washington, District of Columbia, 20037, United States	Completed
University of Florida ( Site 1832) \| Gainesville, Florida, 32610, United States	Completed
University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008) \| Miami, Florida, 33136, United States	Completed
Saint Alphonsus Regional Medical Center ( Site 2021) \| Boise, Idaho, 83706, United States	Completed
Rush University Medical Center ( Site 1823) \| Chicago, Illinois, 60612, United States	Recruiting	Study Coordinator 312-942-8004
NorthShore University HealthSystem ( Site 1812) \| Evanston, Illinois, 60201, United States	Recruiting	Study Coordinator 847-570-2109
Loyola University Medical Center [Maywood, IL] ( Site 1817) \| Maywood, Illinois, 60153, United States	Recruiting	Study Coordinator 708-327-3236
University of Kansas Cancer Center ( Site 2004) \| Westwood, Kansas, 66205, United States	Recruiting	Study Coordinator 913-588-6029
Ochsner Cancer Institute ( Site 2045) \| New Orleans, Louisiana, 70121, United States	Recruiting	Study Coordinator 504-703-3269
University of Maryland ( Site 2031) \| Baltimore, Maryland, 21201, United States	Recruiting	Study Coordinator 410-328-6373
Dana Farber Cancer Center ( Site 1873) \| Boston, Massachusetts, 02215, United States	Recruiting	Study Coordinator 617-582-9571
University of Massachusetts Memorial Medical Center ( Site 1875) \| Worcester, Massachusetts, 01655, United States	Completed
Karmanos Cancer Institute ( Site 1870) \| Detroit, Michigan, 48201, United States	Recruiting	Study Coordinator 313-576-8994
Henry Ford Health System ( Site 1803) \| Detroit, Michigan, 48202, United States	Recruiting	Study Coordinator 313-916-1049
Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016) \| Edina, Minnesota, 55435, United States	Recruiting	Study Coordinator 612-672-5233
Washington University School of Medicine ( Site 1800) \| Saint Louis, Missouri, 63110, United States	Recruiting	Study Coordinator 314-747-8378
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897) \| Springfield, Missouri, 65804, United States	Recruiting	Study Coordinator 417-820-8099
St. Vincent Healthcare Frontier Cancer Center ( Site 1818) \| Billings, Montana, 59102, United States	Recruiting	Study Coordinator 406-238-6290
Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036) \| Basking Ridge, New Jersey, 07920, United States	Recruiting	Study Coordinator 631-623-4272
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039) \| Middletown, New Jersey, 07748, United States	Recruiting	Study Coordinator 631-623-4272
MSKCC-Bergen ( Site 2037) \| Montvale, New Jersey, 07645, United States	Recruiting	Study Coordinator 631-623-4272
The University of New Mexico Comprehensive Cancer Center ( Site 1882) \| Albuquerque, New Mexico, 87131, United States	Completed
Montefiore Einstein Center ( Site 2028) \| Bronx, New York, 10467, United States	Recruiting	Study Coordinator 718-405-8027
Erie County Medical Center ( Site 2047) \| Buffalo, New York, 14215, United States	Recruiting	Study Coordinator 716-898-3698
Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038) \| Commack, New York, 11725, United States	Recruiting	Study Coordinator 631-623-4272
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041) \| Harrison, New York, 10604, United States	Recruiting	Study Coordinator 631-623-4272
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014) \| New York, New York, 10016, United States	Recruiting	Study Coordinator 212-731-6465
Memorial Sloan Kettering Cancer Center ( Site 1857) \| New York, New York, 10065, United States	Recruiting	Study Coordinator 631-623-4272
Northwell Health Cancer Institute ( Site 2030) \| New York, New York, 10075, United States	Recruiting	Study Coordinator 212-434-3644
Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040) \| Uniondale, New York, 11553, United States	Recruiting	Study Coordinator 631-623-4272
Levine Cancer Institute ( Site 2003) \| Charlotte, North Carolina, 28204, United States	Recruiting	Study Coordinator 980-442-5217
Wake Forest Compenhensive Cancer Center ( Site 2029) \| Winston-Salem, North Carolina, 27357, United States	Completed
Sanford Health Roger Maris Cancer Center ( Site 2034) \| Fargo, North Dakota, 58122, United States	Recruiting	Study Coordinator 701-234-2441
University Hospitals ( Site 2032) \| Cleveland, Ohio, 44106, United States	Recruiting	Study Coordinator 216-844-6031
The Ohio State University ( Site 2012) \| Columbus, Ohio, 43210, United States	Recruiting	Study Coordinator 619-293-8074
Providence Portland Medical Center ( Site 1843) \| Portland, Oregon, 97220, United States	Recruiting	Study Coordinator 503-215-5696
Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022) \| Portland, Oregon, 97227, United States	Recruiting	Study Coordinator 503-331-6537
Oregon Health Sciences University ( Site 1871) \| Portland, Oregon, 97239, United States	Recruiting	Study Coordinator 503-494-8666
St. Luke's University Health Network ( Site 1801) \| Easton, Pennsylvania, 18045, United States	Recruiting	Study Coordinator 484-503-4156
Allegheny General Hospital ( Site 1833) \| Pittsburgh, Pennsylvania, 15212, United States	Recruiting	Study Coordinator 412-330-6129
Sanford Cancer Center Oncology Clinic ( Site 1859) \| Sioux Falls, South Dakota, 57104, United States	Recruiting	Study Coordinator 605-328-1365
Henry Joyce Cancer Clinic ( Site 1827) \| Nashville, Tennessee, 37232, United States	Recruiting	Study Coordinator 615-322-4967
UT Southwestern Medical Center ( Site 1841) \| Dallas, Texas, 75390, United States	Recruiting	Study Coordinator 214-648-6209
University of Utah, Huntsman Cancer Institute ( Site 1855) \| Salt Lake City, Utah, 84112-5550, United States	Recruiting	Study Coordinator 801-587-5562
University of Vermont Medical Center ( Site 2009) \| Burlington, Vermont, 05401, United States	Recruiting	Study Coordinator 802-656-9442
UVA Health System - Emily Couric Cancer Center ( Site 1826) \| Charlottesville, Virginia, 22908, United States	Recruiting	Study Coordinator 434-924-1904
Inova Schar Cancer Institute ( Site 2026) \| Fairfax, Virginia, 22031, United States	Recruiting	Study Coordinator 703-207-0733
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865) \| Seattle, Washington, 98109, United States	Recruiting	Study Coordinator 206-606-2048
Hospital Universitario Austral ( Site 0009) \| Pilar, Buenos Aires, B1629AHJ, Argentina	Completed
Hospital Britanico de Buenos Aires ( Site 0012) \| Ciudad de Buenos Aires, Caba, C1280AEB, Argentina	Recruiting	Study Coordinator +541143096897
Sanatorio Britanico ( Site 0013) \| Rosario, Santa Fe, S2000CVB, Argentina	Recruiting	Study Coordinator +54341156575134
Instituto de Oncologia de Rosario ( Site 0002) \| Rosario, Santa Fe, S2000KZE, Argentina	Recruiting	Study Coordinator +543414218909
Hospital Provincial del Centenario ( Site 0008) \| Rosario, Santa Fe, S2002KDS, Argentina	Recruiting	Study Coordinator +54341153702439
Hospital Aleman Buenos Aires Argentina ( Site 0004) \| Buenos Aires, C1118AAT, Argentina	Recruiting	Study Coordinator +54114827700x2306
Instituto de Oncología Angel Roffo ( Site 0003) \| Buenos Aires, C1417DTB, Argentina	Completed
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010) \| San Juan, J5402DIL, Argentina	Recruiting	Study Coordinator +5402644709367
The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051) \| Westmead, New South Wales, 2145, Australia	Recruiting	Study Coordinator +61298818421
Royal Brisbane and Women s Hospital ( Site 0050) \| Herston, Queensland, 4029, Australia	Recruiting	Study Coordinator +61736468111
Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901) \| Linz, Oberosterreich, 4010, Austria	Recruiting	Study Coordinator +4373276777356
Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902) \| Graz, Steiermark, 8036, Austria	Recruiting	Study Coordinator +433163858353
Medizinische Universitaet Wien ( Site 1903) \| Vienna, Wien, 1090, Austria	Recruiting	Study Coordinator +4314040044240
Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900) \| Salzburg, 5020, Austria	Recruiting	Study Coordinator +435725525801
Hopital de Jolimont ( Site 0103) \| Haine Saint Paul, Hainaut, 7100, Belgium	Recruiting	Study Coordinator +3227641992
UZ Gent ( Site 0101) \| Gent, Oost-Vlaanderen, 9000, Belgium	Recruiting	Study Coordinator +3293322811
AZ Nikolaas ( Site 0104) \| Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium	Recruiting	Study Coordinator +3237602683
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155) \| Salvador, Bahia, 40050-410, Brazil	Recruiting	Study Coordinator +557122038620
Centro Regional Integrado de Oncologia ( Site 0160) \| Fortaleza, Ceara, 60336-232, Brazil	Recruiting	Study Coordinator +558532865934
Liga Norte Riograndense Contra o Cancer ( Site 0171) \| Natal, Rio Grande Do Norte, 59075-740, Brazil	Recruiting	Study Coordinator +558440095595
Hospital Nossa Senhora da Conceicao ( Site 0165) \| Porto Alegre, Rio Grande Do Sul, 91359-200, Brazil	Recruiting	Study Coordinator +5551993590437
Hospital de Base de Sao Jose de Rio Preto ( Site 0153) \| Sao Jose do Rio Preto, Sao Paulo, 15090-000, Brazil	Recruiting	Study Coordinator +551732015154
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169) \| Rio de Janeiro, 20231-050, Brazil	Recruiting	Study Coordinator +552132336566
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167) \| Sao Paulo, 01246-000, Brazil	Recruiting	Study Coordinator +551138933555
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0175) \| Sao Paulo, 01321-001, Brazil	Recruiting	Study Coordinator +551135056698
Cross Cancer Institute ( Site 0201) \| Edmonton, Alberta, T6G 1Z2, Canada	Recruiting	Study Coordinator 7804328340
Princess Margaret Cancer Centre ( Site 0202) \| Toronto, Ontario, M5G 2M9, Canada	Recruiting	Study Coordinator 4169462911
McGill University Health Centre ( Site 0210) \| Montreal, Quebec, H4A 3J1, Canada	Recruiting	Study Coordinator 5149341934
Fundacion Arturo Lopez Perez FALP ( Site 0251) \| Santiago, Region M. De Santiago, 7500921, Chile	Recruiting	Study Coordinator +56224457254
Clinica de la Costa Ltda. ( Site 0307) \| Barranquilla, Atlantico, 080020, Colombia	Recruiting	Study Coordinator +57353369940
Centro de Investigacion Clinica del Country ( Site 0304) \| Bogota, Distrito Capital De Bogota, 110221, Colombia	Completed
Oncologos del Occidente S.A. ( Site 0310) \| Pereira, Risaralda, 661002, Colombia	Recruiting	Study Coordinator +573215430284
Centro Medico Imbanaco de Cali S.A ( Site 0300) \| Cali, Valle Del Cauca, 760042, Colombia	Completed
Centre Antoine Lacassagne ( Site 0351) \| Nice, Alpes-Maritimes, 06189, France	Recruiting	Study Coordinator +33492031747
Hopital de la Timone ( Site 0356) \| Marseille, Bouches-du-Rhone, 13005, France	Recruiting	Study Coordinator +33491385708
Institut Claudius Regaud IUCT Oncopole ( Site 0355) \| Toulouse, Haute-Garonne, 31059, France	Recruiting	Study Coordinator +33531155101
Institut Gustave Roussy ( Site 0353) \| Villejuif, Val-de-Marne, 94800, France	Recruiting	Study Coordinator +33142116532
Institut Sainte Catherine ( Site 0352) \| Avignon, Vaucluse, 84918, France	Recruiting	Study Coordinator +33490275760
Institut Curie ( Site 0350) \| Paris, 75248, France	Recruiting	Study Coordinator +33144324086
Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401) \| Tuebingen, Baden-Wurttemberg, 72076, Germany	Recruiting	Study Coordinator +4970712989158
Universitaetsklinikum Ulm ( Site 0402) \| Ulm, Baden-Wurttemberg, 89075, Germany	Recruiting	Study Coordinator +4973150059548
Klinikum rechts der Isar der Technischen Universitaet ( Site 0409) \| Muenchen, Bayern, 81675, Germany	Recruiting	Study Coordinator +498941406969
Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405) \| München, Bayern, 81675, Germany	Recruiting	Study Coordinator +4945150042000
Universitaetsklinikum Frankfurt ( Site 0403) \| Frankfurt, Hessen, 60590, Germany	Recruiting	Study Coordinator +496963017104
Klinikum Kassel GmbH ( Site 0404) \| Kassel, Hessen, 34125, Germany	Recruiting	Study Coordinator +495619803046
SRH Wald-Klinikum Gera GmbH ( Site 0406) \| Gera, Thuringen, 07548, Germany	Recruiting	Study Coordinator +493658282651
Universitaetsklinikum Hamburg Eppendorf ( Site 0407) \| Hamburg, 20246, Germany	Recruiting	Study Coordinator +4940741057122
Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452) \| Pecs, Baranya, 7334, Hungary	Recruiting	Study Coordinator +36302457110
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0450) \| Szolnok, Jasz-Nagykun-Szolnok, 5000, Hungary	Recruiting	Study Coordinator +36209323256
Magyar Honvedseg Egeszsegugyi Kozpont ( Site 0453) \| Budapest, 1062, Hungary	Recruiting	Study Coordinator +3614752538
Orszagos Onkologiai Intezet ( Site 0454) \| Budapest, 1122, Hungary	Recruiting	Study Coordinator +36122486003209
Sourasky Medical Center ( Site 0551) \| Tel Aviv, Tell Abib, 6423906, Israel	Recruiting	Study Coordinator +97527360734
Rambam Medical Center ( Site 0550) \| Afula, 1834111, Israel	Recruiting	Study Coordinator +972502061161
Hadassah Medical Center. Ein Kerem ( Site 0554) \| Jerusalem, 9112001, Israel	Recruiting	Study Coordinator +972508946244
Rabin Medical Center ( Site 0552) \| Petah Tikva, 4941492, Israel	Recruiting	Study Coordinator +97239378044
Chaim Sheba Medical Center. ( Site 0553) \| Ramat Gan, 5265601, Israel	Recruiting	Study Coordinator +97235302513
Aichi Cancer Center Hospital ( Site 0658) \| Nagoya, Aichi, 464-8681, Japan	Recruiting	Study Coordinator +81527626111
Hyogo Cancer Center ( Site 0656) \| Akashi, Hyogo, 673-8558, Japan	Recruiting	Study Coordinator +81789291151
Kagawa University Hospital ( Site 0651) \| Kita-gun, Kagawa, 761-0793, Japan	Recruiting	Study Coordinator +81878985111
Yokohama City University Hospital ( Site 0657) \| Yokohama, Kanagawa, 236-0004, Japan	Recruiting	Study Coordinator +81457872800
Chiba Cancer Center ( Site 0652) \| Chiba, 260-8717, Japan	Recruiting	Study Coordinator +81432645431
National Hospital Organization Kyushu Cancer Center ( Site 0660) \| Fukuoka, 811-1395, Japan	Recruiting	Study Coordinator +81925413231
Hiroshima University Hospital ( Site 0655) \| Hiroshima, 734-8551, Japan	Recruiting	Study Coordinator +81822575555
National Cancer Center Hospital ( Site 0650) \| Tokyo, 104-0045, Japan	Recruiting	Study Coordinator +81335422511
Medical Hospital, Tokyo Medical And Dental University ( Site 0654) \| Tokyo, 113-8519, Japan	Recruiting	Study Coordinator +81338136111
Tokyo Medical University Hospital ( Site 0659) \| Tokyo, 160-0023, Japan	Recruiting	Study Coordinator +81333426111
Chonnam National University Hwasun Hospital ( Site 0705) \| Hwasun Gun, Jeonranamdo, 58128, Korea, Republic of	Recruiting	Study Coordinator +82613797633
National Cancer Center ( Site 0702) \| Goyang-si, Kyonggi-do, 10408, Korea, Republic of	Completed
The Catholic University of Korea St. Vincent s Hospital ( Site 0704) \| Gyeonggi-do, Kyonggi-do, 16247, Korea, Republic of	Recruiting	Study Coordinator +82312498153
Seoul National University Bundang Hospital ( Site 0703) \| Seongnam-si, Kyonggi-do, 13620, Korea, Republic of	Recruiting	Study Coordinator +82317877037
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920) \| Lodz, Lodzkie, 93-513, Poland	Recruiting	Study Coordinator +48426895547
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905) \| Krakow, Malopolskie, 31-826, Poland	Recruiting	Study Coordinator +48606711181
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( \| Warszawa, Mazowieckie, 02-781, Poland	Recruiting	Study Coordinator +48225462208
Szpitale Pomorskie Sp. z o.o. ( Site 0935) \| Gdynia, Pomorskie, 81-159, Poland	Recruiting	Study Coordinator +48608875140
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901) \| Gliwice, Slaskie, 44-101, Poland	Recruiting	Study Coordinator +48604077641
Hospital de Braga ( Site 0951) \| Braga, 4710-243, Portugal	Recruiting	Study Coordinator +351253027000
CHLN Hospital Santa Maria ( Site 0952) \| Lisboa, 1649-035, Portugal	Recruiting	Study Coordinator +351217805000
Hospital CUF Descobertas ( Site 0953) \| Lisboa, 1998-018, Portugal	Recruiting	Study Coordinator +351210025200
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950) \| Porto, 4200-072, Portugal	Recruiting	Study Coordinator +351225084000
N.N. Blokhin NMRCO ( Site 1005) \| Moscow, Moskva, 115478, Russian Federation	Recruiting	Study Coordinator +74993249490
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000) \| Kazan, Tatarstan, Respublika, 420029, Russian Federation	Recruiting	Study Coordinator +79172662851
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001) \| Yaroslavl, Yaroslavskaya Oblast, 150054, Russian Federation	Recruiting	Study Coordinator +79036900449
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204) \| Badalona, Barcelona, 08916, Spain	Recruiting	Study Coordinator +34934978325
ICO L Hospitalet ( Site 1208) \| Hospitalet de Llobregat, Barcelona, 08908, Spain	Recruiting	Study Coordinator +34934014105
Hospital Clinico Universitario de Santiago ( Site 1207) \| Santiago de Compostela, La Coruna, 15706, Spain	Recruiting	Study Coordinator +34981950511
Hospital Vall D Hebron ( Site 1200) \| Barcelona, 08035, Spain	Recruiting	Study Coordinator +34932746000
Hospital Universitario La Paz ( Site 1201) \| Madrid, 28046, Spain	Recruiting	Study Coordinator +34917277516
Hospital Universitario Virgen del Rocio ( Site 1206) \| Sevilla, 41013, Spain	Recruiting	Study Coordinator +34955013068
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921) \| Bellinzona, Ticino, 6500, Switzerland	Recruiting	Study Coordinator +41918113497
Universitaetsspital Zurich ( Site 1923) \| Zuerich, Zurich, 8091, Switzerland	Recruiting	Study Coordinator +41442552214
Hopitaux Universitaires de Geneve HUG ( Site 1920) \| Geneve, 1211, Switzerland	Recruiting	Study Coordinator +41223729881
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303) \| Kaohsiung, 833, Taiwan	Recruiting	Study Coordinator +886975056508
Taichung Veterans General Hospital ( Site 1301) \| Taichung, 40705, Taiwan	Recruiting	Study Coordinator +886423592525
National Cheng Kung University Hospital ( Site 1302) \| Tainan, 704, Taiwan	Recruiting	Study Coordinator +886623535354559
National Taiwan University Hospital ( Site 1300) \| Taipei, 10002, Taiwan	Recruiting	Study Coordinator +886223123456
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709) \| Dnipropetrovsk, Dnipropetrovska Oblast, 49005, Ukraine	Recruiting	Study Coordinator +380950177304
Clinical oncology dispensary of Dnipro ( Site 1706) \| Dnipro, Dnipropetrovska Oblast, 49055, Ukraine	Completed
City Clinical Hosp.4 of DCC ( Site 1705) \| Dnipro, Dnipropetrovska Oblast, 49102, Ukraine	Recruiting	Study Coordinator +380675625054
Ukrainian Center of Tomotherapy ( Site 1708) \| Kropyvnitskiy, Kirovohradska Oblast, 25011, Ukraine	Recruiting	Study Coordinator +380979428527
PP PPC Acinus Medical and Diagnostic Centre ( Site 1704) \| Kropyvnytskyi, Kirovohradska Oblast, 25006, Ukraine	Recruiting	Study Coordinator +380503219357
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703) \| Kapitanivka Village, Kyivska Oblast, 08111, Ukraine	Recruiting	Study Coordinator +380974508529
National Cancer Institute of the MoH of Ukraine ( Site 1702) \| Kyiv, Kyivska Oblast, 03022, Ukraine	Recruiting	Study Coordinator +380955106107
LISOD. Hospital ( Site 1707) \| Pliuty, Kyiv, 08720, Ukraine	Recruiting	Study Coordinator +380506362519
Kyiv City Clinical Oncology Centre ( Site 1701) \| Kyiv, 03115, Ukraine	Completed
Castle Hill Hospital ( Site 1601) \| Cottingham-Hull, East Riding Of Yorkshire, HU165JQ, United Kingdom	Recruiting	Study Coordinator +441482461306
Guy s & St Thomas NHS Foundation Trust ( Site 1604) \| London, London, City Of, SE1 9RT, United Kingdom	Recruiting	Study Coordinator +442071882018
Royal Marsden Hospital - Fulham Road London ( Site 1609) \| London, London, City Of, SW3 6JJ, United Kingdom	Recruiting	Study Coordinator +442078118311
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603) \| London, London, City Of, W6 8RF, United Kingdom	Recruiting	Study Coordinator +442033118427
Weston Park Hospital ( Site 1607) \| Sheffield, S10 2SJ, United Kingdom	Recruiting	Study Coordinator +441142265237

Расположение Страны	Argentina Australia Austria Belgium Brazil Canada Chile Colombia France Germany Hungary Israel Japan Korea, Republic of Poland Portugal Russian Federation Spain Switzerland Taiwan Ukraine United Kingdom United States
Дата проверки	2021-04-01
Ответственная сторона	Тип: Спонсор
Ключевые слова	PD-1 PD1 gamle biler gamle biler gamle biler gamle biler PDL1 gamle biler
Имеет расширенный доступ	Нет
Количество рук	2
Группа вооружений	Метка: Pembro Neoadjuvant+Pembro SOC Adjuvant Тип: Experimental Описание: Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles as a neoadjuvant prior to surgery. Following surgical resection, high risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 every 3 weeks (Q3W) for fifteen 21-day cycles plus standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 Q3W for fifteen 21-day cycles plus standard of care radiotherapy as adjuvant therapy. Метка: gamle biler Тип: Активный компаратор Описание: gamle biler
Информация о дизайне исследования	Распределение: Рандомизированный Модель вмешательства: Параллельное присвоение Первичное назначение: Уход Маскировка: Нет (открытая этикетка)

Исследование применения пембролизумаба до операции и в сочетании с лучевой терапией после операции по запущенной плоскоклетке карциномы головы и шеи (MK-3475-689)