Исследование окиперлимаба с тислелизумабом по сравнению с пембролизумабом у пациентов с нелеченым раком легкого

Название протокола
Клинические исследование Non-small Cell Lung Cancer: Tislelizumab, Оциперлимаб, Пембролизумаб, Плацебо - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: BeiGene

Источник BeiGene
Краткое содержание

Цель исследования - сравнить выживаемость без прогрессирования (ВБП) между группой А. (оциперлимаб в сочетании с тислелизумабом) и Группа B (пембролизумаб в сочетании с плацебо) по оценке исследователей в соответствии с критериями оценки ответа в твердом Опухоли версии 1.1 (RECIST v1.1) и для сравнения общей выживаемости (ОС) между группой A и группой Б.

Общий статус Рекрутинг
Дата начала 2021-06-08
Дата завершения 2025-03-01
Дата первичного завершения 2024-11-01
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Progression-free Survival (PFS) As Assessed By Investigators Up to approximately 39 months
Общая выживаемость (ОС) по оценке исследователей Примерно до 39 месяцев
Вторичный результат
Мера Временное ограничение
PFS As Assessed By A Blinded Independent Review Committee Up to approximately 39 months
Общий коэффициент ответа (ЧОО) по оценке исследователей Примерно до 39 месяцев
Продолжительность ответа (DOR) по оценке исследователей Примерно до 39 месяцев
Качество жизни, связанное со здоровьем (HRQoL): Европейская организация по исследованию и лечению рака Опросник качества жизни Core 30 (EORTC QLQ-C30) В течение 7 дней после последней дозы
HRQoL: Опросник по качеству жизни модуля рака легких EORTC Рак легких 13 (QLQ-LC13) В течение 7 дней после последней дозы
HRQoL: вопросник 5-го уровня EuroQol 5 Dimension (EQ-5D-5L) В течение 7 дней после последней дозы
Время до ухудшения (TDD) В течение 7 дней после последней дозы
Количество участников, у которых возникли нежелательные явления (НЯ) 90 дней (± 14) после последней дозы
Регистрация 605
Состояние
  • Non-small Cell Lung Cancer
  • НМРЛ
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Tislelizumab

Описание: Tislelizumab is a monoclonal antibody formulated for intravenous injection.

Другое имя: BGB-A317

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Оциперлимаб

Описание: Оциперлимаб - это моноклональные антитела, предназначенные для внутривенных инъекций.

Этикетка Arm Group: Группа A: Тислелизумаб плюс Оциперлимаб

Другое имя: BGB-A1217

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Пембролизумаб

Описание: Пембролизумаб - это моноклональное антитело, разработанное для внутривенной инъекции.

Этикетка Arm Group: Группа B: пембролизумаб плюс плацебо

Другое имя: КЕЙТРУДА

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Плацебо

Описание: Инфузия плацебо будет состоять из стерильного физиологического раствора.

Приемлемость

Критерии:

Ключевые критерии включения: 1. Гистологически или цитологически задокументировано местно-распространенное или рецидивирующее немелкое клеточный рак легкого (НМРЛ), который не подходит для хирургического вмешательства и / или окончательного лучевая терапия с химиолучевой терапией или без нее, метастатически-неплоскостный или плоскоклеточный НМРЛ. 2. Отсутствие предшествующего системного лечения метастатического НМРЛ. 3. Согласие на предоставление архивной ткани (фиксированный формалином блок, залитый парафином. содержащие опухоль [предпочтительно] или от 6 до 15 свежесрезанных неокрашенных слайдов) или свежая биопсия (если архивная ткань недоступна) для проспективной централизованной оценки запрограммированных уровни лиганда-1 клеточной смерти (PD-L1) и ретроспективный анализ других биомаркеров. 4. Опухоли с экспрессией опухолевых клеток PD-L1 ≥ 50%, как определено централизованно. 5. По крайней мере, 1 измеримое поражение, как определено в RECIST v1.1. Ключевые критерии исключения: 1. Известная сенсибилизирующая мутация в гене рецептора эпидермального фактора роста (EGFR) или в гене онкоген слияния киназы анапластической лимфомы. 2. Предшествующая терапия антипрограммируемым белком клеточной смерти (анти-PD) -1, анти-PD-лигандом. (L) -1, анти-PD-лиганд-2, анти-Т-клеточный иммуноглобулин и домен ITIM (анти-TIGIT), или любое другое антитело или лекарство, специфически нацеленное на костимуляцию Т-клеток или контрольную точку пути. 3. Активное лептоменингеальное заболевание или неконтролируемые нелеченые метастазы в головной мозг. 4. Активные аутоиммунные заболевания или аутоиммунные заболевания в анамнезе, которые могут рецидивировать. 5. Любая активная злокачественная опухоль за период ≤ 2 лет до рандомизации, за исключением конкретного рака. исследуется в этом исследовании, а также любой местно-рецидивирующий рак, который лечить лечебно (например, резецированный базально или плоскоклеточный рак кожи, поверхностный рак мочевого пузыря, карцинома in situ шейки матки или груди). Примечание. Могут применяться другие критерии включения / исключения, определенные протоколом.

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

N / A

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Mark Socinski, MD Principal Investigator Advent Health Orlando
Общий контакт

Фамилия: BeiGene

Телефон: 1-877-828-5568

Расположение
Объект: Положение дел:
UAB O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama, 35294, United States Not yet recruiting
Alaska Oncology and Hematology, LLC | Anchorage, Alaska, 99508, United States Recruiting
Providence Medical Foundation | Fullerton, California, 92835, United States Recruiting
Advent Health Oncology and Hematology | Orlando, Florida, 32804, United States Recruiting
Goshen Center for Cancer Care | Goshen, Indiana, 46526, United States Recruiting
Baptist Health Lexington | Lexington, Kentucky, 40503, United States Recruiting
West Jefferson Medical Center Cancer Center (University Medical Center New Orleans) | Marrero, Louisiana, 70072, United States Not yet recruiting
Central Maine Medical Center | Lewiston, Maine, 04240, United States Recruiting
HealthPartners Institute - MMCORC (Metro Minnesota Community Oncology Research Consortium) | Saint Paul, Minnesota, 55426, United States Not yet recruiting
XCancer / Central Care Cancer Center | Bolivar, Missouri, 65613, United States Not yet recruiting
Saint Luke's Cancer Center | Kansas City, Missouri, 64111, United States Not yet recruiting
Penn State Health Cancer Institute | Hershey, Pennsylvania, 17033, United States Not yet recruiting
West Penn Hospital (Allegheny Health Network) | Pittsburgh, Pennsylvania, 15224, United States Not yet recruiting
Virginia Cancer Specialist, PC | Fairfax, Virginia, 22031, United States Recruiting
Concord Repatriation General Hospital | Concord, New South Wales, 2139, Australia Recruiting
Northern Cancer Institute, Genesis Care | Saint Leonards, New South Wales, 2065, Australia Recruiting
Calvary Mater Newcastle, Medical Oncology Trial Unit, Edith Street | Waratah, New South Wales, 2298, Australia Recruiting
The Prince Charles Hospital | Chermside, Queensland, 4032, Australia Not yet recruiting
Mater Cancer Care Centre | South Brisbane, Queensland, 4101, Australia Not yet recruiting
John Flynn Private Hospital | Tugun, Queensland, 4224, Australia Recruiting
Lyell McEwin Hospital | Elizabeth Vale, South Australia, 5112, Australia Recruiting
Ballarat Health Services | Ballarat, Victoria, 3350, Australia Recruiting
Monash Health | Clayton, Victoria, 3168, Australia Not yet recruiting
Western Health - Sunshine Hospital | St Albans, Victoria, 3021, Australia Recruiting
St John of God, Murdoch Hospital | Murdoch, Western Australia, 6150, Australia Recruiting
Anhui Provincial Hospital | Hefei, Anhui, 230000, China Not yet recruiting
Beijing Cancer Hospital | Beijing, Beijing, 100142, China Recruiting
Beijing Chest Hospital, Capital Medical University | Beijing, Beijing, 10149, China Recruiting
Southwest Hospital | Chongqing, Chongqing, 400038, China Not yet recruiting
Chongqing Three Gorges Central Hospital | Chongqing, Chongqing, 404000, China Not yet recruiting
Fujian Medical University Union Hospital | Fuzhou, Fujian, 350001, China Not yet recruiting
Fujian Cancer Hospital | Fuzhou, Fujian, 350014, China Not yet recruiting
The First Affiliated Hospital of Xiamen University | Xiamen, Fujian, 361003, China Not yet recruiting
Cancer Center of Guangzhou Medical University | Guangzhou, Guangdong, 510030, China Not yet recruiting
Cancer Hospital of Shantou University Medical College | Shantou, Guangdong, 515031, China Recruiting
Shenzhen People's Hospital | Shenzhen, Guangdong, 518020, China Not yet recruiting
Cancer Hospital of Guangxi Zhuang Autonomous Region | Nanning, Guangxi, 530021, China Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning, Guangxi, 530021, China Not yet recruiting
Affiliated Tumor Hospital of Harbin Medical University | Harbin, Heilongjiang, 150000, China Not yet recruiting
The First Affiliated Hospital of Zhengfzhou University | Zhengzhou, Henan, 400052, China Not yet recruiting
Henan Cancer Hospital | Zhengzhou, Henan, 450000, China Not yet recruiting
Henan Provincial People's Hospital | Zhengzhou, Henan, 450003, China Not yet recruiting
The First Affiliated Hospital of Zhengzhou University | Zhengzhou, Henan, 450052, China Not yet recruiting
Hubei Cancer Hospital | Wuhan, Hubei, 400037, China Recruiting
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei, 430023, China Recruiting
Renmin Hospital of Wuhan University | Wuhan, Hubei, 430060, China Recruiting
Changsha Central Hospital | Changsha, Hunan, 410004, China Not yet recruiting
The Second Xiangya Hospital of Central South University | Changsha, Hunan, 410011, China Not yet recruiting
Nanjing First Hospital | Nanjing, Jiangsu, 210009, China Not yet recruiting
Nanjing Chest Hospital | Nanjing, Jiangsu, 210029, China Recruiting
The First Affiliated Hospital of Soochow University | Suzhou, Jiangsu, 215006, China Not yet recruiting
Liaoning Cancer Hospital & Institute | Shenyang, Liaoning, 110042, China Not yet recruiting
The Affiliated Hospital of Qingdao University | Qingdao, Shandong, 266000, China Not yet recruiting
Weifang People's Hospital | Weifang, Shandong, 261000, China Recruiting
Shanghai Chest Hospital | Shanghai, Shanghai, 200030, China Recruiting
Shanxi Bethune Hospital | Taiyuan, Shanxi, 030032, China Recruiting
Sichuan Cancer Hospital & Institute | Chengdu, Sichuan, 610041, China Not yet recruiting
Tianjin Medical University General Hospital | Tianjin, Tianjin, 300052, China Recruiting
Tianjin Medical University Cancer Institute & Hospital | Tianjin, Tianjin, 300060, China Recruiting
Affiliated Cancer Hospital of Xinjiang Medical University | Ürümqi, Xinjiang, 830000, China Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou, Zhejiang, 310016, China Recruiting
Zhejiang Cancer Hospital | Hangzhou, Zhejiang, 310022, China Not yet recruiting
Ningbo First Hospital | Ningbo, Zhejiang, 315010, China Recruiting
Beijing Chao-Yang Hospital | Beijing, 100020, China Not yet recruiting
Peking Union Medical College Hospital | Beijing, 100730, China Not yet recruiting
Xiangya Hospital of Central South University | Changsha, 410008, China Not yet recruiting
Hunan Cancer Hospital | Changsha, 410013, China Not yet recruiting
Changzhou No.2 People's Hospital | Changzhou, 213003, China Recruiting
West China Hospital, Sichuan University | Chengdu, 610041, China Recruiting
Chongqing Cancer Hospital | Chongqing, 400030, China Recruiting
Daping Hospital, Third Military Medical University | Chongqing, 400042, China Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University | Guangzhou, 510120, China Not yet recruiting
The Second Hospital of Anhui Medical University | Hefei, 230601, China Not yet recruiting
The First Affiliated Hospital of Nanchang University | Nanchang, 330006, China Not yet recruiting
Affiliated Hospital of North Sichuan Medical College | Nanchong, 637000, China Recruiting
Affiliated Zhongshan Hospital of Fudan University | Shanghai, 200032, China Not yet recruiting
Shanghai Pulmonary Hospital | Shanghai, 200433, China Not yet recruiting
The Second Affiliated Hospital of Soochow University | Suzhou, 215000, China Not yet recruiting
Taizhou Hospital of Zhejiang Province | Taizhou, 317000, China Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an, 710061, China Not yet recruiting
Xuzhou Central Hospital | Xuzhou, 221000, China Not yet recruiting
Yantai Yuhuangding Hospital | Yantai, 264000, China Not yet recruiting
The Fourth Affiliated Hospital Zhejinaang University School of Medicine | Yiwu, 322000, China Not yet recruiting
Institut de Cancérologie de L'Ouest | Angers, 49055, France Not yet recruiting
Centre Hospitalier de la Cote Basque - Saint Léon - Service de Pneumologie | Bayonne, 64109, France Not yet recruiting
Hospices Civils de Lyon- Hopital Louis Pradel | Bron, 69500, France Recruiting
Chi de Creteuil | Créteil, 94000, France Not yet recruiting
Hospices Civils de Lyon-Hôpital de la Croix Rousse | Lyon, 69004, France Recruiting
Centre Leon Berard | Lyon, 69373, France Not yet recruiting
ICM Val Daurelle - Oncologie Médicale | Montpellier, 34298, France Recruiting
Centre Hospitalier Emile Muller Ghrmsa | Mulhouse, 68100, France Not yet recruiting
Clinique Gentilly | Nancy, 54100, France Not yet recruiting
Centre Hospitalier Universitaire Nantes-Hotel Dieu | Nantes, 44093, France Not yet recruiting
Hopital Cochin | Paris, 75014, France Not yet recruiting
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud | Pierre-Bénite, 69310, France Recruiting
HIA Begin | Saint-Mandé, 94160, France Recruiting
Chu Tours - Hopital Bretonneau - Service Pneumologie 2 | Tours, 37000, France Not yet recruiting
High Technology Hospital Medcenter LTD | Batumi, 6000, Georgia Not yet recruiting
Acad. Fridon Todua medical Center LTD - Research Institute of Clinical Medicine LTD | Tbilisi, 0112, Georgia Not yet recruiting
Israel-Georgian Medical Research Clinic Helsicore LTD | Tbilisi, 0112, Georgia Not yet recruiting
New Hospitals LTD | Tbilisi, 0114, Georgia Not yet recruiting
Multiprofile Clinic Consilium Medula LTD | Tbilisi, 0186, Georgia Not yet recruiting
Oncology Research Center LTD | Tbilisi, 0186, Georgia Not yet recruiting
Timi - Tbilisi Institute of Medicine LTD | Tbilisi, 0186, Georgia Not yet recruiting
Universitaetsklinikum Aachen | Aachen, 52074, Germany Not yet recruiting
Helios Klinikum Bad Saarow | Bad Saarow, 15526, Germany Not yet recruiting
Charite Universitatsmedizin Berlin | Berlin, 13353, Germany Not yet recruiting
Asklepios Fachklinik Munchen-Gauting | Gauting, 82131, Germany Not yet recruiting
Lungenclinic Grosshansdorf GMBH | Großhansdorf, 22927, Germany Not yet recruiting
Ambulantes Krebszentrum Hamburg | Hamburg, 20251, Germany Not yet recruiting
Uniklinikum Giessen Marburg | Heidelberg, 35392, Germany Not yet recruiting
Universitatsklinikum Bonn | Kiel, 53127, Germany Not yet recruiting
Kliniken Der Stadt Koeln GGMBH | Köln, 51109, Germany Not yet recruiting
Onkologische Scwerpunktpraxis Leer - Emden | Leer, 26789, Germany Not yet recruiting
Klinikum Ludwigshafen, Medizinische Klinik A | Ludwigshafen, 67063, Germany Not yet recruiting
Klinikum Johannes-Gutenberg-Universitaet Mainz | Mainz, 55131, Germany Not yet recruiting
Klinikum Der Universitat muenchen - Campus Innenstadt | Muenchen, 80336, Germany Not yet recruiting
Muenchen Klinik Bogenhausen | Muenchen, 80336, Germany Not yet recruiting
Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige GMBH | Rotenburg, 27356, Germany Not yet recruiting
Universitaetsklinikum Ulm, Innere Medizin III | Ulm, 89081, Germany Not yet recruiting
Onkologische Schwerpunkt-Praxis-Worms | Worms, 57547, Germany Not yet recruiting
The Catholic University of Korea, Bucheon St. Mary's Hospital | Gyeonggi-do, Bucheon-si, 14647, Korea, Republic of Recruiting
Kyungpook National University Chilgok Hospital | Daegu, Buk-gu, 41404, Korea, Republic of Recruiting
Chungbuk National University Hospital | Cheongju-si, Chungcheongbuk-do, 28644, Korea, Republic of Recruiting
Keimyung University Dongsan Hospital | Daegu, Dalseo-gu, 42601, Korea, Republic of Not yet recruiting
The Catholic University of Korea Eunpyeong St. Mary's Hospital | Seoul, Eunpyeong-gu, 03312, Korea, Republic of Not yet recruiting
Inje University Haeundae Paik Hospital | Busan, Haeundae-gu, 48108, Korea, Republic of Recruiting
Meander Medisch Centrum | Amersfoort, 3813, Netherlands Not yet recruiting
Stichting Het Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis | Amsterdam, 1066, Netherlands Not yet recruiting
Rijnstate | Arnhem, 6815, Netherlands Not yet recruiting
Ziekenhuis St Jansdal | Harderwijk, 3844, Netherlands Not yet recruiting
Stichting Zuyderland Medisch Centrum | Heerlen, 6419, Netherlands Not yet recruiting
Isala Klinieken Zwolle | Zwolle, 8025, Netherlands Not yet recruiting
Arkhangelsk Regional Clinical Oncological Dispensary | Arkhangel'sk, 163045, Russian Federation Not yet recruiting
State Budgetary Healthcare Institution-Chelyabinsk Regional Clinical Center of Oncology and Nuclear | Chelyabinsk, 454087, Russian Federation Not yet recruiting
Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical" | Kursk, 305035, Russian Federation Not yet recruiting
State Budgetary Healthcare Institution-Regional Oncology Dispensary Number 2 | Magnitogorsk, 455001, Russian Federation Not yet recruiting
"Vitamed" LLC | Moscow, 121309, Russian Federation Not yet recruiting
State Budgetary Healthcare Institution "City Clinical Hospital #1" | Nalchik, 360000, Russian Federation Not yet recruiting
State Budgetary Healthcare Institution - Nizhny Novgorod Regional Clinical Oncology Dispensary | Nizhny Novgorod, 603081, Russian Federation Not yet recruiting
BIH of OMSK Region "Clinical Oncology Dispensary" | Omsk, 644013, Russian Federation Not yet recruiting
Private Healthcare Institution - Clinical Hospital Russian Railways - Medicine of the City of St. Petersburg | Saint Petersburg, 195271, Russian Federation Not yet recruiting
Private Medical Institution "Evromedservis" | Saint Petersburg, 196603, Russian Federation Not yet recruiting
LLC AV-Medical Group | Saint Petersburg, 197082, Russian Federation Not yet recruiting
The Smorodintsev Research Institute of Influenze | Saint Petersburg, 197376, Russian Federation Not yet recruiting
FSBI "Clinical Research and Practical Center for Specialized Medical Care (Oncology)" | Saint Petersburg, 197758, Russian Federation Not yet recruiting
FSBI "National Medical Research Center for Oncology N.A.N.N. Petrov" of the MOH of the RF | Saint Petersburg, 197758, Russian Federation Not yet recruiting
State Budgetary Healthcare Institution - Samara Regional Clinical Oncology Dispensary | Samara, 443031, Russian Federation Not yet recruiting
Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Morodov" | Saransk, 430032, Russian Federation Not yet recruiting
State Autonomous Healthcare Institution - Republican Clinical Oncological Dispensary of the Republic | Ufa, 450054, Russian Federation Not yet recruiting
ICO-H.U.G. Trias I Pujol | Badalona, 08916, Spain Not yet recruiting
Hospital Del Mar | Barcelona, 08003, Spain Not yet recruiting
Hospital Universitari Quiron Dexeus | Barcelona, 08028, Spain Recruiting
Hospital Universitario Vall D'Hebron | Barcelona, 8035, Spain Recruiting
Hospital Universitario Donostia | Donostia, 20014, Spain Not yet recruiting
Hospital General Universitario de Elche | Elche, 03203, Spain Recruiting
ICO Girona | Girona, 17007, Spain Not yet recruiting
Hospital Universitario Insularde Gran Canaria | Las Palmas, 35016, Spain Not yet recruiting
Hospital Universitario Lucus Augusti | Lugo, 27003, Spain Not yet recruiting
Hospital Clinico San Carlos | Madrid, 28040, Spain Not yet recruiting
Start Madrid-Fundacion Jimenez Diaz | Madrid, 28040, Spain Not yet recruiting
Hospital Universitario Doce de Octubre | Madrid, 28041, Spain Recruiting
Hospital Universitario La Paz | Madrid, 28046, Spain Not yet recruiting
Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda, 28220, Spain Recruiting
Hospital General Universitario Morales Meseguer | Murcia, 30008, Spain Not yet recruiting
Hospital Universitario Virgen de la Victoria | Málaga, 29010, Spain Recruiting
Hospital Regional Universitario de Malaga | Málaga, 29011, Spain Not yet recruiting
Complexo Hospitalario Universitario de Ourense | Orense, 32005, Spain Not yet recruiting
Hospital Universitari son Espases | Palma De Mallorca, 07120, Spain Not yet recruiting
Hospital Universitario Nuestra Señora de Valme | Sevilla, 41014, Spain Not yet recruiting
Consorcio Hospital General Universitario de Valencia | Valencia, 46014, Spain Not yet recruiting
Hospital Arnau de Vilanova | Valencia, 46015, Spain Not yet recruiting
Hospital Universitari I Politecnic La Fe | Valencia, 46026, Spain Not yet recruiting
Changhua Christian Hospital | Changhua, 50006, Taiwan Recruiting
Kaohsiung Chang Gung Memorial Hospital | Kaohsiung, 83301, Taiwan Recruiting
Chung Shan Medical University Hospital | Taichung, 40201, Taiwan Not yet recruiting
China Medical University Hospital | Taichung, 40447, Taiwan Not yet recruiting
Taichung Veterans General Hospital | Taichung, 40705, Taiwan Recruiting
Taipei Veterans General Hospital | Taipei, 11217, Taiwan Recruiting
Taipei Tzu Chi Hospital | Taipei, 231405, Taiwan Recruiting
Linkou Chang Gung Memorial Hospital | Taoyuan, 33305, Taiwan Recruiting
National Taiwan University Hospital Yunlin Branch | Yuanlin, 00640, Taiwan Recruiting
Acibadem Adana Hospital | Adana, 01130, Turkey Not yet recruiting
Baskent University Practice and Research Hospital Adana - Medical Oncology Department | Adana, 01240, Turkey Not yet recruiting
İInönü Üniversitesi Tip Fakültesi | Battalgazi, 44280, Turkey Not yet recruiting
Trakya University Medical Faculty | Edirne, 22030, Turkey Not yet recruiting
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty | Istanbul, 34096, Turkey Not yet recruiting
Istanbul Medeniyet Uni Goztepe Training & Res Hosp | Istanbul, 34854, Turkey Not yet recruiting
Ege University Medical Faculty | İzmir, 35100, Turkey Not yet recruiting
Necmettin Erbakan University Selcuklu Faculty of Medicine | Meram, 42090, Turkey Not yet recruiting
Bukovynian Clinical Oncology Center | Chernivtsi, 58013, Ukraine Not yet recruiting
Komunalne Nekomertsiine Pidryiemstvo - Miska Klinichna Likarnia #4 | Dnepropetrovsk, 49102, Ukraine Not yet recruiting
Komunalne Nekomertsiine Pidryiemstvo Oblasnyi Tsentr Onkolohii | Kharkiv, 61070, Ukraine Not yet recruiting
Communal Non-profit Institution of Kharkiv Regional Council "Regional Clinical Specialized Health Di | Kharkiv, 61166, Ukraine Not yet recruiting
Kryvyi RIH Oncological Dispensary | Kryvyi Rih, 50048, Ukraine Not yet recruiting
Medical Center "Verum" Limited Liability Company | Kyiv, 03039, Ukraine Not yet recruiting
Public Non-profit Institution "Kyiv City Clinical Oncology Center" | Kyiv, 03115, Ukraine Not yet recruiting
Volyn Regional Medical Center of Oncology | Luts'k, 43018, Ukraine Not yet recruiting
Lviv State Regional Oncology Treatment and Diagnostic Center | Lviv, 79031, Ukraine Not yet recruiting
Odessa Regional Oncological Dispensary | Odesa, 65010, Ukraine Not yet recruiting
Communal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar | Sumy, 40003, Ukraine Not yet recruiting
Lira Oncological Clinic | Uzhgorod, 88000, Ukraine Not yet recruiting
Zakarpatska Regional Clinical Oncological Center | Uzhgorod, 88011, Ukraine Not yet recruiting
Podolsk Regional Oncology Center | Vinnytsia, 21029, Ukraine Not yet recruiting
Zaporozhye Regional Antitumor Center | Zaporizhia, 69061, Ukraine Not yet recruiting
Zaporozhye Regional Antitumor Center | Zaporizhzhia, 69054, Ukraine Not yet recruiting
Расположение Страны

Australia

China

France

Georgia

Germany

Korea, Republic of

Netherlands

Russian Federation

Spain

Taiwan

Turkey

Ukraine

United States

Дата проверки

2021-11-01

Ответственная сторона

Тип: Спонсор

Ключевые слова
  • Locally Advanced
  • Неоперабельный
  • Метастатический
  • Тислелизумаб
  • BGB-A317
  • Оциперлимаб
  • BGB-A1217
  • Пембролизумаб
  • Анти-TIGIT
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Количество рук 3
Группа вооружений

Метка: Arm A: Tislelizumab plus Ociperlimab

Тип: Experimental

Описание: Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.

Метка: Группа B: пембролизумаб плюс плацебо

Тип: Активный компаратор

Описание: Участники будут получать пембролизумаб 200 мг внутривенно, а затем плацебо внутривенно один раз в 3 недели.

Метка: Группа C: тислелизумаб плюс плацебо

Тип: Компаратор плацебо

Описание: Участники будут получать тислелизумаб 200 мг внутривенно, а затем плацебо внутривенно один раз в 3 недели.

Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Трехместный (участник, поставщик медицинских услуг, исследователь)