Исследование TAR-200 в сочетании с цетрелимабом по сравнению с лучевой терапией у участников с мышечно-инвазивным раком мочевого пузыря (MIBC) мочевого пузыря

Название протокола
Клинические исследование Новообразование мочевого пузыря: Cetrelimab, ТАР-200, Цисплатин, гемцитабин, Обычная лучевая терапия, Гипофракционированная лучевая терапия - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Janssen Research & Development, LLC

Источник Janssen Research & Development, LLC
Краткое содержание

Цель исследования - сравнение выживаемости без событий интактного мочевого пузыря (BI-EFS) в участники, получавшие TAR-200, оставшиеся с цетрелимабом, по сравнению с одновременным химиолучевая терапия.

Подробное описание

TAR-200 — экспериментальная система доставки лекарств. Цетрелимаб (JNJ-63723283) представляет собой полностью обнаружен иммуноглобулин G4 (IgG4) каппа-моноклональное антитело (mAb), который связывается с запрограммированной клеткой белок смерти 1 (PD-1). Исследование состоит из фаз скрининга продолжительности 42 дня, фаз лечения и последующая фаза. Общая продолжительность обучения составляет до 8 лет. оценка эффективности включают случаи заболеваний (цистоскопия/ТУР, биопсия/патология) и результаты, о которых сообщают пациенты (Оценка качества жизни) и оценка безопасности включают в себя измерение основных активов, электрокардиограмма (ЭКГ) в 12 исследованиях, физикальное обследование, клинические лабораторные анализы, цистоскопическое исследование, определение антител к лекарственным препаратам (АДА), сопутствующие лечение/процедуры и необычного наблюдения за объектами.

Общий статус Рекрутинг
Дата начала 2020-12-07
Дата завершения 2028-12-31
Дата первичного завершения 2026-12-30
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Время от рандомизации первого до заражения бессобытийным выживанием с неповрежденным мочевым пузырем (BI-EFS) до 8 лет
Вторичный результат
Мера Временное ограничение
Metastasis-free survival (MFS) Up to 8 years
Общая выживаемость (ОС) до 8 лет
Farmakokinetisk studie av pyrotinib och docetaxel i kombination med trastuzumab hos patienter med HER2 metastaserad bröstcancer до 8 лет
Количество участников с нежелательными явлениями (НЯ) в соответствии с общими терминологическими критериями нежелательных явлений (CTCAE) до 8 лет
Количество участников с НЯ по степени тяжести в соответствии с отчетом пациентов. Версия общих терминологических критериев нежелательных явлений (NCI PRO-CTCAE) до 8 лет
Количество участников с клиническими лабораторными отклонениями до 8 лет
Регистрация 550
Состояние
  • Новообразование мочевого пузыря
Вмешательство

Тип вмешательства: Biological

Название вмешательства: Cetrelimab

Описание: Participants will receive intravenous Cetrelimab.

Этикетка Arm Group: TAR-200 + Cetrelimab

Другое имя: JNJ-63723283

Тип вмешательства: средство, препарат

Название вмешательства: ТАР-200

Описание: Участники получают внутрипузырный TAR-200.

Этикетка Arm Group: ТАР-200 + Цетрелимаб

Другое имя: JNJ-17000139

Тип вмешательства: средство, препарат

Название вмешательства: Цисплатин

Описание: Участники получают цисплатин внутривенно.

Этикетка Arm Group: Химиотерапия (цисплатин или гемцитабин) + лучевая терапия

Тип вмешательства: средство, препарат

Название вмешательства: гемцитабин

Описание: Участники будут получать гемцитабин внутривенно.

Этикетка Arm Group: Химиотерапия (цисплатин или гемцитабин) + лучевая терапия

Тип вмешательства: Радиация

Название вмешательства: Обычная лучевая терапия

Описание: Участники принимают обычную лучевую терапию мочевого пузыря (64 Гр).

Этикетка Arm Group: Химиотерапия (цисплатин или гемцитабин) + лучевая терапия

Тип вмешательства: Радиация

Название вмешательства: Гипофракционированная лучевая терапия

Описание: Участники принимают гипофракционную лучевую терапию мочевого пузыря (55 Гр).

Этикетка Arm Group: Химиотерапия (цисплатин или гемцитабин) + лучевая терапия

Приемлемость

Критерии:

Критерии включения: - Не имеет права или решил не подвергаться внутренней цистэктомии - Все особые явления, связанные с любой предшествующей операцией и/или внутрипузырной терапией, должны принято решение об общих терминологических критериях природных объектов (CTCAE) версии 5.0. Марка меньше (=) 1500/куб.мм (мм^3); Количество тромбоцитов >=80 000/мм^3; Гемоглобин >=9,0 грамм на децилитр (г/дл); Функция печени: (Общий билирубин меньше или равен (

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

Н/Д

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Janssen Research & Development, LLC Clinical Trials Study Director Janssen Research & Development, LLC
Общий контакт

Фамилия: Study Contact

Телефон: 844-434-4210

Расположение
Объект: Положение дел:
Bladder Cancer Genitourinary Oncology | Phoenix, Arizona, 85032, United States Withdrawn
University of Southern California | Los Angeles, California, 90033, United States Recruiting
University of California Irvine Medical Center | Orange, California, 92868, United States Not yet recruiting
The Urology Center of Colorado | Denver, Colorado, 80211, United States Recruiting
Foothills Urology - Golden Off | Golden, Colorado, 80401, United States Recruiting
UF Health Jacksonville | Jacksonville, Florida, 32209, United States Withdrawn
Winship Cancer Institute of Emory University | Atlanta, Georgia, 30322, United States Not yet recruiting
The University Of Chicago Medicine | Chicago, Illinois, 60637, United States Withdrawn
DuPage Medical Group | Lisle, Illinois, 60532, United States Recruiting
Johns Hopkins Medical Institutions | Baltimore, Maryland, 21287, United States Withdrawn
University Hospitals Seidman Cancer Center | Ann Arbor, Michigan, 48109, United States Not yet recruiting
Adult Pediatric Urology & Urogynecology, P.C | Omaha, Nebraska, 68114, United States Withdrawn
New Jersey Urology LLC | Voorhees, New Jersey, 08043, United States Recruiting
Roswell Park Comprehensive Cancer Center | Buffalo, New York, 14263, United States Withdrawn
Winthrop University Hospital | Mineola, New York, 11501, United States Withdrawn
NYU Langone Health | New York, New York, 10017, United States Withdrawn
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States Withdrawn
Columbia University Medical Center, Herbert Irving Pavilion | New York, New York, 10032, United States Withdrawn
Associated Medical Professionals | Syracuse, New York, 13210, United States Not yet recruiting
Duke University Medical Center | Durham, North Carolina, 27710, United States Recruiting
Vidant Urology - Greenville | Greenville, North Carolina, 27834, United States Not yet recruiting
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center | Winston-Salem, North Carolina, 27103, United States Not yet recruiting
Ohio State University | Columbus, Ohio, 43210, United States Withdrawn
Oklahoma City VAMC | Oklahoma City, Oklahoma, 73104, United States Withdrawn
Stephenson Cancer Center | Oklahoma City, Oklahoma, 73104, United States Not yet recruiting
Oregon Urology Institute | Springfield, Oregon, 97477, United States Withdrawn
MidLantic Urology | Bala-Cynwyd, Pennsylvania, 19004, United States Recruiting
Thomas Jefferson University | Philadelphia, Pennsylvania, 19107, United States Withdrawn
Allegheny | Pittsburgh, Pennsylvania, 15212, United States Withdrawn
Carolina Urologic Research Center | Myrtle Beach, South Carolina, 29572, United States Recruiting
Urology Associates, PC | Nashville, Tennessee, 37209, United States Not yet recruiting
Rio Grande Urology | El Paso, Texas, 79912, United States Withdrawn
University of Texas Medical Branch | League City, Texas, 77573, United States Recruiting
Virginia Oncology Associates | Norfolk, Virginia, 23502, United States Recruiting
Spokane Urology | Spokane, Washington, 99202, United States Withdrawn
Fundacion Intecnus | Bariloche, 8400, Argentina Not yet recruiting
Hospital Sirio Libanes | Buenos Aires, C1419AHN, Argentina Recruiting
Instituto Medico Especializado Alexander Fleming | Buenos Aires, C1426ANZ, Argentina Not yet recruiting
Hospital Italiano de Buenos Aires | Ciudad Autónoma De Buenos Aires, C1199ABB, Argentina Not yet recruiting
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Córdoba, 5000, Argentina Recruiting
Centro Urologico Profesor Bengio | Córdoba, X5000KPH, Argentina Not yet recruiting
Sanatorio Allende Cerro | Córdoba, X5004FHP, Argentina Not yet recruiting
Centro Oncologico Riojano Integral (Cori) | La Rioja, F5300COE, Argentina Not yet recruiting
Centro de Investigacion Pergamino SA | Pergamino, B2700CPM, Argentina Not yet recruiting
Instituto de Oncologia de Rosario | Rosario, S2000KZE, Argentina Not yet recruiting
CEDIC Centro de Investigaciones Clinicas | Viedma, R8500EYO, Argentina Not yet recruiting
Flinders Medical Centre | Bedford Park, 5042, Australia Recruiting
Royal North Shore Hospital | St Leonards, 2065, Australia Not yet recruiting
Krankenhaus der barmherzigen Schwestern | Linz, 4010, Austria Recruiting
KH.D Barmherzige Bruder Salzburg | Salzburg, 5010, Austria Withdrawn
Universitätsklinikum Salzburg - Landeskrankenhaus | Salzburg, 5020, Austria Recruiting
Krankenhaus der Barmherzigen Brüder | Vienna, 1020, Austria Withdrawn
Medizinische Universität Wien | Wien, 1090, Austria Not yet recruiting
Wilhelminenspital der Stadt Wien | Wien, 1160, Austria Not yet recruiting
Hopital Erasme | Anderlecht, 1070, Belgium Recruiting
ZNA Middelheim | Antwerpen, 2020, Belgium Not yet recruiting
AZ Sint-Lucas | Assebroek, 8310, Belgium Recruiting
Algemeen Ziekenhuis Klina | Brasschaat, 2930, Belgium Withdrawn
AZ Sint-Jan Brugge-Oostende AV | Brugge, 8000, Belgium Recruiting
Az Groeninge | Kortrijk, 8500, Belgium Recruiting
Fundacao Pio Xii - Hospital De Cancer De Barretos | Barretos, 14784, Brazil Recruiting
Fundação Hospitalar São Francisco de Assis | Belo Horizonte, 31110-580, Brazil Recruiting
Hospital Erasto Gaertner | Curitiba, 81520-060, Brazil Not yet recruiting
Centro de Pesquisas Oncológicas - CEPON | Florianópolis, 88034-000, Brazil Withdrawn
Centro Regional Integrado de Oncologia - Crio | Fortaleza, 60336-045, Brazil Not yet recruiting
Hospital de Caridade de Ijui | Ijuí, 98700-000, Brazil Not yet recruiting
Clinica de Oncologia Reichow | Jardim Blumenau, 89010-340, Brazil Recruiting
Hospital Amaral Carvalho | Jaú, 17210-180, Brazil Recruiting
Liga Norte Riograndense Contra O Cancer | Natal, 59062-000, Brazil Recruiting
Hospital das Clinicas de Porto Alegre | Porto Alegre, 90035-903, Brazil Not yet recruiting
Hospital São Lucas - PUCRS | Porto Alegre, 90610-000, Brazil Not yet recruiting
Hospital Sao Rafael | Salvador, 41253-190, Brazil Recruiting
CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia | Santo André, 09060-650, Brazil Recruiting
ICESP - Instituto do Câncer do Estado de São Paulo | Sao Paolo, 01246, Brazil Not yet recruiting
Hospital Sirio Libanes | Sao Paulo, 04784180, Brazil Not yet recruiting
Fundação Faculdade de Medicina de São José Do Rio Preto | São José Do Rio Preto, 15090000, Brazil Recruiting
Instituto de Assistência Médica ao Servidor Público Estadual - HSPE-FMO | São Paulo, 04039-004, Brazil Not yet recruiting
Centro Oncológico do Triângulo | Uberlândia, 38408-150, Brazil Not yet recruiting
Exdeo Clinical Research Inc | Abbotsford, British Columbia, V2T1X8, Canada Not yet recruiting
Vancouver General Hospital | Vancouver, British Columbia, V6H 3Z6, Canada Withdrawn
The Male/Female Health and Research Centre | Barrie, Ontario, L4M 7G1, Canada Not yet recruiting
William Osler Health System | Brampton, Ontario, L6R 3J7, Canada Not yet recruiting
University of Toronto | Toronto, Ontario, M5G 2M9, Canada Not yet recruiting
McGill University Health Centre | Montreal, Quebec, H4A 3J1, Canada Not yet recruiting
CHU de Québec -L'Hôtel-Dieu de Québec | Québec, Quebec, G1R 2J6, Canada Not yet recruiting
Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke, Quebec, J1H 5H3, Canada Not yet recruiting
Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC) | Beijing, 100021, China Not yet recruiting
Peking University First Hospital | Beijing, 100034, China Not yet recruiting
Peking University Third Hospital | Beijing, 100191, China Not yet recruiting
Beijing Hospital | Beijing, 100730, China Not yet recruiting
The First Hospital of Jilin University | Changchun, 130021, China Not yet recruiting
Hunan Cancer hospital | Changsha Shi, 410013, China Not yet recruiting
The Third Xiangya Hospital of Central Sourth University | Changsha, 410013, China Not yet recruiting
General Hospital of Western Theater Command PLA | Chengdu Shi, 610083, China Not yet recruiting
West China Hospital of Sichuan University | Chengdu, 610041, China Not yet recruiting
Chongqing University Cancer Hospital | Chongqing, 400030, China Not yet recruiting
First Affiliated Hospital of Dalian Medical University | Dalian, 116011, China Not yet recruiting
Sun Yat-Sen University Cancer Center | Guangzhou, 510060, China Not yet recruiting
Guangzhou Medical University | Guangzhou, 510095, China Not yet recruiting
Zhejiang Provincial People's Hospital | Hangzhou, 310014, China Not yet recruiting
The First Affiliated Hospital of NanChang University | Nanchang, 330006, China Withdrawn
Nanjing Drum Tower Hospital | Nanjing, 210008, China Not yet recruiting
Qingdao Municipal Hospital | Qingdao, 266011, China Not yet recruiting
Renji Hospital | Shanghai, 200020, China Not yet recruiting
Shengjing Hospital of China Medical University | Shenyang, 110004, China Not yet recruiting
Liaoning Cancer Hospital & Institute | Shenyang, 110042, China Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University | Wenzhou Shi, 325000, China Not yet recruiting
Wuhan Union Hospital | Wuhan, 430022, China Not yet recruiting
Wuhan Tongji Hospital, Tongji Medical College | Wuhan, 430030, China Not yet recruiting
Yantai Yuhuangding Hospital | Yantai, 264000, China Not yet recruiting
Henan Cancer Hospital | Zhengzhou, 450008, China Not yet recruiting
Kromerizska nemocnice a.s. | Kromeriz, 767 01, Czechia Withdrawn
Slezska nemocnice v Opave | Opava, 746 01, Czechia Recruiting
Fakultni nemocnice Plze | Plzen-Bory, 305 99, Czechia Recruiting
Urocentrum Praha | Praha 2, 120 00, Czechia Not yet recruiting
Vseobecna fakultni nemocnice v Praze | Praha 2, 128 08, Czechia Not yet recruiting
Thomayerova nemocnice | Praha 4, 140 59, Czechia Recruiting
Fakultni nemocnice v Motole | Praha 5, 150 06, Czechia Not yet recruiting
Androgeos S.R.O. | Praha 6, 160 00, Czechia Not yet recruiting
Nemocnice Na Bulovce | Praha 8, 180 81, Czechia Not yet recruiting
Fakultni nemocnice Kralovske Vinohrady | Praha, 100 34, Czechia Not yet recruiting
Krajska Nemocnice Tomase Bati | Zlin, 76275, Czechia Withdrawn
Hôpital Côte de Nacre | Caen cedex 9, 14033, France Withdrawn
Clinique Sainte Marguerite | Hyeres, 83400, France Recruiting
Polyclinique de Limoges - Francois Chenieux | Limoges, 87000, France Recruiting
Hôpital Edouard Herriot | Lyon Cedex 03, 69437, France Recruiting
Institut Paoli-Calmettes | Marseille, 13009, France Recruiting
Institut Regional du Cancer de Montpellier | Montpellier, 34298, France Recruiting
CHU Nîmes | Nimes, 30029, France Recruiting
Hopital Europeen Georges-Pompidou | Paris, 75015, France Recruiting
Hôpital Bichat - Claude Bernard | Paris, 75018, France Recruiting
CHU De Poitiers | Poitiers, 86021, France Withdrawn
Centre Hospitalier Prive | Saint-Grégoire, 35760, France Recruiting
Institut Universitaire du Cancer Toulouse Oncopole | Toulouse Cedex 9, 31059, France Withdrawn
Marien-Krankenhaus GmbH Bergisch Gladbach | Bergisch Gladbach, 51465, Germany Withdrawn
Urologicum Duisburg | Duisburg, 47179, Germany Recruiting
Universitätsklinikum Düsseldorf | Düesseldorf, 40225, Germany Not yet recruiting
Waldkrankenhaus St. Marien -Urologische Universitätsklinik | Erlangen, 91054, Germany Not yet recruiting
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus | Frankfurt Am Main, 60431, Germany Recruiting
Universitatsklinikum Frankfurt | Frankfurt am Main, 60590, Germany Recruiting
Klinikum Herne - Urologie | Herne, 44625, Germany Recruiting
Matthias Schulze - Germany | Markkleeberg, 04416, Germany Recruiting
Universitätsklinikum Münster | Münster, 48149, Germany Recruiting
Klinikum Nürnberg Nord - Hautklinik | Nürnberg, 90419, Germany Not yet recruiting
Kliniken Nordoberpfalz AG/Klinikum Weiden | Weiden, 92637, Germany Withdrawn
Alexandra General Hospital of Athens | Athens, 11528, Greece Not yet recruiting
Attikon University General Hospital of Attica | Athens, 12462, Greece Withdrawn
Metropolitan General A.E. | Holargos, 155 62, Greece Recruiting
University Hospital Of Larissa | Larissa, 41110, Greece Not yet recruiting
Hygeia Diagnostic & Therapeutic Center Of Athens | Marousi, 151 23, Greece Not yet recruiting
Athens Medical Center | Maroussi, 151 25, Greece Recruiting
Metropolitan Hospital | Neo Faliro, 18547, Greece Recruiting
Bioclinic - Thessaloniki | Thessaloniki, 546 22, Greece Recruiting
Euromedica General Clinic | Thessaloniki, 54645, Greece Recruiting
Interbalkan Medical Center of Thessaloniki | Thessaloniki, 57001, Greece Not yet recruiting
'Papageorgiou' General Hospital of Thessaloniki | Thessaloniki, TK 56403, Greece Not yet recruiting
Anassa General Clinic | Volos, 38333, Greece Recruiting
Orszagos Onkologiai Intezet | Budapest N/a, 1122, Hungary Not yet recruiting
Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, 1062, Hungary Not yet recruiting
Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Budapest, 1204, Hungary Not yet recruiting
Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary Recruiting
Petz Aladar Megyei Oktato Korhaz | Gyõr, 9023, Hungary Withdrawn
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz | Nyíregyháza, 4400, Hungary Recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs, 7623, Hungary Withdrawn
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet | Szolnok, 5004, Hungary Withdrawn
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation | Amravati, 400601, India Recruiting
Acharya Tulsi Regional Cancer Treatment Research Institute | Bikaner, 334 003, India Not yet recruiting
Post Graduate Institute of Medical Education & Research (PGIMER) | Chandigarh, 160012, India Not yet recruiting
Birla Cancer Centre | Jaipur, 302004, India Not yet recruiting
Shatabdi Super Speciality Hospital | Nashik, 422005, India Recruiting
BLK Super Specialty Hospital | New Delhi, 110005, India Not yet recruiting
Aakash Healthcare Super Speciality Hospital | New Delhi, 110075, India Not yet recruiting
Rajiv Gandhi Cancer Institute & Research Centre | New Delhi, 110085, India Recruiting
Indira Gandhi Institute of Medical Sciences | Patna, 800014, India Not yet recruiting
Jehangir Clinical Development Center Pvt Ltd | Pune, 411001, India Recruiting
Hillel Yaffe Medical Center | Hadera, 3810101, Israel Withdrawn
Rambam Health Care Campus | Haifa, 3109601, Israel Withdrawn
Hadassah University Hospita - Ein Kerem | Jerusalem, 9112001, Israel Withdrawn
Ziv Medical Center | Safed, 13100, Israel Withdrawn
Tel Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel Withdrawn
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Bari, 70120, Italy Not yet recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Bari, 70124, Italy Not yet recruiting
Fondazione del Piemonte per I'Oncologia IRCC Candiolo | Candiolo, 10060, Italy Not yet recruiting
SPDC Villa Scassi | Genova, 16100, Italy Recruiting
Ospedale San Martino | Genova, 16132, Italy Recruiting
Ospedale S. Maria della Scaletta | Imola, 40026, Italy Not yet recruiting
Istituto Europeo di Oncologia | Milano, 20141, Italy Not yet recruiting
Ospedale San Raffaele | Milan, 20132, Italy Not yet recruiting
Istituto Oncologico Veneto - IRCCS | Padova, 35128, Italy Withdrawn
Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani | Pagani, 84016, Italy Recruiting
Azienda Ospedaliero Universitaria Pisana | Pisa, 56126, Italy Not yet recruiting
ASL Napoli 2 Nord-SM delle Grazie Hospital | Pozzuoli, 80078, Italy Recruiting
Policlinico Universitario Agostino Gemelli | Roma, 00168, Italy Recruiting
Azienda Ospedaliera Sant Andrea | Roma, 00189, Italy Recruiting
Istituto Nazionale Tumori Regina Elena | Rome, 00144, Italy Recruiting
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino | Torino, 10126, Italy Not yet recruiting
Ospedale di Circolo e Fondazione Macchi | Varese, 21100, Italy Recruiting
Ospedale San Bortolo | Vicenza, 36100, Italy Recruiting
Aso Co.,Ltd Iizuka Hospital | Iizuka, 820-8501, Japan Recruiting
St.Marianna University School of Medicine | Kanagawa, 216-8511, Japan Recruiting
Nara Medical University Hospital | Kashihara, 634-8522, Japan Recruiting
Saitama Medical University Hospital | Kawagoe-Shi, 350-8550, Japan Recruiting
Kimitsu Chuo Hospital | Kisarazu, 292-8535, Japan Recruiting
National Hospital Organization Kumamoto Medical Center | Kumamoto, 860-0008, Japan Withdrawn
Nagasaki University Hospital | Nagasaki, 852-8501, Japan Recruiting
JOHAS Osaka Rosai Hospital | Osaka, 591-8025, Japan Recruiting
Sagamihara Kyodo Hospital | Sagamihara-Shi, 252-0253, Japan Withdrawn
Tokuyama Central Hospital | Shunan, 745-8522, Japan Recruiting
Toranomon Hospital | Tokyo, 105-8470, Japan Recruiting
Fujita Health University Hospital | Toyoake, 470-1192, Japan Recruiting
Yamaguchi University Hospital | Ube, 755-8505, Japan Recruiting
Yokohama City University Medical Center | Yokohama, 232-0024, Japan Recruiting
Inje University Haeundae Paik Hospital | Busan, 612-896, Korea, Republic of Recruiting
Kyungpook National University Chilgok Hospital | Daegu, 41404, Korea, Republic of Recruiting
Keimyung University Dongsan Hospital | Daegu, 42601, Korea, Republic of Recruiting
National Cancer Center | Goyang-si, 10408, Korea, Republic of Recruiting
Gachon University Gil Medical Center | Namdong, 405 760, Korea, Republic of Recruiting
Seoul National University Hospital | Seoul, 03080, Korea, Republic of Recruiting
Severance Hospital | Seoul, 03722, Korea, Republic of Recruiting
Gangnam Severance Hospital | Seoul, 06273, Korea, Republic of Not yet recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul, 06591, Korea, Republic of Recruiting
Pusan National University Yangsan Hospital | Yangsan-si, 50612, Korea, Republic of Recruiting
CRYPTEX Investigacion clinica S.A De C.V | Ciudad de México, 06100, Mexico Withdrawn
Oncología Integral Satelite | Ciudad de México, 06720, Mexico Not yet recruiting
Consultorio Privado Dr Jose Arturo Rodriguez Rivera | Guadalajara, 45050, Mexico Recruiting
Centro De Estudio Y Prevencion Del Cancer | Juchitan De Zaragoza, 70000, Mexico Recruiting
Dr. Marco Antonio Badillo Santoyo | Leon, 37000, Mexico Recruiting
i Can Oncology Center | Monterrey, 64710, Mexico Recruiting
Centro de Investigacion Clinica Chapultepec | Morelia, 58260, Mexico Recruiting
Oncológico Potosino | San Luis Potosi, 78250, Mexico Recruiting
Investigación Biomedica para el desarrollo de Farmacos, S.A. de C.V. | Zapopan, 45070, Mexico Recruiting
The Julius Center - Utrecht Science Park - Stratenum | Utrecht, 3508 GA, Netherlands Withdrawn
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy | Bydgoszcz, 85-168, Poland Withdrawn
Uniwersytet Medyczny w Lublinie - Katedra i Klinika Urologii i Onkologii Urologicznej | Lublin, 20-090, Poland Withdrawn
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego | Lublin, 20-718, Poland Not yet recruiting
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II | Siedlce, 08-110, Poland Recruiting
Centrum Medyczne Pratia Poznan | Skorzewo, 60-185, Poland Recruiting
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka, | Słupsk, 76-200, Poland Withdrawn
Centralny Szpital Kliniczny MSWiA w Warszawie | Warszawa, 02-507, Poland Recruiting
NZOZ Szpital Mazovia | Warszawa, 02-797, Poland Withdrawn
Uniwersytecki Szpital Kliniczny | Wroclaw, 50556, Poland Not yet recruiting
Hospital Garcia de Orta | Almada, 2805-267, Portugal Not yet recruiting
Centro Hospitalar e Universitario de Coimbra | Coimbra, 3000075, Portugal Recruiting
Centro Hospitalar de Lisboa Central | Lisboa, 1150-199, Portugal Not yet recruiting
H. Santa Maria - Centro Hospitalar de Lisboa Norte | Lisboa, 1649-035, Portugal Recruiting
Fundação Champalimaud | Lisbon, 1400-038, Portugal Not yet recruiting
Hospital de Sao Joao | Porto, 4200-319, Portugal Recruiting
Centro Hospitalar de Trás os Montes e Alto-Douro | Vila Real, 5000508, Portugal Not yet recruiting
Altlay Regional Oncology Dispensary | Barnaul, 656045, Russian Federation Recruiting
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine | Chelyabinsk, 454087, Russian Federation Not yet recruiting
Ivanovo Regional Oncology Dispensary | Ivanovo, 153040, Russian Federation Recruiting
Krasnoyarsk Regional Oncology Dispensary | Krasnoyarsk, 660133, Russian Federation Recruiting
N. N. Blokhin Russian Academy of Medical Sciences | Moscow, 115478, Russian Federation Not yet recruiting
Hertzen Oncology Research Institute | Moscow, 125284, Russian Federation Recruiting
Moscow City Oncology Hospital № 62 | Moscow, 143423, Russian Federation Not yet recruiting
A. Tsyb Medical Radiological Research Center | Obninsk, 249031, Russian Federation Recruiting
BHI of Omsk region Clinical Oncology Dispensary | Omsk, 644013, Russian Federation Recruiting
Hospital for War Veterans | Rostov, 344037, Russian Federation Not yet recruiting
Ryazan State Medical University named after I.P.Pavlov | Ryazan, 390011, Russian Federation Recruiting
City Multiple-Discipline Hospital # 2 | Saint Petersburg, 192174, Russian Federation Not yet recruiting
FSBHI RSCRST n.a. Ac. Granov A.M. of MoH | Saint Petersburg, 197758, Russian Federation Not yet recruiting
N.N. Petrov Research Institute Of Oncology | Saint Petersburg, 197758, Russian Federation Recruiting
N.N. Petrov Research Institute Of Oncology | Saint Petersburg, 197758, Russian Federation Not yet recruiting
Leningrad Regional Oncology Dispensary | Saint-Petersburg, 191104, Russian Federation Withdrawn
Severo-Zapadnyy Gosudarstvennyy Meditsinskiy Universitet Im. I. I. Mechnikova | Sankt-Peterburg, 195067, Russian Federation Withdrawn
Ogarev Mordovian State University | Saransk, 430005, Russian Federation Recruiting
State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio | Sochi, 354057, Russian Federation Recruiting
Multifunctional clinical medical center 'Medical city' | Tyumen, 625041, Russian Federation Recruiting
Bashkir State Medical University | Ufa, 450008, Russian Federation Recruiting
Charlotte Maxeke Johannesburg Academic Hospital | Johannesburg, 2193, South Africa Not yet recruiting
Life Wilgers Hospital | Pretoria, 0041, South Africa Withdrawn
Hosp. Univ. A Coruña | A Coruña, 15006, Spain Withdrawn
Hosp. Univ. Germans Trias I Pujol | Badalona, 08916, Spain Not yet recruiting
Fundacion Puigvert | Barcelona, 08025, Spain Not yet recruiting
Hosp. Univ. Vall D Hebron | Barcelona, 8035, Spain Not yet recruiting
Hosp. Puerta Del Mar | Cadiz, 11009, Spain Not yet recruiting
Hosp. Univ. Virgen de Las Nieves | Granada, 18014, Spain Not yet recruiting
Hosp. de Jerez de La Frontera | Jerez de la Frontera, 11407, Spain Not yet recruiting
Clinica Univ. de Navarra | Madrid, 28027, Spain Not yet recruiting
Hosp. Univ. 12 de Octubre | Madrid, 28041, Spain Not yet recruiting
Hosp. Univ. de La Paz | Madrid, 28046, Spain Not yet recruiting
Hosp. Univ. Hm Monteprincipe | Madrid, 28660, Spain Not yet recruiting
Hosp. Virgen de La Victoria | Málaga, 29010, Spain Not yet recruiting
Hosp. Univ. Son Espases | Palma de Mallorca, 07122, Spain Not yet recruiting
Corporacio Sanitari Parc Tauli | Sabadell, 08208, Spain Not yet recruiting
Hosp. Univ. Infanta Sofia | San Sebastián De Los Reyes, 28702, Spain Not yet recruiting
Hosp. Univ. Marques de Valdecilla | Santander, 39008, Spain Not yet recruiting
Instituto Valenciano de Oncologia | Valencia, 46009, Spain Not yet recruiting
Hosp. Clinico Univ. de Valencia | Valencia, 46010, Spain Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung, 807, Taiwan Recruiting
China Medical University Hospital | Taichung, 40447, Taiwan Recruiting
Taichung Veterans General Hospital | Taichung, 407, Taiwan Recruiting
National Cheng Kung University Hospital | Tainan, 70403, Taiwan Recruiting
National Taiwan University Hospital | Taipei City, 10048, Taiwan Recruiting
Tri-Service General Hospital | Taipei, 11490, Taiwan Recruiting
Chang Gung Memorial Hospital Linkou Branch | Taoyuan, 333, Taiwan Recruiting
Adana Baskent Yuregir Hospital | Adana, Turkey Not yet recruiting
Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital | Ankara, 06050, Turkey Not yet recruiting
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi | Ankara, 06100, Turkey Not yet recruiting
Dokuz Eylul Universitesi Tip Fakultesi | Balcova, 35330, Turkey Not yet recruiting
Bezmialem University Medical Faculty | Fatih, 34093, Turkey Not yet recruiting
Medical Park Gaziantep Hastanesi | Gaziantep, 27584, Turkey Not yet recruiting
Istanbul University Cerrahpasa Medical Faculty | Istanbul, 34096, Turkey Not yet recruiting
Istanbul Medeniyet University Goztepe Training and Research Hospital | Istanbul, 34732, Turkey Not yet recruiting
Office Of Ahmet Cag Cal, MD | Izmir, 35110, Turkey Not yet recruiting
Izmir Medical Park Hospital | Izmir, 35530, Turkey Not yet recruiting
Inonu University Medical Faculty | Malatya, 44280, Turkey Not yet recruiting
Erciyes Univ MKD Hospital | Melikgazi, 38039, Turkey Not yet recruiting
T.C. Saglik Bakanligi Ankara Numune Egitim ve Arastirma Hastanesi | Seyhan, 01330, Turkey Not yet recruiting
Chernihivskyi oblasnyi onkolohichnyi dyspanser | Chernihiv, 14029, Ukraine Recruiting
Chernivtsi Regional Clinical Hospital | Chernivtsi, 58000, Ukraine Withdrawn
SE Dnipropetrovsk Medical Academy | Dnipro, 49005, Ukraine Recruiting
MIH V.I. Shapoval Regional Clinical Centre of Urology and Nephrology | Kharkiv, 61037, Ukraine Withdrawn
Kharkiv Regional Clinical Hospital | Kharkiv, 61070, Ukraine Recruiting
Khersonsky Regional Oncology Center | Kherson, 73000, Ukraine Recruiting
Main Military Clinical Hospital of MDU | Kiev, 01133, Ukraine Withdrawn
Asklepion LLC | Kiev, 08173, Ukraine Recruiting
Krivorizhskiy Oncology Dispensary | Kriviy Rih, 50048, Ukraine Withdrawn
Oleksandrivska Clinical Hospital of Kyiv City, Infectional Department #2 | Kyiv, 01601, Ukraine Withdrawn
Kyiv City Clinical Hospital #3 | Kyiv, 02660, Ukraine Recruiting
State Institution Academy Of Medical Sciences Of Ukraine | Kyiv, 04053, Ukraine Recruiting
P.L. Shupyk National Medical Academy of Post-Graduate Education | Kyiv, 04112, Ukraine Recruiting
Lviv Regional Clinical Hospital | Lviv, 79000, Ukraine Recruiting
Odeska miska klinichna likarnya No10 | Odessa, 65000, Ukraine Withdrawn
Sumy Regional Clinical Oncology Centre | Sumy, 40022, Ukraine Not yet recruiting
Расположение Страны

Argentina

Australia

Austria

Belgium

Brazil

Canada

China

Czechia

France

Germany

Greece

Hungary

India

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Poland

Portugal

Russian Federation

South Africa

Spain

Taiwan

Turkey

Ukraine

United States

Дата проверки

2022-01-01

Ответственная сторона

Тип: Спонсор

Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: TAR-200 + Cetrelimab

Тип: Experimental

Описание: Participants will receive intravesical TAR-200 every 3 weeks (21 days indwelling) for first 18 weeks and thereafter from Week 24 every 12 weeks through study Year 3 in combination with Cetrelimab.

Метка: Химиотерапия (цисплатин или гемцитабин) + лучевая терапия

Тип: Активный компаратор

Описание: Участники будут получать химиотерапию по выбору исследователя: либо цисплатин внутривенно один раз в неделю в течение 6 недель лечения, либо гемцитабин внутривенно два раза в неделю в течение 6 недель лечения в качестве стандарта лечения (SOC) вместе с лучевой терапией либо обычной лучевой терапией (64 Грея [Гр], мочевой пузырь только) до 6,5 недель лечения или гипофракционированная лучевая терапия (55 Гр, только мочевой пузырь) до 4 недель.

Акроним SunRISe-2
Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное назначение

Первичное назначение: Уход

Маскировка: Нет (открытая этикетка)