Исследование TAR-200 в сочетании с цетрелимабом, одним TAR-200 на пациентах с немышечно-инвазивным раком мочевого пузыря (NMIBC), не отвечающими на внутрипузырную бацил Кальлуметта-Герена, которые не соответствуют критериям радикальной цистэктомии или былираны для этого.

Название протокола
Клинические исследование Новообразования мочевого пузыря: TAR-200, Цетрелимаб - 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

Целью данного исследования является оценка общего показателя полного ответа (ПО) у пациентов. участники, получавшие TAR-200 в комбинации с цетрелимабом (когорта 1) или только TAR-200 (Когорта 2) или цетрелимаб отдельно (Когорта 3) с карциномой in situ (CIS), с или без сопутствующая папиллярная болезнь Та или Т1 высокой степени.

Подробное описание

Рак мочевого пузыря является десятым по распространенности типом рака во всем мире. Естественная история неинвазивный рак мочевого пузыря высокого риска (HR-NMIBC) непредсказуем; частота повторения изменяются от 15 процентов (%) до 78%, скорость прогресса до мышечной инвазии и метастазов изменяться от менее чем (

Общий статус Рекрутинг
Дата начала 2020-12-18
Дата завершения 2027-07-02
Дата первичного завершения 2024-10-24
Фаза Фаза 2
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Частота общего клинического ответа (CR) До 5 лет
Вторичный результат
Мера Временное ограничение
Duration of Response (DOR) Up to 5 years
Общее выживание (ОС) До 5 лет
Когорта 1 и 2: концентрации гемцитабина и 2 ', 2' дифтордезоксиуридина (dFdU) в моче и плазме До 21 недели
Когорта 1 и 3: Концентрация антител к цетрелимабу в сыворотке Передозировка, до 3-х лет
Количество участников с антителами к цетрелимабу Передозировка, до 3-х лет
Изменение по сравнению с исходным уровнем в опроснике качества жизни Европейской организации по исследованию и лечению рака (EORTC QLQ) - баллы C30 Исходный уровень, до 3 лет и 4 месяцев
Изменение по сравнению с исходным уровнем в EORTC QLQ - немышечно-инвазивный рак мочевого пузыря (NMIBC) 24 балла Исходный уровень, до 3 лет и 4 месяцев
Количество участников с нежелательными явлениями (НЯ) по степени тяжести До 5 лет
Регистрация 200
Состояние
  • Новообразования мочевого пузыря
Вмешательство

Тип вмешательства: Drug

Название вмешательства: TAR-200

Описание: TAR-200 will be administered transuretherally.

Тип вмешательства: Биологические

Название вмешательства: Цетрелимаб

Описание: Будет назначен цетрелимаб.

Другое имя: JNJ-63723283

Приемлемость

Критерии:

Критерии включения: - Гистологически подтвержденный диагноз постоянного или рецидивирующего высокого риска, немышечного Инвазивный рак мочевого пузыря (HR-NMIBC) (карцинома in situ [CIS]; опухоль in situ [Tis]), с или без папиллярной болезни (T1, Ta высокой степени) в течение 12 месяцев после завершения (последняя доза) адекватной терапии Bacillus Calmette-Guerin (БЦЖ). Смешанная гистология опухоли разрешены, если дифференцировка уротелия (гистология переходных клеток) преобладающий (например, меньше чем (

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

N / A

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Janssen Research & Development, LLC Clinical Trial 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
Urological Associates of Southern Arizona, P.C. | Tucson, Arizona, 85715, United States Recruiting
University of Southern California | Los Angeles, California, 90033, United States Recruiting
The Urology Center of Colorado | Denver, Colorado, 80211, United States Recruiting
Foothills Urology - Golden Off | Golden, Colorado, 80401, United States Recruiting
DuPage Medical Group | Lisle, Illinois, 60532, United States Recruiting
Indiana University | Indianapolis, Indiana, 46202-5116, United States Withdrawn
Johns Hopkins Medical Institutions | Baltimore, Maryland, 21287, United States Withdrawn
University of Michigan | Ann Arbor, Michigan, 48109-5000, United States Withdrawn
Wayne State University | Detroit, Michigan, 48202, United States Withdrawn
NYU Langone Health | New York, New York, 10017, United States Not yet recruiting
University of Rochester | Rochester, New York, 14627, United States Withdrawn
SUNY Upstate Medical University | Syracuse, New York, 13210-2375, United States Recruiting
Associated Medical Professionals | Syracuse, New York, 13210, United States Not yet recruiting
Levine Cancer Institute | Charlotte, North Carolina, 28204, United States Recruiting
Wake Forest Health Sciences | Winston-Salem, North Carolina, 27103, United States Withdrawn
Oregon Urology Institute | Springfield, Oregon, 97477, United States Withdrawn
Urologic Consultants of Southeastern Pennsylvania | Bala-Cynwyd, Pennsylvania, 19004, United States Recruiting
Thomas Jefferson University | Philadelphia, Pennsylvania, 19107, United States Not yet recruiting
Urology Associates, PC | Nashville, Tennessee, 37209, United States Recruiting
Vanderbilt University Medical Center | Nashville, Tennessee, 37232, United States Recruiting
University of Texas Southwestern Medical Center | Dallas, Texas, 75390, United States Not yet recruiting
Urology San Antonio Research | San Antonio, Texas, 78229, United States Recruiting
Spokane Urology | Spokane, Washington, 99202, United States Recruiting
Flinders Medical Centre | Bedford Park, 5042, Australia Recruiting
Eastern Health Research | Box Hill, 3128, Australia Recruiting
Prince Of Wales Hospital | Randwick, 2031, Australia Not yet recruiting
Royal North Shore Hospital | St Leonards, 2065, Australia Not yet recruiting
Macquarie University Hospital | Sydney, 2109, Australia Recruiting
Princess Alexandra Hospital | Woolloongabba, 4102, Australia Withdrawn
Algemeen Ziekenhuis Sint-Jan | Assebroek, 8310, Belgium Not yet recruiting
AZ St.-Jan Brugge-Oostende AV | Brugge, 8000, Belgium Recruiting
Hopital Erasme | Brussel, 1070, Belgium Recruiting
Universitair Ziekenhuis Gent | Gent, 9000, Belgium Recruiting
Algemeen Ziekenhuis Delta | Roeselare, 8800, Belgium Recruiting
AZ Nikolaas | Sint-Niklaas, 9100, Belgium Recruiting
Exdeo Clinical Research Inc | Abbotsford, British Columbia, V2S 3N5, Canada Not yet recruiting
The Male/Female Health and Research Centre | Barrie, Ontario, L4M 7G1, Canada Not yet recruiting
Princess Margaret Hospital- UHN | Toronto, Ontario, M5G 2M9, Canada Not yet recruiting
McGill University Health Centre | Montreal, Quebec, H4A 3J1, Canada Not yet recruiting
Universite de Sherbrooke | Sherbrooke, Quebec, J1H 5H3, Canada Not yet recruiting
Polyclinique Bordeaux Nord Acquitaine | Bordeaux, 33300, France Recruiting
Hôpital Côte de Nacre | Caen cedex 9, 14033, France Withdrawn
CHU Grenoble | Grenoble, 38043, France Recruiting
Clinique Sainte Marguerite | Hyeres, 83400, France Recruiting
Polyclinique de Limoges - Francois Chenieux | Limoges, 87000, France Recruiting
Hôpital Edouard Herriot | Lyon Cedex 03, 69437, France Not yet recruiting
Institut Paoli-Calmettes | Marseille, 13273, France Recruiting
CHU Nîmes | Nimes, 30029, France Recruiting
Hôpital Universitaire Pitié-Salpêtrière | Paris Cedex 13, 75013, France Recruiting
Hopital Saint-Louis | Paris, 75010, France Not yet recruiting
Hopital Europeen Georges-Pompidou | Paris, 75015, France Recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon | Paris, 75020, France Not yet recruiting
Hopital Bichat Claude Bernard | Paris, 75877, France Recruiting
CHU De Poitiers | Poitiers, 86021, France Withdrawn
Hopital Pontchaillou | Rennes cedex 9, 35033, France Not yet recruiting
CHP Saint Gregoire | Saint Gregoire, 35760, France Recruiting
Institut de Cancérologie Strasbourg Europe (ICANS) | Strasbourg, 67200, France Recruiting
Hopital Foch | Suresnes, 92151, France Recruiting
Urologicum Duisburg | Duisburg, 47179, Germany Not yet recruiting
Klinikum Herne - Urologie | Herne, 44625, Germany Recruiting
Uniklinik Köln | Köln, 50937, Germany Not yet recruiting
Urologische Partnerschaft Köln UPK | Köln, 50968, Germany Recruiting
Matthias Schulze - Germany | Markkleeberg, 04416, Germany Recruiting
Urologie Neandertal Praxis Mettmann | Mettmann, 40822, Germany Recruiting
Universitätsklinikum Münster | Münster, 48149, Germany Recruiting
Schön Klinik Nürnberg Fürth | Nürnberg, 90491, Germany Not yet recruiting
Studienpraxis Urologie Nürtingen - Germany | Nürtingen, 72622, Germany Recruiting
Kliniken Nordoberpfalz AG/Klinikum Weiden | Weiden, 92637, Germany Withdrawn
Urologische Praxis am Wasserturm - Germany | Würselen, 52146, Germany Recruiting
Attikon University General Hospital of Attica | Athens, 12462, Greece Withdrawn
Metropolitan General A.E. | Holargos, 155 62, Greece Not yet recruiting
Athens Medical Center | Maroussi, 151 25, Greece Recruiting
Bioclinic - Thessaloniki | Thessaloniki, 546 22, Greece Recruiting
General Hospital of Thessaloniki G. Gennimatas | Thessaloniki, 54635, Greece Not yet recruiting
Euromedica General Clinic | Thessaloniki, 54645, Greece Not yet recruiting
'Papageorgiou' General Hospital of Thessaloniki | Thessaloniki, TK 56403, Greece Not yet recruiting
Policlinico Abano Terme | Abano Terme, 35031, Italy 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
Azienda Ospedaliera Universitaria Careggi | Firenze, 50135, Italy Not yet recruiting
Ospedale San Martino | Genova, 16132, Italy Not yet recruiting
Ospedale San Raffaele | Milan, 20132, Italy Not yet recruiting
Azienda Ospedaliero Universitaria Pisana | Pisa, 56126, Italy Not yet recruiting
Azienda Ospedaliera Sant Andrea | Roma, 00189, Italy Recruiting
Istituto Nazionale Tumori Regina Elena | Rome, 00144, Italy Terminated
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 Not yet 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
Kimitsu Chuo Hospital | Kisarazu, 292-8535, Japan Recruiting
Nagasaki University Hospital | Nagasaki, 852-8501, Japan Recruiting
JOHAS Osaka Rosai Hospital | Osaka, 591-8025, Japan Recruiting
Toranomon Hospital | Tokyo, 105-8470, Japan Recruiting
Toyama University Hospital | Toyama-shi, 930-0194, Japan Recruiting
Fujita Health University Hospital | Toyoake, 470-1192, Japan Recruiting
University of Tsukuba Hospital | Tsukuba-Shi, 305-8520, Japan Recruiting
Yamaguchi University Hospital | Ube, 755-8505, Japan Withdrawn
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 Not yet recruiting
Chonnam National University Hospital | Gwangju, 61469, 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 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
Noordwest Ziekenhuisgroep | Alkmaar, 1800 AM, Netherlands Withdrawn
NKI-AVL, Amsterdam | Amsterdam, 1066 CX, Netherlands Not yet recruiting
Catharina Ziekenhuis | Eindhoven, 5623EJ, Netherlands Recruiting
Canisius-Wilhelmina Ziekenhuis | Nijmegen, 6532SZ, Netherlands Not yet recruiting
The Julius Center - Utrecht Science Park - Stratenum | Utrecht, 3508 GA, Netherlands Recruiting
Hospital Garcia de Orta | Almada, 2805-267, Portugal Recruiting
Chbv - Hosp. Infante D. Pedro | Aveiro, 3810-193, Portugal Not yet recruiting
Hospital da Senhora da Oliveira | Guimarães, 4835-044, Portugal Recruiting
Centro Hospitalar de Lisboa Central | Lisboa, 1150-199, Portugal Not yet recruiting
Fundação Champalimaud | Lisbon, 1400-038, Portugal Not yet recruiting
Hospital Beatriz Angelo | Loures, 2674-514, Portugal Not yet recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil | Porto, 4200-072, Portugal Not yet recruiting
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. | Vila Nova de Gaia, 4434-502, Portugal Recruiting
Centro Hospitalar de Trás os Montes e Alto-Douro | Vila Real, 5000508, Portugal Recruiting
N. N. Blokhin Russian Academy of Medical Sciences | Moscow, 115478, Russian Federation Not yet recruiting
Hertzen Oncology Research Institute | Moscow, 125284, Russian Federation Not yet recruiting
City Clinical Hospital #1 | Nizhny Novgorod, 603109, Russian Federation Recruiting
Avicenna Medical Center | Novosibirsk, 630099, 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 Not yet recruiting
Ultrasound Clinic 4D | Pyatigorsk, 357502, Russian Federation Recruiting
Hospital for War Veterans | Rostov-on-Don, 344037, Russian Federation Not yet 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 Withdrawn
City Pokrovskaya Hospital | Sankt-Peterburg, 199106, Russian Federation Not yet recruiting
Saratov State Medical University | Saratov, 410054, Russian Federation Recruiting
Multifunctional clinical medical center 'Medical city' | Tyumen, 625041, Russian Federation Recruiting
Bashkir State Medical University | Ufa, 450008, Russian Federation Recruiting
Hosp. Univ. A Coruña | A Coruña, 15006, Spain Not yet recruiting
Hosp. Univ. Germans Trias I Pujol | Badalona, 08916, Spain Not yet recruiting
Fundacion Puigvert | Barcelona, 08025, Spain Not yet recruiting
Hosp. Clinic I Provincial de Barcelona | Barcelona, 08036, 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
Hosp. Univ. Ramon Y Cajal | Madrid, 28034, Spain Not yet recruiting
Hosp. Univ. 12 de Octubre | Madrid, 28041, Spain Not yet recruiting
Hosp. Univ. 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
Corporacio Sanitari Parc Tauli | Sabadell, 08208, Spain Not yet recruiting
Instituto Valenciano de Oncologia | Valencia, 46009, Spain 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, 06590, Turkey Not yet recruiting
Trakya University Medical Faculty | Edirne, 22130, 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, 44000, Turkey Not yet recruiting
Cherkassy Regional Oncology Dispensary, Department of Hematology | Cherkasy, 18009, Ukraine Withdrawn
Chernihivskyi oblasnyi onkolohichnyi dyspanser | Chernihiv, 14029, Ukraine Recruiting
Chernivtsi Regional Clinical Hospital | Chernivtsi, 58000, Ukraine Withdrawn
SE Dnipropetrovsk Medical Academy | Dnipro, 49005, Ukraine Withdrawn
Main Military Clinical Hospital of MDU | Kiev, 01133, Ukraine Withdrawn
Asklepion LLC | Kiev, 08173, Ukraine Recruiting
Kyiv City Clinical Hospital #3 | Kyiv, 02660, Ukraine Withdrawn
State Institution Academy Of Medical Sciences Of Ukraine | Kyiv, 04053, Ukraine Withdrawn
Lviv Regional Clinical Hospital | Lviv, 79000, Ukraine Withdrawn
Odeska miska klinichna likarnya No10 | Odessa, 65000, Ukraine Withdrawn
Sumy Regional Clinical Oncology Centre | Sumy, 40022, Ukraine Recruiting
NHS Greater Glasgow and Clyde | Glasgow, G12 0YN, United Kingdom Not yet recruiting
East and North Hertfordshire NHS Trust | Hertfordshire, SG1 4AB, United Kingdom Not yet recruiting
Leeds Teaching Hospitals NHS Trust | Leeds, LS9 7TF, United Kingdom Not yet recruiting
Guys' and St Thomas' NHS Trust | London, SE1 9RT, United Kingdom Withdrawn
The Christie Nhs Foundation Trust | Manchester, M20 4BX, United Kingdom Not yet recruiting
Oxford University Hospitals NHS Foundation Trust | Oxford, OX3 7LE, United Kingdom Withdrawn
Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield, S10 2 JF, United Kingdom Not yet recruiting
The Clatterbridge Cancer Centre | Wirral, CH63 4JY, United Kingdom Withdrawn
Расположение Страны

Australia

Belgium

Canada

France

Germany

Greece

Italy

Japan

Korea, Republic of

Netherlands

Portugal

Russian Federation

Spain

Turkey

Ukraine

United Kingdom

United States

Дата проверки

2021-10-01

Ответственная сторона

Тип: Спонсор

Имеет расширенный доступ Нет
Количество рук 3
Группа вооружений

Метка: Cohort 1: TAR-200 and Cetrelimab

Тип: Experimental

Описание: TAR-200 is placed into the bladder through a urinary placement catheter on Day 0 and will be dosed every 21 days for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Study Year 2). In addition, Cetrelimab will be dosed every 3 weeks (Q3W) through Week 78 (18 months).

Метка: Когорта 2: TAR-200.

Тип: Экспериментальный

Описание: TAR-200 вводится в мочевой пузырь через мочевой катетер в день 0 и будет вводиться каждые 21 день в течение первых 24 недель (6 месяцев), затем каждые 12 недель до недели 99 (год исследования 2).

Метка: Когорта 3: Цетрелимаб

Тип: Экспериментальный

Описание: Участники получат цетрелимаб, который будет вводиться Q3W до недели 78 (18 месяцев).

Акроним SunRISe-1
Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Нет (открытая этикетка)