Клинические исследование Muscle Invasive Bladder Cancer: Durvalumab, Tremelimumab, Enfortumab Vedotin, Radical Cystectomy

Спонсоры	Ведущий спонсор: AstraZeneca
Источник	AstraZeneca
Краткое содержание	A Global Study to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer

Подробное описание

Not provided

Общий статус

Recruiting

Дата начала

2021-08-05

Дата завершения

2028-09-08

Дата первичного завершения

2025-07-18

Фаза

Phase 3

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Safety and Tolerability as evaluated by adverse events occurring throughout the study	At completion of study treatment by the last patient and at 3 months.
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (blood pressure in mmHg)	Up to 84 months
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed ssessed by vital signs (pulse rate) in beats per minute	Up to 84 months
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (respiration rate) in breaths per minute	Up to 84 months
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by vital signs (temperature) in degrees Celsius	Up to 84 months
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by liver function	Up to 84 months
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by kidney function	Up to 84 months
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in clinical chemistry by thyroid function	Up to 84 months
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by abnormality in haematology	Up to 84 months
Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin as assessed by ECG (pulse rate)	Up to 84 months
Changes in WHO/ECOG performance status	Up to 84 months
Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on pCR rate	Up to 3 years
Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on EFS	Up to 3 years

Вторичный результат

Мера	Временное ограничение
1.Pathologic complete response (pCR) rates at time of cystectomy in Arm 2 vs Arm 3	3 years
2.Event-free survival (EFS) defined as time from randomization to event in Arm 2 vs Arm 3	Up to 5 years
3.Overall survival	Up to 5 years
4.EFS at 24 months (EFS24)	Up to 24 months
5.Overall survival rate at 5 years	At 5 years
6.Disease-free survival (DFS)	Up to first recurrence of disease or death up to 5 years
7.Pathologic downstaging (pDS) rate-to < pT2	3 years
8.Disease-specific survival (DSS)	from randomization until death due to bladder cancer up to 5 year.
9.EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire)	from baseline and time to definitive clinically, assessed up to 5 years
10.Immunogenicity of durvalumab when used in combination with Tremelimumab as measured by presence of antidrug antibodies (ADA)	At 3 months after last dose of durvalumab and tremelimumab
11.Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab and tremelimumab	At 3 months after last dose of durvalumab and tremelimumab
11.Time to maximum observed serum concentration (tmax) of durvalumab and tremelimumab	At 3 months after last dose of durvalumab and tremelimumab

Регистрация

830

Состояние	Muscle Invasive Bladder Cancer
Вмешательство	Тип вмешательства: Drug Название вмешательства: Durvalumab Описание: Anti- PD-L1 Antibody Тип вмешательства: Drug Название вмешательства: Tremelimumab Описание: Human IgG2 mAb Этикетка Arm Group: Durvalumab + Tremelimumab + Enfortumab vedotin Тип вмешательства: Drug Название вмешательства: Enfortumab Vedotin Описание: Nectin-4-directed antibody and microtubule inhibitor conjugate Другое имя: PADCEV Тип вмешательства: Procedure Название вмешательства: Radical Cystectomy Описание: For cisplatin-ineligible patients
Приемлемость	Критерии: Inclusion Criteria: - Histologically or cytologically documented muscle-invasive TCC of the bladder with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology; - Medically fit for cystectomy and able to receive neoadjuvant therapy; - Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC; - ECOG performance status of 0,1,2 at enrollment. - Availability of tumor sample prior to study entry; - Must have a life expectancy of at least 12 weeks at randomization. Exclusion criteria: - Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening. - Active infection - Uncontrolled intercurrent illness - Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies. - Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs. Пол: All Минимальный возраст: 18 Years Максимальный возраст: 130 Years Здоровые волонтеры: No

Состояние

Muscle Invasive Bladder Cancer

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Durvalumab

Описание: Anti- PD-L1 Antibody

Тип вмешательства: Drug

Название вмешательства: Tremelimumab

Описание: Human IgG2 mAb

Этикетка Arm Group: Durvalumab + Tremelimumab + Enfortumab vedotin

Тип вмешательства: Drug

Название вмешательства: Enfortumab Vedotin

Описание: Nectin-4-directed antibody and microtubule inhibitor conjugate

Другое имя: PADCEV

Тип вмешательства: Procedure

Название вмешательства: Radical Cystectomy

Описание: For cisplatin-ineligible patients

Приемлемость

Критерии:

Inclusion Criteria: - Histologically or cytologically documented muscle-invasive TCC of the bladder with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology; - Medically fit for cystectomy and able to receive neoadjuvant therapy; - Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC; - ECOG performance status of 0,1,2 at enrollment. - Availability of tumor sample prior to study entry; - Must have a life expectancy of at least 12 weeks at randomization. Exclusion criteria: - Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening. - Active infection - Uncontrolled intercurrent illness - Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti--PD-1, anti PD-L1, or anti-PD-L2 antibodies. - Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

130 Years

Здоровые волонтеры:

Общий контакт

Фамилия: AstraZeneca Clinical Study Information Center

Телефон: 1-877-240-9479

Расположение

Объект:	Положение дел:
Research Site \| Phoenix, Arizona, 85054, United States	Not yet recruiting
Research Site \| Orange, California, 92868, United States	Not yet recruiting
Research Site \| Santa Monica, California, 90404, United States	Recruiting
Research Site \| Colorado Springs, Colorado, 80909, United States	Not yet recruiting
Research Site \| Washington, District of Columbia, 20010, United States	Not yet recruiting
Research Site \| Coeur d'Alene, Idaho, 83814, United States	Recruiting
Research Site \| Maywood, Illinois, 60153, United States	Not yet recruiting
Research Site \| Indianapolis, Indiana, 46250, United States	Not yet recruiting
Research Site \| Brighton, Michigan, 48114, United States	Not yet recruiting
Research Site \| Detroit, Michigan, 48202, United States	Not yet recruiting
Research Site \| Jackson, Mississippi, 39213, United States	Not yet recruiting
Research Site \| Las Vegas, Nevada, 89102, United States	Recruiting
Research Site \| Brooklyn, New York, 11219, United States	Not yet recruiting
Research Site \| Buffalo, New York, 14263, United States	Recruiting
Research Site \| Syracuse, New York, 13210, United States	Not yet recruiting
Research Site \| Cincinnati, Ohio, 45219, United States	Withdrawn
Research Site \| Portland, Oregon, 97239, United States	Not yet recruiting
Research Site \| Hershey, Pennsylvania, 17033, United States	Not yet recruiting
Research Site \| Nashville, Tennessee, 37201, United States	Withdrawn
Research Site \| Fort Worth, Texas, 76104, United States	Not yet recruiting
Research Site \| Irving, Texas, 75063, United States	Recruiting
Research Site \| Norfolk, Virginia, 23502, United States	Recruiting
Research Site \| Tacoma, Washington, 98405, United States	Not yet recruiting
Research Site \| Berazategui, B1884BBF, Argentina	Not yet recruiting
Research Site \| Buenos Aires, C1120AAT, Argentina	Not yet recruiting
Research Site \| Caba, C1280AEB, Argentina	Not yet recruiting
Research Site \| Caba, C1426ANZ, Argentina	Not yet recruiting
Research Site \| Ciudad Autónoma Buenos Aires, C1430EFA, Argentina	Not yet recruiting
Research Site \| Ciudad de Buenos Aires, C1419AHL, Argentina	Not yet recruiting
Research Site \| Pergamino, B2700CPM, Argentina	Not yet recruiting
Research Site \| Pilar, B1629AHJ, Argentina	Not yet recruiting
Research Site \| Rosario, S2000KZE, Argentina	Withdrawn
Research Site \| Graz, 8036, Austria	Not yet recruiting
Research Site \| Krems, 3500, Austria	Withdrawn
Research Site \| Linz, 4020, Austria	Not yet recruiting
Research Site \| Salzburg, 5020, Austria	Not yet recruiting
Research Site \| Wiener Neustadt, 2700, Austria	Not yet recruiting
Research Site \| Wien, 1020, Austria	Not yet recruiting
Research Site \| Wien, 1090, Austria	Not yet recruiting
Research Site \| Wien, 1140, Austria	Not yet recruiting
Research Site \| Barretos, 14784-400, Brazil	Not yet recruiting
Research Site \| Curitiba, 81520-060, Brazil	Not yet recruiting
Research Site \| Fortaleza, 60135-237, Brazil	Not yet recruiting
Research Site \| Porto Alegre, 90035-001, Brazil	Not yet recruiting
Research Site \| Porto Alegre, 90035-003, Brazil	Not yet recruiting
Research Site \| Porto Alegre, 90610-000, Brazil	Not yet recruiting
Research Site \| Rio de Janeiro, 22250-905, Brazil	Not yet recruiting
Research Site \| Santa Maria, 97015-450, Brazil	Not yet recruiting
Research Site \| Santo André, 09060-650, Brazil	Not yet recruiting
Research Site \| Sao Paulo, 01246-000, Brazil	Not yet recruiting
Research Site \| Sao Paulo, 01323-903, Brazil	Not yet recruiting
Research Site \| Săo Paulo, 03162-065, Brazil	Not yet recruiting
Research Site \| Uberlândia, 38408-150, Brazil	Not yet recruiting
Research Site \| Hamilton, Ontario, L8V 5C2, Canada	Not yet recruiting
Research Site \| Toronto, Ontario, M4N 3M5, Canada	Not yet recruiting
Research Site \| Toronto, Ontario, M5G 2C1, Canada	Not yet recruiting
Research Site \| Santiago, 7500653, Chile	Not yet recruiting
Research Site \| Santiago, 7500921, Chile	Not yet recruiting
Research Site \| Santiago, 8420383, Chile	Withdrawn
Research Site \| Barranquilla, 80001, Colombia	Not yet recruiting
Research Site \| Cali, 760043, Colombia	Not yet recruiting
Research Site \| Medellin, 050010, Colombia	Not yet recruiting
Research Site \| Medellín, Colombia	Not yet recruiting
Research Site \| Amiens, 80090, France	Not yet recruiting
Research Site \| Bayonne, 64100, France	Not yet recruiting
Research Site \| Bordeaux Cedex, 33075, France	Not yet recruiting
Research Site \| Clermont Ferrand, 63011, France	Not yet recruiting
Research Site \| Lille, 59000, France	Not yet recruiting
Research Site \| Lyon, 69008, France	Not yet recruiting
Research Site \| Marseille CEDEX, 13273, France	Not yet recruiting
Research Site \| Marseille, 13385, France	Not yet recruiting
Research Site \| Montpellier, 34070, France	Not yet recruiting
Research Site \| Nice, 06189, France	Not yet recruiting
Research Site \| Quint-Fonsegrives, 31130, France	Not yet recruiting
Research Site \| Rennes, 35000, France	Not yet recruiting
Research Site \| Strasbourg, 67091, France	Not yet recruiting
Research Site \| Suresnes, 92151, France	Not yet recruiting
Research Site \| Vandoeuvre les Nancy, 54519, France	Not yet recruiting
Research Site \| Bielefeld, 33611, Germany	Not yet recruiting
Research Site \| Bochum, 44791, Germany	Not yet recruiting
Research Site \| Düsseldorf, 40225, Germany	Not yet recruiting
Research Site \| Frankfurt am Main, 60431, Germany	Withdrawn
Research Site \| Giessen, 35392, Germany	Not yet recruiting
Research Site \| Hannover, 30559, Germany	Not yet recruiting
Research Site \| Hannover, 30625, Germany	Not yet recruiting
Research Site \| Köln, 50937, Germany	Not yet recruiting
Research Site \| Magdeburg, 39120, Germany	Not yet recruiting
Research Site \| Mainz, 55131, Germany	Not yet recruiting
Research Site \| Mannheim, 68167, Germany	Not yet recruiting
Research Site \| Muenchen, 81377, Germany	Not yet recruiting
Research Site \| Münster, 48149, Germany	Not yet recruiting
Research Site \| Regensburg, 93053, Germany	Not yet recruiting
Research Site \| Reutlingen, 72766, Germany	Not yet recruiting
Research Site \| Ulm, 89075, Germany	Not yet recruiting
Research Site \| Athens, 11528, Greece	Not yet recruiting
Research Site \| Athens, 12462, Greece	Not yet recruiting
Research Site \| Heraklion, 71110, Greece	Not yet recruiting
Research Site \| Sheffield, S10 2RX, Greece	Not yet recruiting
Research Site \| Shatin, 00000, Hong Kong	Not yet recruiting
Research Site \| Hadera, 38100, Israel	Not yet recruiting
Research Site \| Haifa, 31096, Israel	Not yet recruiting
Research Site \| Holon, 58100, Israel	Not yet recruiting
Research Site \| Jerusalem, 9112001, Israel	Not yet recruiting
Research Site \| Tel Aviv, 64239, Israel	Not yet recruiting
Research Site \| Aviano, 33081, Italy	Not yet recruiting
Research Site \| Bari, 70124, Italy	Not yet recruiting
Research Site \| Firenze, 50134, Italy	Not yet recruiting
Research Site \| Meldola, 47014, Italy	Not yet recruiting
Research Site \| Milano, 20132, Italy	Not yet recruiting
Research Site \| Milan, 20141, Italy	Not yet recruiting
Research Site \| Napoli, 80131, Italy	Not yet recruiting
Research Site \| Padova, 35128, Italy	Not yet recruiting
Research Site \| Pozzuoli, 80078, Italy	Not yet recruiting
Research Site \| Reggio Emilia, 42100, Italy	Not yet recruiting
Research Site \| Roma, 00128, Italy	Not yet recruiting
Research Site \| Roma, 00137, Italy	Not yet recruiting
Research Site \| Roma, 00144, Italy	Not yet recruiting
Research Site \| Terni, 05100, Italy	Not yet recruiting
Research Site \| Tricase (Lecce), 73039, Italy	Not yet recruiting
Research Site \| Verona, 37124, Italy	Not yet recruiting
Research Site \| Bunkyo-ku, 113-8431, Japan	Not yet recruiting
Research Site \| Fukuoka-shi, 811-1395, Japan	Not yet recruiting
Research Site \| Hamamatsu-shi, 431-3192, Japan	Not yet recruiting
Research Site \| Hirosaki-shi, 036-8563, Japan	Not yet recruiting
Research Site \| Ichikawa-shi, 272-8516, Japan	Not yet recruiting
Research Site \| Kanazawa-shi, 920-8641, Japan	Not yet recruiting
Research Site \| Kita-gun, 761-0793, Japan	Not yet recruiting
Research Site \| Kobe-shi, 650-0017, Japan	Not yet recruiting
Research Site \| Kumamoto-shi, 860-0008, Japan	Not yet recruiting
Research Site \| Matsuyama-shi, 791-0288, Japan	Not yet recruiting
Research Site \| Miyazaki-shi, 889-1692, Japan	Not yet recruiting
Research Site \| Okayama-shi, 700-8558, Japan	Not yet recruiting
Research Site \| Osaka-shi, 541-8567, Japan	Not yet recruiting
Research Site \| Osaka-shi, 545-8586, Japan	Not yet recruiting
Research Site \| Osakasayama-shi, 589-8511, Japan	Not yet recruiting
Research Site \| Shinjuku-ku, 160-8582, Japan	Not yet recruiting
Research Site \| Toyama-shi, 930-0194, Japan	Not yet recruiting
Research Site \| Tsukuba-shi, 305-8576, Japan	Not yet recruiting
Research Site \| Yokohama-shi, 241-8515, Japan	Not yet recruiting
Research Site \| Busan, 47392, Korea, Republic of	Not yet recruiting
Research Site \| Goyang-si, 10408, Korea, Republic of	Not yet recruiting
Research Site \| Incheon, 405-760, Korea, Republic of	Not yet recruiting
Research Site \| Seodaemun-gu, 03722, Korea, Republic of	Not yet recruiting
Research Site \| Seongnam-si, 13620, Korea, Republic of	Not yet recruiting
Research Site \| Seoul, 03080, Korea, Republic of	Not yet recruiting
Research Site \| Seoul, 05505, Korea, Republic of	Withdrawn
Research Site \| Seoul, 06351, Korea, Republic of	Not yet recruiting
Research Site \| Colima, 28018, Mexico	Not yet recruiting
Research Site \| Monterrey, 64000, Mexico	Not yet recruiting
Research Site \| Monterrey, 64570, Mexico	Not yet recruiting
Research Site \| Tlalpan, 14050, Mexico	Not yet recruiting
Research Site \| Arnhem, 6815 AD, Netherlands	Not yet recruiting
Research Site \| Breda, 4818 CK, Netherlands	Not yet recruiting
Research Site \| Groningen, 9713 GZ, Netherlands	Not yet recruiting
Research Site \| Hilversum, 1313 XZ, Netherlands	Not yet recruiting
Research Site \| Hoofddorp, 2134 TM, Netherlands	Not yet recruiting
Research Site \| Leiden, 2333 ZA, Netherlands	Not yet recruiting
Research Site \| Nijmegen, 6525 GA, Netherlands	Withdrawn
Research Site \| Utrecht, 3508 GA, Netherlands	Not yet recruiting
Research Site \| Skórzewo, 60-185, Poland	Not yet recruiting
Research Site \| Warszawa, 02-781, Poland	Not yet recruiting
Research Site \| Braga, 4710, Portugal	Not yet recruiting
Research Site \| Faro, 8000-386, Portugal	Not yet recruiting
Research Site \| Lisboa, 1350-352, Portugal	Not yet recruiting
Research Site \| Lisboa, 1500-458, Portugal	Not yet recruiting
Research Site \| Lisboa, 1500-650, Portugal	Not yet recruiting
Research Site \| Lisboa, 1649-035, Portugal	Not yet recruiting
Research Site \| Lisbon, 1169-050, Portugal	Not yet recruiting
Research Site \| Porto, 4200-072, Portugal	Not yet recruiting
Research Site \| Vila Nova de Gaia, 4434-502, Portugal	Not yet recruiting
Research Site \| Ekaterinburg, 620102, Russian Federation	Not yet recruiting
Research Site \| Krasnoyarsk, 644013, Russian Federation	Withdrawn
Research Site \| Nizhniy Novgorod, 603074, Russian Federation	Not yet recruiting
Research Site \| Novosibirsk, 630007, Russian Federation	Not yet recruiting
Research Site \| Saint Petersburg, 193231, Russian Federation	Not yet recruiting
Research Site \| St. Petersburg, 194354, Russian Federation	Not yet recruiting
Research Site \| Ufa, 450054, Russian Federation	Withdrawn
Research Site \| Belgrade, 11000, Serbia	Not yet recruiting
Research Site \| Belgrad, 11000, Serbia	Not yet recruiting
Research Site \| Nis, 18000, Serbia	Not yet recruiting
Research Site \| Sremska Kamenica, 21204, Serbia	Not yet recruiting
Research Site \| Barcelona, 08003, Spain	Withdrawn
Research Site \| Barcelona, 08035, Spain	Not yet recruiting
Research Site \| Barcelona, 08036, Spain	Not yet recruiting
Research Site \| Barcelona, 08041, Spain	Not yet recruiting
Research Site \| Barcelona, 08208, Spain	Not yet recruiting
Research Site \| L'Hospitalet de Llobregat, 08907, Spain	Not yet recruiting
Research Site \| Las Palmas de Gran Canaria, 35016, Spain	Not yet recruiting
Research Site \| Madrid, 28033, Spain	Not yet recruiting
Research Site \| Madrid, 28040, Spain	Not yet recruiting
Research Site \| Madrid, 28046, Spain	Not yet recruiting
Research Site \| Pamplona, 31008, Spain	Not yet recruiting
Research Site \| Santander, 39008, Spain	Not yet recruiting
Research Site \| Sevilla, 41009, Spain	Not yet recruiting
Research Site \| Taichung, 40447, Taiwan	Not yet recruiting
Research Site \| Taichung, 40705, Taiwan	Not yet recruiting
Research Site \| Tainan, 70403, Taiwan	Not yet recruiting
Research Site \| Tainan, 710, Taiwan	Not yet recruiting
Research Site \| Taipei, 10048, Taiwan	Not yet recruiting
Research Site \| Bangkok, 10330, Thailand	Not yet recruiting
Research Site \| Dusit, 10300, Thailand	Not yet recruiting
Research Site \| Songkhla, 90110, Thailand	Not yet recruiting
Research Site \| Adana, 01060, Turkey	Not yet recruiting
Research Site \| Ankara, 06560, Turkey	Not yet recruiting
Research Site \| Ankara, 06620, Turkey	Not yet recruiting
Research Site \| Ankara, 5000, Turkey	Not yet recruiting
Research Site \| Ankara, Turkey	Not yet recruiting
Research Site \| Antalya, Turkey	Not yet recruiting
Research Site \| Istanbul, 32098, Turkey	Not yet recruiting
Research Site \| Istanbul, 34722, Turkey	Not yet recruiting
Research Site \| Karsiyaka, 35575, Turkey	Not yet recruiting
Research Site \| Malatya, 44280, Turkey	Not yet recruiting
Research Site \| Dnipropetrovsk, 49005, Ukraine	Not yet recruiting
Research Site \| Dnipro, 49102, Ukraine	Not yet recruiting
Research Site \| Kharkiv Region, 61000, Ukraine	Withdrawn
Research Site \| Kiev, 3022, Ukraine	Not yet recruiting
Research Site \| Blackburn, BB2 3HH, United Kingdom	Not yet recruiting
Research Site \| Bristol, BS2 8ED, United Kingdom	Not yet recruiting
Research Site \| Gillingham, ME7 5NY, United Kingdom	Not yet recruiting
Research Site \| Glasgow, G12 0XH, United Kingdom	Not yet recruiting
Research Site \| London, EC1A 7BE, United Kingdom	Not yet recruiting
Research Site \| London, NW1 2PG, United Kingdom	Not yet recruiting
Research Site \| Wirral, CH63 4JY, United Kingdom	Withdrawn
Research Site \| Ha Noi, 100000, Vietnam	Not yet recruiting
Research Site \| Hanoi, 100000, Vietnam	Not yet recruiting
Research Site \| Ho Chi Minh City, 123, Vietnam	Not yet recruiting
Research Site \| Ho Chi Minh city, 700000, Vietnam	Not yet recruiting
Research Site \| Hue, 530000, Vietnam	Not yet recruiting

Расположение Страны	Argentina Austria Brazil Canada Chile Colombia France Germany Greece Hong Kong Israel Italy Japan Korea, Republic of Mexico Netherlands Poland Portugal Russian Federation Serbia Spain Taiwan Thailand Turkey Ukraine United Kingdom United States Vietnam
Дата проверки	2021-11-01
Ответственная сторона	Тип: Sponsor
Ключевые слова	Bladder Cancer Immunotherapy PD-L1 Durvalumab (MEDI4736) Tremelimumab Enfortumab Vedotin (PADCEV)
Имеет расширенный доступ	No
Состояние Просмотр	Urinary Bladder Neoplasms
Количество рук	3
Группа вооружений	Метка: Durvalumab + Tremelimumab + Enfortumab vedotin Тип: Experimental Описание: Participants will receive 3 preoperative 21-day cycles of Durvalumab + Tremelimumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 1 cycle of postoperative Tremelimumab and 9 cycles of Durvalumab. Each postoperative cycle is 28 days. Durvalumab 1500 mg by intravenous (IV) infusion given on Day 1 of each cycle. Tremelimumab 75 mg by intravenous (IV) infusion given on Cycle 1 Day 1 and Cycle 2 Day 8 preoperatively and on Cycle 1 Day 1 postoperatively. Enfortumab Vedotin 1.25 mg/kg by intravenous (IV) infusion given on Days 1 and 8 of each 21-day cycle Метка: Durvalumab + Enfortumab vedotin Тип: Experimental Описание: Participants will receive 3 preoperative 21-day cycles of Durvalumab + Enfortumab Vedotin, followed by radical cystectomy, followed by 9 cycles of Durvalumab. Each postoperative cycle is 28 days. Durvalumab 1500 mg by intravenous (IV) infusion given on Day 1 of each cycle. Enfortumab Vedotin 1.25 mg/kg by intravenous (IV) infusion given on Days 1 and 8 of each 21-day cycle. Метка: Straight to cystectomy Тип: Active Comparator Описание: Radical cystectomy alone. Participants receive standard of care surgery alone.
Акроним	VOLGA
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Описание модели вмешательства: Parallel Первичное назначение: Treatment Маскировка: None (Open Label)

Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin