Bladder Cancer Clinical Trial
Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
Summary
A global phase 3, multicenter, randomized, trial, 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 or who refuse Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer.
The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC).
Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system.
In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.
Full Description
Not provided
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented muscle-invasive UC of the bladder.
Participants with transitional cell and mixed transitional/non-transitional cell histologies;
Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0.
Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC.
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.
Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011) OR Refuse cisplatin based chemotherapy (must be documented in the medical records)
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.
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There are 241 Locations for this study
Phoenix Arizona, 85054, United States
Orange California, 92868, United States
Santa Monica California, 90404, United States
Colorado Springs Colorado, 80909, United States
New Haven Connecticut, 06510, United States
Washington District of Columbia, 20010, United States
Fort Myers Florida, 33901, United States
Coeur d'Alene Idaho, 83814, United States
Maywood Illinois, 60153, United States
Indianapolis Indiana, 46250, United States
Iowa City Iowa, 52242, United States
Scarborough Maine, 04074, United States
Brighton Michigan, 48114, United States
Detroit Michigan, 48202, United States
Jackson Mississippi, 39213, United States
Las Vegas Nevada, 89102, United States
Saddle Brook New Jersey, 07663, United States
Albany New York, 12206, United States
Brooklyn New York, 11219, United States
Buffalo New York, 14263, United States
Syracuse New York, 13210, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43212, United States
Portland Oregon, 97239, United States
Hershey Pennsylvania, 17033, United States
Knoxville Tennessee, 37932, United States
Memphis Tennessee, 38103, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Irving Texas, 75063, United States
Norfolk Virginia, 23502, United States
Spokane Washington, 99208, United States
Tacoma Washington, 98405, United States
Berazategui , B1884, Argentina
Buenos Aires , C1120, Argentina
Buenos Aires , C1431, Argentina
Caba , C1280, Argentina
Caba , C1426, Argentina
Ciudad Autónoma Buenos Aires , C1430, Argentina
Ciudad de Buenos Aires , C1419, Argentina
Pergamino , B2700, Argentina
Pilar , B1629, Argentina
Rosario , S2000, Argentina
Graz , 8036, Austria
Krems , 3500, Austria
Linz , 4020, Austria
Salzburg , 5020, Austria
Wiener Neustadt , 2700, Austria
Wien , 1020, Austria
Wien , 1090, Austria
Wien , 1140, Austria
Barretos , 14784, Brazil
Curitiba , 81520, Brazil
Fortaleza , 60135, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90610, Brazil
Porto Alegre , 91350, Brazil
Rio de Janeiro , 22250, Brazil
Santa Maria , 97015, Brazil
Santo André , 09060, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01323, Brazil
Săo Paulo , 03162, Brazil
Uberlândia , 38408, Brazil
Hamilton Ontario, L8V 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4A 3, Canada
Sherbrooke Quebec, J1H 5, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Quebec , G1R 2, Canada
Santiago , 75006, Chile
Santiago , 75009, Chile
Barranquilla , 80001, Colombia
Cali , 76004, Colombia
Medellin , 05001, Colombia
Medellín , , Colombia
Amiens , 80090, France
Bayonne , 64100, France
Bordeaux Cedex , 33075, France
Clermont Ferrand , 63011, France
Lille , 59000, France
Lyon , 69008, France
Marseille CEDEX , 13273, France
Marseille , 13385, France
Montpellier , 34070, France
Nice , 06189, France
Pierre Benite , 69495, France
Quint-Fonsegrives , 31130, France
Rennes , 35000, France
Saint-Priez En Jarez , 42270, France
Strasbourg , 67091, France
Suresnes , 92150, France
Vandoeuvre les Nancy , 54519, France
Bielefeld , 33611, Germany
Bochum , 44791, Germany
Düsseldorf , 40225, Germany
Giessen , 35392, Germany
Hannover , 30559, Germany
Hannover , 30625, Germany
Herne , 44625, Germany
Köln , 50937, Germany
Magdeburg , 39120, Germany
Mainz , 55131, Germany
Mannheim , 68167, Germany
Muenchen , 81377, Germany
Münster , 48149, Germany
Regensburg , 93053, Germany
Reutlingen , 72766, Germany
Ulm , 89075, Germany
Athens , 11528, Greece
Athens , 12462, Greece
Heraklion , 71110, Greece
Maroussi, Athens , 15125, Greece
Shatin , 00000, Hong Kong
Hadera , 38100, Israel
Haifa , 31096, Israel
Holon , 58100, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Tel Aviv , 64239, Israel
Aviano , 33081, Italy
Bari , 70124, Italy
Firenze , 50134, Italy
Meldola , 47014, Italy
Milano , 20132, Italy
Milan , 20141, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Pozzuoli , 80078, Italy
Reggio Emilia , 42100, Italy
Roma , 00128, Italy
Roma , 00137, Italy
Roma , 00144, Italy
Terni , 05100, Italy
Tricase , 73039, Italy
Verona , 37124, Italy
Bunkyo-ku , 113-8, Japan
Fukuoka-shi , 811-1, Japan
Hamamatsu-shi , 431-3, Japan
Hirosaki-shi , 036-8, Japan
Ichikawa-shi , 272-8, Japan
Kanazawa-shi , 920-8, Japan
Kashihara-shi , 634-8, Japan
Kita-gun , 761-0, Japan
Kobe-shi , 650-0, Japan
Kumamoto-shi , 860-0, Japan
Matsuyama-shi , 791-0, Japan
Miyazaki-shi , 889-1, Japan
Okayama-shi , 700-8, Japan
Osaka-shi , 541-8, Japan
Osaka-shi , 545-8, Japan
Osakasayama-shi , 589-8, Japan
Shinjuku-ku , 160-8, Japan
Toyama-shi , 930-0, Japan
Tsukuba-shi , 305-8, Japan
Yokohama-shi , 241-8, Japan
Busan , 47392, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Incheon , 405-7, Korea, Republic of
Seodaemun-gu , 03722, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 07985, Korea, Republic of
Colima , 28018, Mexico
Monterrey , 64000, Mexico
Monterrey , 64570, Mexico
Tlalpan , 14050, Mexico
Arnhem , 6815 , Netherlands
Breda , 4818 , Netherlands
Groningen , 9713 , Netherlands
Hilversum , 1313 , Netherlands
Hoofddorp , 2134 , Netherlands
Leiden , 2333 , Netherlands
Utrecht , 3508 , Netherlands
Gdańsk , 80-21, Poland
Nowa Sol , 67-10, Poland
Skórzewo , 60-18, Poland
Warszawa , 02-78, Poland
Braga , 4710, Portugal
Coimbra , 3000-, Portugal
Faro , 8000-, Portugal
Lisboa , 1350-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Lisbon , 1169-, Portugal
Porto , 4200-, Portugal
Vila Nova de Gaia , 4434-, Portugal
Ekaterinburg , 62010, Russian Federation
Nizhniy Novgorod , 60307, Russian Federation
Novosibirsk , 63000, Russian Federation
Saint Petersburg , 19323, Russian Federation
St. Petersburg , 19435, Russian Federation
Ufa , 45005, Russian Federation
Belgrade , 11000, Serbia
Belgrad , 11000, Serbia
Nis , 18000, Serbia
Sremska Kamenica , 21204, Serbia
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Barcelona , 08208, Spain
L'Hospitalet de Llobregat , 08907, Spain
Las Palmas de Gran Canaria , 35016, Spain
Madrid , 28033, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Pamplona , 31008, Spain
Santander , 39008, Spain
Sevilla , 41009, Spain
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 70403, Taiwan
Tainan , 710, Taiwan
Taipei , 10048, Taiwan
Bangkok , 10330, Thailand
Dusit , 10300, Thailand
Songkhla , 90110, Thailand
Adana , 01060, Turkey
Ankara , 06560, Turkey
Ankara , 06620, Turkey
Ankara , 5000, Turkey
Ankara , , Turkey
Antalya , , Turkey
Edirne , 22030, Turkey
Istanbul , 32098, Turkey
Istanbul , 34722, Turkey
Karsiyaka , 35575, Turkey
Malatya , 44280, Turkey
Dnipropetrovsk , 49005, Ukraine
Dnipro , 49102, Ukraine
Kiev , 3022, Ukraine
Blackburn , BB2 3, United Kingdom
Bristol , BS2 8, United Kingdom
Gillingham , ME7 5, United Kingdom
Glasgow , G12 0, United Kingdom
London , EC1A , United Kingdom
London , NW1 2, United Kingdom
Sheffield , S10 2, United Kingdom
Ha Noi , 10000, Vietnam
Hanoi , 10000, Vietnam
Ho Chi Minh city , 70000, Vietnam
Ho Chi Minh , 70000, Vietnam
Hue , 53000, Vietnam
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