Bladder Cancer Clinical Trial
A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
Summary
The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy.
Eligibility Criteria
Inclusion Criteria:
Ineligible for or have elected not to undergo radical cystectomy
All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Thyroid function tests are within the normal range per investigator assessment (or stable on hormone supplementation). Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal test results
Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (>=) 1,500/cubic millimeters (mm^3); Platelet count >=80,000/mm^3; Hemoglobin >=9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (<=) 1.5 * upper limit of normal (ULN) or direct bilirubin <= ULN for participants with total bilirubin levels greater than (>)1.5*ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (<=) 2.5* institutional ULN); Renal function: Creatinine clearance >=30 mL/min using the Cockcroft-Gault formula. 24-hour creatinine clearance test will also be accepted for estimating renal function in situations where Cockcroft-Gault formula is not a good predictor of estimating adequate renal function
Exclusion Criteria:
Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study
Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT
Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to randomization
Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 200
Evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has healed prior to randomization
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There are 242 Locations for this study
Los Angeles California, 90033, United States
Santa Monica California, 90404, United States
Stanford California, 94305, United States
Denver Colorado, 80211, United States
Golden Colorado, 80401, United States
Hialeah Florida, 33016, United States
Atlanta Georgia, 30322, United States
Lisle Illinois, 60532, United States
Ann Arbor Michigan, 48109, United States
Omaha Nebraska, 68114, United States
Voorhees New Jersey, 08043, United States
Bronx New York, 10461, United States
Durham North Carolina, 27710, United States
Greenville North Carolina, 27834, United States
Winston-Salem North Carolina, 27103, United States
Oklahoma City Oklahoma, 73104, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Myrtle Beach South Carolina, 29572, United States
Knoxville Tennessee, 37920, United States
League City Texas, 77573, United States
Norfolk Virginia, 23502, United States
Bariloche , 8400, Argentina
Buenos Aires , C1419, Argentina
Buenos Aires , C1426, Argentina
Ciudad Autónoma De Buenos Aires , C1199, Argentina
Córdoba , 5000, Argentina
Córdoba , X5000, Argentina
Pergamino , B2700, Argentina
Viedma , R8500, Argentina
Bedford Park , 5042, Australia
Linz , 4010, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Anderlecht , 1070, Belgium
Antwerpen , 2020, Belgium
Assebroek , 8310, Belgium
Brugge , 8000, Belgium
Kortrijk , 8500, Belgium
Barretos , 14784, Brazil
Belo Horizonte , 31110, Brazil
Curitiba , 81520, Brazil
Fortaleza , 60336, Brazil
Jardim Blumenau , 89010, Brazil
Jau , 17210, Brazil
Natal , 59062, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90610, Brazil
Presidente Prudente , 19013, Brazil
Salvador , 41253, Brazil
Santo André , 09060, Brazil
Sao Jose do Rio Preto , 15090, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 04039, Brazil
Sao Paulo , 04784, Brazil
Uberlândia , 38408, Brazil
Beijing , 10002, China
Beijing , 10003, China
Beijing , 10019, China
Beijing , 10073, China
Changchun , 13002, China
Changsha Shi , 41001, China
Changsha , 41001, China
Chengdu , 61004, China
Chongqing , 40003, China
Guang Zhou Shi , 51018, China
Guangzhou , 51006, China
Hangzhou , 31001, China
Jiaxing , 11026, China
Nanjing , 21000, China
Qingdao , 26601, China
Shanghai , 20000, China
Shanghai , 20002, China
Shenyang , 11000, China
Tianjin , 30004, China
Wenzhou Shi , 32500, China
Wuhan , 43002, China
Wuhan , 43003, China
Yantai , 26400, China
Zhengzhou , 45000, China
Opava , 746 0, Czechia
Plzen-Bory , 305 9, Czechia
Praha 2 , 120 0, Czechia
Praha 4 , 140 5, Czechia
Praha 5 , 150 0, Czechia
Praha 8 , 180 8, Czechia
Praha , 100 3, Czechia
Hyeres , 83400, France
Limoges , 87000, France
Lyon Cedex 03 , 69437, France
Marseille , 13009, France
Marseille , 13698, France
Montpellier , 34298, France
Nimes , 30029, France
Paris , 75015, France
Paris , 75018, France
Saint-Grégoire , 35760, France
Suresnes , 92150, France
Duisburg , 47179, Germany
Düesseldorf , 40225, Germany
Frankfurt Am Main , 60431, Germany
Frankfurt am Main , 60590, Germany
Herne , 44625, Germany
Markkleeberg , 04416, Germany
Münster , 48149, Germany
Nürnberg , 90419, Germany
Athens , 11528, Greece
Holargos , 155 6, Greece
Maroussi , 151 2, Greece
Neo Faliro , 18547, Greece
Thessaloniki , 546 2, Greece
Thessaloniki , 54645, Greece
Thessaloniki , TK 56, Greece
Volos , 38333, Greece
Budapest N/a , 1122, Hungary
Budapest , 1062, Hungary
Budapest , 1106, Hungary
Debrecen , 4032, Hungary
NyÃregyháza , 4400, Hungary
Amravati , 40060, India
Bikaner , 334 0, India
Nashik , 42200, India
New Delhi , 11000, India
New Delhi , 11007, India
New Delhi , 11008, India
Patna , 80001, India
Pune , 41100, India
Candiolo , 10060, Italy
Foggia , 71100, Italy
Genova , 16100, Italy
Genova , 16132, Italy
Milano , 20141, Italy
Milan , 20132, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Pagani , 84016, Italy
Pisa , 56126, Italy
Pozzuoli , 80078, Italy
Roma , 00168, Italy
Roma , 00189, Italy
Rome , 00128, Italy
Rome , 00144, Italy
Torino , 10126, Italy
Varese , 21100, Italy
Vicenza , 36100, Italy
Iizuka , 820-8, Japan
Kanagawa , 216-8, Japan
Kashihara , 634-8, Japan
Kawagoe-Shi , 350-8, Japan
Kisarazu-shi , 292-8, Japan
Nagasaki-shi , 852-8, Japan
Osaka , 591-8, Japan
Shunan , 745-8, Japan
Tokyo , 105-8, Japan
Toyoake , 470-1, Japan
Ube , 755-8, Japan
Yokohama , 232-0, Japan
Busan , 612-8, Korea, Republic of
Daegu , 41404, Korea, Republic of
Daegu , 42601, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Namdong , 405 7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06591, Korea, Republic of
Yangsan-si , 50612, Korea, Republic of
Ciudad de México , 06720, Mexico
Guadalajara , 45050, Mexico
Juchitan De Zaragoza , 70000, Mexico
Leon , 37000, Mexico
Monterrey , 64710, Mexico
Morelia , 58260, Mexico
San Luis Potosi , 78250, Mexico
Zapopan , 45070, Mexico
Siedlce , 08-11, Poland
Skorzewo , 60-18, Poland
Warszawa , 02-50, Poland
Wroclaw , 50556, Poland
Coimbra , 30000, Portugal
Lisboa , 1649-, Portugal
Lisbon , 1400-, Portugal
Porto , 4200-, Portugal
Barnaul , 65604, Russian Federation
Ivanovo , 15304, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Moscow , 12528, Russian Federation
Obninsk , 24903, Russian Federation
Omsk , 64401, Russian Federation
Ryazan , 39001, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saransk , 43000, Russian Federation
Sochi , 35405, Russian Federation
Tyumen , 62504, Russian Federation
Ufa , 45000, Russian Federation
A Coruña , 15006, Spain
Granada , 18014, Spain
Jerez de la Frontera , 11407, Spain
Madrid , 28027, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Sabadell , 08208, Spain
Valencia , 46010, Spain
Kaohsiung , 807, Taiwan
Taichung , 40447, Taiwan
Taichung , 407, Taiwan
Tainan , 70403, Taiwan
Taipei , 10048, Taiwan
Taipei , 11490, Taiwan
Taoyuan , 333, Taiwan
Ankara , 06050, Turkey
Balcova , 35330, Turkey
Gaziantep , 27584, Turkey
Istanbul , 34732, Turkey
Izmir , 35530, Turkey
Malatya , 44280, Turkey
Melikgazi , 38039, Turkey
Seyhan , 01330, Turkey
Chernihiv , 14029, Ukraine
Dnipro , 49005, Ukraine
Kharkiv , 61070, Ukraine
Kherson , 73000, Ukraine
Kiev , 08173, Ukraine
Kyiv , 02660, Ukraine
Kyiv , 04053, Ukraine
Kyiv , 04112, Ukraine
Lviv , 79000, Ukraine
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