Bladder Cancer Clinical Trial
A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer
Summary
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
Full Description
Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG. The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total duration of the study will be up to 5 years and 2 months. Efficacy, Safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the study.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve
BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)
All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
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 date of randomization
Participants must be willing to undergo all study procedures
Exclusion Criteria:
Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to [>=] T2)
Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded
A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL)
Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
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There are 183 Locations for this study
Little Rock Arkansas, 72211, United States
Los Alamitos California, 90720, United States
Sacramento California, 95630, United States
San Diego California, 92123, United States
Santa Rosa California, 95403, United States
Lakewood Colorado, 80228, United States
Hialeah Florida, 33016, United States
Quincy Illinois, 62301, United States
Carmel Indiana, 46032, United States
Jeffersonville Indiana, 47130, United States
Merriam Kansas, 66204, United States
Wichita Kansas, 67226, United States
Hanover Maryland, 21076, United States
Omaha Nebraska, 68114, United States
New York New York, 10010, United States
Syracuse New York, 13210, United States
Syracuse New York, 13210, United States
Greenville North Carolina, 27834, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37209, United States
Austin Texas, 78745, United States
Houston Texas, 77027, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84148, United States
Virginia Beach Virginia, 23462, United States
Spokane Washington, 99202, United States
Buenos Aires , C1199, Argentina
Buenos Aires , C1417, Argentina
Cordoba , X5000, Argentina
Cordoba , X5016, Argentina
Córdoba , 5000, Argentina
Mar del Plata , B7602, Argentina
Rio Cuarto , 5800, Argentina
Heidelberg , 3084, Australia
Macquarie University , 2109, Australia
Nedlands , 6009, Australia
South Brisbane , 4101, Australia
Antwerpen , 2020, Belgium
Brugge , 8000, Belgium
Brugge , 8310, Belgium
Gent , 9000, Belgium
Gent , 9000, Belgium
Libramont-Chevigny , 6800, Belgium
Roeselare , 8800, Belgium
Sint-Niklaas , 9100, Belgium
Wilrijk , 2610, Belgium
Barretos , 14784, Brazil
Bauru , 17033, Brazil
Campinas , 13083, Brazil
Curitiba , 81520, Brazil
Presidente Prudente , 19013, Brazil
Santa Cruz Do Sul , 96835, Brazil
Sao Paulo , 1321-, Brazil
São Paulo , 01508, Brazil
Halifax Nova Scotia, B3H 2, Canada
Hamilton Ontario, L8N 4, Canada
Toronto Ontario, M5G 1, Canada
Montréal Quebec, H2X 3, Canada
Quebec , G1J1Z, Canada
Beijing , 10003, China
Beijing , 10073, China
Beijing , 10110, China
Chang Sha , 41001, China
Changchun , 13049, China
Chengdu , 61004, China
Chongqing , 40000, China
Deyang City , 61800, China
GuangZhou , 43003, China
Hangzhou , 31000, China
Hangzhou , 31001, China
Nanjing , 21000, China
Ningbo , 31501, China
Shanghai , 20002, China
Shanghai , 20040, China
Shenyang , 11000, China
Tianjin , 30021, China
Wenzhou , 32500, China
Wuhan , 43003, China
Xian , 71006, China
Yantai , 26400, China
Zhengzhou , 45000, China
Brno , 65691, Czechia
Hradec Králové , 500 0, Czechia
Liberec , 460 0, Czechia
Olomouc , 779 0, Czechia
Prague , 15006, Czechia
Praha 4 , 140 5, Czechia
Praha , 100 3, Czechia
Bordeaux , 33000, France
Clermont-Ferrand , 63003, France
Grenoble , 38043, France
Limoges , 87000, France
Lyon , 69437, France
Nantes , 44093, France
Nimes , 30029, France
Orléans , 45067, France
PARIS cedex 20 , 75960, France
Paris , 75015, France
Paris , 75018, France
Quint-Fonsegrives , 31130, France
Rennes , 35000, France
Toulouse , 31059, France
Duisburg , 47169, Germany
Erlangen , 91054, Germany
Essen , 45147, Germany
Frankfurt am Main , 60590, Germany
Freiburg , 79106, Germany
Köln , 50968, Germany
Mettmann , 40822, Germany
Muenster , 48149, Germany
Nuernberg , 90419, Germany
Nurnberg , 90491, Germany
Nürtingen , 72622, Germany
Regensburg , 93053, Germany
Tübingen , 72076, Germany
Bangalore , 56002, India
Gurugram , 12200, India
Kolkata , 70009, India
Pune , 41104, India
Acquaviva delle Fonti , 70021, Italy
Asti , 14100, Italy
Avellino , 83100, Italy
Castelfranco Veneto , 31033, Italy
Milano , 20132, Italy
Milano , 20141, Italy
Napoli , 80138, Italy
Ravenna , 48121, Italy
Rome , 00128, Italy
Fuji-shi , 417-8, Japan
Kanazawa , 920-8, Japan
Kashihara-shi , 634-8, Japan
Kisarazu-shi , 292-8, Japan
Kobe City , 650-0, Japan
Kumamoto-shi , 860-0, Japan
Nagano-shi , 381-8, Japan
Nagasaki-shi , 852-8, Japan
Nagasaki-Shi , 852-8, Japan
Narashino-shi , 275-8, Japan
Toon-shi , 791-0, Japan
Toyama-shi , 930-0, Japan
Ube , 755-8, Japan
Yokohama , 232-0, Japan
Busan , 49241, Korea, Republic of
Cheongju , 28644, Korea, Republic of
Daegu , 41404, Korea, Republic of
Daegu , 42601, Korea, Republic of
Gyeonggi-do , 10408, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Monterrey , 64710, Mexico
Mérida , 97000, Mexico
San Luis Potosí , 78260, Mexico
Nijmegen , 6525 , Netherlands
Bialystok , 15-27, Poland
Bydgoszcz , 85-04, Poland
Lublin , 20-70, Poland
Piotrkow Trybunalski , 97-30, Poland
Poznan , 61-73, Poland
Slupsk , 76-20, Poland
Warszawa , 02-64, Poland
Warszawa , 02-78, Poland
Wroclaw , 50-55, Poland
Vila Nova de Gaia , 4434-, Portugal
A Coruña , 15006, Spain
Algeciras , 11207, Spain
Barcelona , 08025, Spain
Castellon , 12004, Spain
Cádiz , 11009, Spain
L'Hospitalet de Llobregat , 08907, Spain
Lugo , 27003, Spain
Madrid , 28027, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Málaga , 29010, Spain
Santander , 39008, Spain
Valencia , 46010, Spain
Kaohsiung City , 807, Taiwan
Kaohsiung , 833, Taiwan
Taichung City , 404, Taiwan
Taichung , 40705, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 33382, Taiwan
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