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My Saved Trials

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (MoonRISe-1)

Last Updated   May 14, 2025

Want to learn how to participate in this trial?

42756493BLC3004

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 3
    3
  • Sites
    190 Sites
  • Status
    Recruiting

SUMMARY

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

CONDITIONS

  • Non-Muscle Invasive Bladder Cancer

ELIGIBILITY


Inclusion Criteria:

* Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor >= 3 cm, iii. Early recurrence (less than [<] 1 year), iv. Frequent recurrence (greater than [>] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
* Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
* Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.
* Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
* Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
* Have an Eastern Cooperative Oncology Group performance status of 0 to 2


Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs
* Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
* Polyuria with recorded 24-hour urine volumes > 4000 milliliters (mL)
* Current indwelling urinary catheters, however, intermittent catheterization is acceptable
* Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)


Inclusion Criteria:

* Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equ

More...

DETAILS

LOCATIONS

Locations in:
United States, Argentina, Hong Kong, Israel, Japan, South Korea, Poland, Spain, United Kingdom, Austria, Belgium, Brazil, China, Czechia, Denmark, France, Germany, Ireland, Italy, Türkiye
Country (20) City or Province (190) Status
United States Little Rock Arkansas Urology
RECRUITING
United States Los Alamitos Genesis Research LLC
RECRUITING
United States San Diego Genesis Research
RECRUITING
United States Sherman Oaks Genesis Research LLC
RECRUITING
United States Lakewood Colorado Clinical Research
RECRUITING
United States Jeffersonville First Urology
RECRUITING
United States Royal Oak Comprehensive Urology
RECRUITING
United States Saint Louis Specialty Clinical Research of St Louis
RECRUITING
United States New Brunswick Cancer Institute Of New Jersey
RECRUITING
United States New York Integrated Medical Professionals
RECRUITING
United States Syracuse Associated Medical Professionals of Ny
RECRUITING
United States Raleigh Associated Urologists of North Carolina
RECRUITING
United States Bala-Cynwyd MidLantic Urology
RECRUITING
United States Lancaster Keystone Urology Specialists
RECRUITING
United States Myrtle Beach Carolina Urologic Research Center
RECRUITING
United States Germantown The Conrad Pearson Clinic
RECRUITING
United States Nashville Urology Associates
RECRUITING
United States Austin Urology Austin
RECRUITING
United States Dallas Urology Clinics of North Texas
RECRUITING
United States Houston Houston Metro Urology
RECRUITING
United States Spokane Spokane Urology
RECRUITING
Argentina Caba Investigaciones Clinico Moleculares (ICM)
RECRUITING
Argentina Ciudad Autonoma de Buenos Aires Hospital Sirio Libanes
RECRUITING
Hong Kong Hong Kong Prince Of Wales Hospital
RECRUITING
Hong Kong Hong Kong Queen Mary Hospital
RECRUITING
Israel Haifa Rambam Health Care Campus
RECRUITING
Israel Jerusalem Hadassah University Hospita Ein Kerem
RECRUITING
Israel Safed Ziv Medical Center
RECRUITING
Israel Tel-Aviv Sourasky Medical Center
RECRUITING
Japan Kawasaki Shi St Marianna University Hospital
RECRUITING
Japan Wakayama JRC Wakayama Medical Center
RECRUITING
Japan Yokohama Yokohama City University Medical Center
RECRUITING
Japan Yokosuka Yokosuka Kyosai Hospital
RECRUITING
South Korea Jeollanam-do Chonnam National University Hwasun Hospital
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
Poland Tarnow Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
RECRUITING
Spain Madrid Hosp. Univ. 12 de Octubre
RECRUITING
United Kingdom London St Bartholomews Hospital
RECRUITING
United Kingdom London Charing Cross Hospital
RECRUITING
United Kingdom Sutton Royal Marsden Hospital
RECRUITING
United States Los Angeles USC Norris Comprehensive Cancer Center
RECRUITING
United States Orange University of California Irvine Medical Center
RECRUITING
United States Aurora University of Colorado Cancer Center Anschultz Cancer Pavilion
RECRUITING
United States Tampa Moffitt Cancer Center
RECRUITING
United States Chicago Northwestern University
RECRUITING
United States Wichita Wichita Urology Group
RECRUITING
United States New Orleans Ochsner Health System
RECRUITING
United States Detroit Karmanos Cancer Institute
RECRUITING
United States Saint Louis Mercy Research
RECRUITING
United States Omaha The Urology Center, PC
RECRUITING
United States Syracuse SUNY Upstate Med Univ
RECRUITING
United States Charlotte Levine Cancer Institute
RECRUITING
United States Knoxville University of Tennessee Medical Center
RECRUITING
Argentina Cordoba Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
RECRUITING
Argentina Mar del Plata Hospital Privado de la Comunidad
RECRUITING
Argentina Rosario Sanatorio de la Mujer
RECRUITING
Austria Graz Medizinische Universitaet Graz
RECRUITING
Austria Linz Ordensklinikum Linz GmbH Elisabethinen
RECRUITING
Austria Salzburg Universitaetsklinikum Salzburg Landeskrankenhaus
RECRUITING
Austria Wien Medical University Vienna MUV
RECRUITING
Belgium Aalst Onze -Lieve-Vrouwziekenhuis
RECRUITING
Belgium Brugge AZ Sint-Jan
RECRUITING
Belgium Edegem UZ Antwerpen
RECRUITING
Belgium Gent AZ Maria Middelares
RECRUITING
Belgium Leuven Universitair Ziekenhuis Gasthuisberg
RECRUITING
Belgium Sint Niklaas Vitaz
RECRUITING
Belgium Yvoir CHU UCL Namur - Site Godinne
RECRUITING
Brazil Barretos Fundacao Pio XII
RECRUITING
Brazil Campinas Universidade Estadual De Campinas
RECRUITING
Brazil Natal Liga Norte Riograndense Contra O Cancer
RECRUITING
Brazil Porto Alegre Associacao Hospitalar Moinhos de Vento
RECRUITING
Brazil Porto Alegre Irmandade da Santa Casa de Misericordia de Porto Alegre
RECRUITING
Brazil Salvador HBA SA Assitencia Medica e Hospitalar
RECRUITING
Brazil Santo Andre Fundacao do ABC Centro Universitario FMABC
RECRUITING
Brazil Sao Paulo Irmandade Da Santa Casa De Misericordia De Sao Paulo
RECRUITING
Brazil Sao Paulo Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
RECRUITING
Brazil Sao Paulo Real e Benemérita Associação Portuguesa de Beneficência
RECRUITING
Brazil Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
China Beijing Beijing Friendship Hospital Capital Medical University
RECRUITING
China Beijing Peking University Third Hospital
RECRUITING
China Changsha Hunan Cancer hospital
RECRUITING
China Cheng Du Shi The Third People's Hospital of Chengdu
RECRUITING
China Cheng Du Shi West China School of Medicine/West China Hospital, Sichuan University
RECRUITING
China Chong Qing Chongqing Cancer Hospital
RECRUITING
China Fu Zhou Shi Fujian Medical University Union Hospital
RECRUITING
China Nan Jing Shi Nanjing Drum Tower Hospital
RECRUITING
China Nan Jing Shi Zhongda Hospital Southeast University
RECRUITING
China Shanghai Huadong Hospital Affiliated to Fudan University
RECRUITING
China Tianjin The Second Hospital Of Tianjin Medical University
RECRUITING
China Urumqi Cancer Hospital of Xinjiang Medical University
RECRUITING
China Wenzhou The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
China Wu Han Shi Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
China XI An Shi The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
China Xuzhou The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Czechia Hradec Kralove Fakultni nemocnice Hradec Kralove
RECRUITING
Czechia Olomouc Fakultni nemocnice Olomouc
RECRUITING
Czechia Praha 2 Vseobecna fakultni nemocnice v Praze
RECRUITING
Czechia Praha 4 Fakultni Thomayerova nemocnice
RECRUITING
Czechia Praha Fakultni nemocnice v Motole
RECRUITING
Denmark Aarhus Aarhus University Hospital
RECRUITING
Denmark Herlev Herlev Hospital
RECRUITING
Denmark Kobenhavn Rigshospitalet
RECRUITING
Denmark Odense Odense Universitetshospital
RECRUITING
Denmark Roskilde Zealand University Hospital
RECRUITING
France Lille Hospital Center University De Lille
RECRUITING
France Limoges Polyclinique de Limoges - Francois Chenieux
RECRUITING
France Lyon Hôpital Edouard Herriot
RECRUITING
France Marseille Institut Paoli Calmettes
RECRUITING
France Paris Hopital Saint Louis
RECRUITING
France Paris CHU Pitie Salpetriere
RECRUITING
France Paris APHP - Hopital Bichat - Claude Bernard
RECRUITING
France Quint-Fonsegrives Clinique de la Croix du Sud
RECRUITING
France Rennes Chu Rennes Hopital Pontchaillou
RECRUITING
France Toulouse CHU Rangueil
RECRUITING
France Villejuif Institut Gustave Roussy
RECRUITING
Germany Berlin Charite - Universitaetsmedizin Berlin (CCM)
RECRUITING
Germany Braunschweig Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
RECRUITING
Germany Dresden Urologische Gemeinschaftspraxis
RECRUITING
Germany Frankfurt am Main Universitaetsklinikum Frankfurt
RECRUITING
Germany Hamburg Urologikum Hamburg MVZ - Germany
RECRUITING
Germany Herne Marien hospital Herne
RECRUITING
Germany Jena Universitatsklinikum Jena
RECRUITING
Germany Koeln Studienzentrum Bayenthal
RECRUITING
Germany Munchen Klinikum rechts der Isar an der Technischen Universitat Munchen
RECRUITING
Germany Straubing Klinikum St. Elisabeth Straubing GmbH
RECRUITING
Germany Stuttgart Katharinenhospital Innere Medizin
RECRUITING
Ireland Cork Cork University Hospital
RECRUITING
Ireland Dublin Mater Misericordiae University Hospital
RECRUITING
Ireland Dublin Mater Private Hospital
RECRUITING
Ireland Dublin Adelaide and Meath Hospital
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Italy Arezzo Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica
RECRUITING
Italy Bergamo Cliniche Humanitas Gavazzeni
RECRUITING
Italy Brescia ASST Spedali Civili Brescia
RECRUITING
Italy Milano Ospedale San Raffaele
RECRUITING
Italy Milano Istituto Dei Tumori Di Milano
RECRUITING
Italy Roma Universita Campus Bio-Medico di Roma
RECRUITING
Italy Roma Istituto Nazionale Tumori Regina Elena
RECRUITING
Italy Rozzano Istituto Clinico Humanitas
RECRUITING
Italy Torino A.O.Citta della Salute e della Scienza di Torino
RECRUITING
Japan Amagasaki shi Hyogo Prefectural Amagasaki General Medical Center
RECRUITING
Japan Kobe City Kobe City Medical Center General Hospital
RECRUITING
Japan Kumamoto City National Hospital Organization Kumamoto Medical Center
RECRUITING
Japan Osaka Osaka International Cancer Institute
RECRUITING
Japan Ota Gunma Prefectural Cancer Center
RECRUITING
Japan Saitama Saitama Medical Center
RECRUITING
Japan Yokohama Yokohama Municipal Citizen's Hospital
RECRUITING
South Korea Chungcheongbuk Do Chungbuk National University Hospital
RECRUITING
South Korea Gyeonggi-do National Cancer Center
RECRUITING
South Korea Seoul The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
South Korea Seoul Seoul National University Hospital
RECRUITING
Poland Bialystok Uniwersytecki Szpital Kliniczny w Bialymstoku
RECRUITING
Poland Bydgoszcz IN VIVO Sp. z o.o
RECRUITING
Poland Bydgoszcz Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
RECRUITING
Poland Lublin Uniwersytecki Szpital Kliniczny nr 4
RECRUITING
Poland Przemysl Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
RECRUITING
Poland Torun Medicover Integrated Clinical Services Sp z o o
RECRUITING
Poland Wieliszew Mazowiecki Szpital Onkologiczny Sp z o o
RECRUITING
Poland Wroclaw 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
RECRUITING
Poland Wroclaw Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii
RECRUITING
Spain A Coruna Hosp Univ A Coruna
RECRUITING
Spain Alzira Hosp. Univ. de La Ribera
RECRUITING
Spain Barcelona Fund. Puigvert
RECRUITING
Spain Barcelona Hosp Univ Vall D Hebron
RECRUITING
Spain Barcelona Hosp Clinic de Barcelona
RECRUITING
Spain Cadiz Hosp. Puerta Del Mar
RECRUITING
Spain Castellon Hosp. Gral. Univ. de Castellon
RECRUITING
Spain Jerez De La Frontera Hosp. de Jerez de La Frontera
RECRUITING
Spain Madrid Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Spain Madrid Clinica Univ. de Navarra
RECRUITING
Spain Malaga Hosp Virgen de La Victoria
RECRUITING
Spain Oviedo Hosp. Univ. Central de Asturias
RECRUITING
Spain Sabadell Hosp.Univ.Parc Tauli
RECRUITING
Spain Sevilla Hosp. Virgen Del Rocio
RECRUITING
Spain Valencia Hosp. Clinico Univ. de Valencia
RECRUITING
Türkiye Adana Adana Baskent Practice and Research Hospital
RECRUITING
Türkiye Ankara Ankara University Medical Faculty
RECRUITING
Türkiye Ankara Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
Türkiye Istanbul Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Türkiye Istanbul T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
RECRUITING
Türkiye Istanbul Kartal Dr Lutfi Kirdar sehir Hastanesi
RECRUITING
Türkiye Izmir Dokuz Eylul University Medical Faculty
RECRUITING
United Kingdom Bristol Southmead Hospital
RECRUITING
United Kingdom Newcastle Upon Tyne Newcastle Freeman Hospital
RECRUITING
United Kingdom Sheffield Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
United Kingdom Southampton Southampton General Hospital
RECRUITING
United States Hanover Chesapeake Urology Research Associates
COMPLETED
Argentina Cordoba Centro Urologico Profesor Bengio
RECRUITING
Austria Innsbruck Medizinische Universitat Innsbruck
RECRUITING
China Guang Zhou Shi Sun Yat Sen University Cancer Center
RECRUITING
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Geo Locations

34.74648, -92.28959

33.80307, -118.07256

32.71533, -117.15726

34.15112, -118.44925

39.70471, -105.08137

38.27757, -85.73718

42.48948, -83.14465

38.62727, -90.19789

40.48622, -74.45182

40.71427, -74.00597

43.04812, -76.14742

35.7721, -78.63861

40.00761, -75.23407

40.03788, -76.30551

33.68906, -78.88669

35.08676, -89.81009

36.16589, -86.78444

30.26715, -97.74306

32.78306, -96.80667

29.76328, -95.36327

47.65966, -117.42908

-34.61315, -58.37723

-34.61315, -58.37723

22.27832, 114.17469

22.27832, 114.17469

32.81841, 34.9885

31.76904, 35.21633

32.96465, 35.496

32.08088, 34.78057

35.52056, 139.71722

34.23333, 135.16667

35.43333, 139.65

35.28361, 139.66722

35.056264, 127.0025403

37.566, 126.9784

50.01381, 20.98698

40.4165, -3.70256

51.50853, -0.12574

51.50853, -0.12574

51.35, -0.2

34.05223, -118.24368

33.78779, -117.85311

39.72943, -104.83192

27.94752, -82.45843

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29.95465, -90.07507

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38.62727, -90.19789

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43.04812, -76.14742

35.22709, -80.84313

35.96064, -83.92074

-31.4135, -64.18105

-38.00228, -57.55754

-32.94682, -60.63932

47.06667, 15.45

48.30639, 14.28611

47.79941, 13.04399

48.20849, 16.37208

50.93604, 4.0355

51.20892, 3.22424

51.15662, 4.44504

51.05, 3.71667

50.87959, 4.70093

51.16509, 4.1437

50.3279, 4.88059

-20.55722, -48.56778

-22.90556, -47.06083

-5.795, -35.20944

-30.03306, -51.23

-30.03306, -51.23

-12.97111, -38.51083

-23.66389, -46.53833

-23.5475, -46.63611

-23.5475, -46.63611

-23.5475, -46.63611

-23.5475, -46.63611

39.9075, 116.39723

39.9075, 116.39723

28.19874, 112.97087

30.6715699, 104.06623

30.5970699, 104.05106

29.6433899, 106.45187

26.0855999, 119.307

32.0504399, 118.77799

32.0722999, 118.7799999

31.22222, 121.45806

39.14222, 117.17667

43.80096, 87.60046

27.99942, 120.66682

30.5898799, 114.25096

34.2075699, 108.94631

34.18045, 117.15707

50.20923, 15.83277

49.59552, 17.25175

50.08804, 14.42076

50.08804, 14.42076

50.08804, 14.42076

56.15674, 10.21076

55.72366, 12.43998

55.67594, 12.56553

55.39594, 10.38831

55.64152, 12.08035

50.63297, 3.05858

45.83153, 1.25781

45.74848, 4.84669

43.29551, 5.38958

48.85341, 2.3488

48.85341, 2.3488

48.85341, 2.3488

43.5852, 1.5272

48.11198, -1.67429

43.60426, 1.44367

48.7939, 2.35992

52.52437, 13.41053

52.26594, 10.52673

51.05089, 13.73832

50.11552, 8.68417

53.57532, 10.01534

51.5388, 7.22572

50.92878, 11.5899

50.93333, 6.95

48.13743, 11.57549

48.88126, 12.57385

48.78232, 9.17702

51.89797, -8.47061

53.33306, -6.24889

53.33306, -6.24889

53.33306, -6.24889

32.08227, 34.81065

43.46276, 11.88068

45.69601, 9.66721

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41.89193, 12.51133

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45.38193, 9.1559

45.07049, 7.68682

34.71667, 135.41667

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36.3, 139.36667

35.90807, 139.65657

35.43333, 139.65

36.6266068, 127.4570629

37.58944, 126.76917

37.566, 126.9784

37.566, 126.9784

53.13333, 23.16433

53.1235, 18.00762

53.1235, 18.00762

51.25, 22.56667

49.78498, 22.76728

53.01375, 18.59814

52.4513, 20.96827

51.1, 17.03333

51.1, 17.03333

43.37135, -8.396

39.15, -0.43333

41.38879, 2.15899

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36.52672, -6.2891

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40.4165, -3.70256

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39.19289, -76.72414

-31.4135, -64.18105

47.26266, 11.39454

23.1323999, 113.288

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