A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (MoonRISe-1)
Last Updated   August 15, 2024 - 21:00
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
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 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. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced assessment method)
* 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 greater than (>) 4000 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)
DETAILS
LOCATIONS
Country (16) | City or Province (88) | Status |
United States | Austin, TX Urology Austin |
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United States | Bala-Cynwyd, PA MidLantic Urology |
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United States | Dallas, TX Urology Clinics of North Texas |
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United States | Detroit, MI Karmanos Cancer Institute |
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United States | Germantown, TN The Conrad Pearson Clinic |
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United States | Hanover, MD Chesapeake Urology Research Associates |
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United States | Houston, TX Houston Metro Urology |
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United States | Jeffersonville, IN First Urology |
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United States | Knoxville, TN University of Tennessee Medical Center |
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United States | Lakewood, CO Colorado Clinical Research |
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United States | Lancaster, PA Keystone Urology Specialists |
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United States | Little Rock, AR Arkansas Urology |
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United States | Los Alamitos, CA Genesis Research LLC |
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United States | Myrtle Beach, SC Carolina Urologic Research Center |
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United States | Nashville, TN Urology Associates |
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United States | New Brunswick, NJ Cancer Institute Of New Jersey |
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United States | New Orleans, LA Ochsner Health System |
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United States | New York, NY Integrated Medical Professionals |
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United States | Omaha, NE The Urology Center, PC |
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United States | Raleigh, NC Associated Urologists of North Carolina |
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United States | Royal Oak, MI Comprehensive Urology |
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United States | Saint Louis, MO Specialty Clinical Research of St Louis |
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United States | San Diego, CA Genesis Research |
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United States | Sherman Oaks, CA Genesis Research LLC |
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United States | Spokane, WA Spokane Urology |
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United States | Syracuse, NY Associated Medical Professionals of Ny |
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United States | Wichita, KS Wichita Urology Group |
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United Kingdom | Bristol Southmead Hospital |
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United Kingdom | London Charing Cross Hospital |
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United Kingdom | London St Bartholomews Hospital |
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United Kingdom | Sutton Royal Marsden Hospital |
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Spain | Barcelona, BA Hosp Clinic de Barcelona |
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Spain | Jerez De La Frontera Hosp. de Jerez de La Frontera |
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Spain | Madrid, MD Hosp. Gral. Univ. Gregorio Maranon |
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Spain | Madrid, MD Hosp. Univ. 12 de Octubre |
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Spain | Malaga Hosp Virgen de La Victoria |
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Spain | Sabadell, BA Hosp.Univ.Parc Tauli |
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South Korea | Chungcheongbuk Do, 43 Chungbuk National University Hospital |
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South Korea | Gyeonggi-do, 41 National Cancer Center |
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South Korea | Jeollanam-do, 46 Chonnam National University Hwasun Hospital |
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South Korea | Seoul Samsung Medical Center |
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Poland | Bialystok Uniwersytecki Szpital Kliniczny w Bialymstoku |
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Poland | Bydgoszcz IN VIVO Sp. z o.o |
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Poland | Przemysl Wojewodzki Szpital im Sw Ojca Pio w Przemyslu |
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Poland | Tarnow Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie |
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Poland | Torun Medicover Integrated Clinical Services Sp z o o |
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Poland | Wieliszew Mazowiecki Szpital Onkologiczny Sp z o o |
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Poland | Wroclaw 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu |
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Japan | Kawasaki Shi, 14 St Marianna University Hospital |
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Japan | Kumamoto City, 43 National Hospital Organization Kumamoto Medical Center |
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Japan | Saitama, 11 Saitama Medical Center |
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Japan | Wakayama, 30 JRC Wakayama Medical Center |
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Japan | Yokohama, 14 Yokohama City University Medical Center |
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Japan | Yokohama, 14 Yokohama Municipal Citizens Hospital |
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Japan | Yokosuka, 14 Yokosuka Kyosai Hospital |
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Italy | Arezzo Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica |
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Italy | Brescia ASST Spedali Civili Brescia |
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Italy | Roma Universita Campus Bio-Medico di Roma |
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Italy | Torino A.O.Citta della Salute e della Scienza di Torino |
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Israel | Haifa, H Rambam Health Care Campus |
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Israel | Jerusalem Hadassah University Hospita Ein Kerem |
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Israel | Ramat Gan Sheba Medical Center |
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Israel | Safed Ziv Medical Center |
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Israel | Tel-Aviv Sourasky Medical Center |
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Hong Kong | Hong Kong Prince Of Wales Hospital |
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Hong Kong | Hong Kong Queen Mary Hospital |
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France | Lyon Hôpital Edouard Herriot |
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France | Quint-Fonsegrives Clinique de la Croix du Sud |
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France | Rennes Chu Rennes Hopital Pontchaillou |
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Denmark | Aarhus Aarhus University Hospital |
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Denmark | Roskilde Zealand University Hospital |
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China | Cheng Du Shi The Third People's Hospital of Chengdu |
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China | Cheng Du Shi West China School of Medicine/West China Hospital, Sichuan University |
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China | Nan Jing Shi Zhongda Hospital Southeast University |
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China | Tianjin, 12 The Second Hospital Of Tianjin Medical University |
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China | Wenzhou The First Affiliated Hospital of Wenzhou Medical University |
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Brazil | Natal, RN Liga Norte Riograndense Contra O Cancer |
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Brazil | Sao Paulo, SP Fundacao Antonio Prudente A C Camargo Cancer Center |
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Belgium | Brugge AZ Sint-Jan |
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Belgium | Edegem UZ Antwerpen |
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Belgium | Gent AZ Maria Middelares |
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Belgium | Sint-Niklaas Vitaz |
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Austria | Salzburg, SAL Universitaetsklinikum Salzburg Landeskrankenhaus |
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Argentina | Caba, B Investigaciones Clinico Moleculares (ICM) |
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Argentina | Ciudad Autonoma de Buenos Aires, B Hospital Sirio Libanes |
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Argentina | Cordoba Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica |
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Argentina | Córdoba Centro Urologico Profesor Bengio |
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Argentina | Rosario Sanatorio de la Mujer |
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