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

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 3
    The 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
    88 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

Locations in:
United States, United Kingdom, Spain, South Korea, Poland, Japan, Italy, Israel, Hong Kong, France, Denmark, China, Brazil, Belgium, Austria, Argentina
Country (16) City or Province (88) Status
United States Austin, TX Urology Austin
RECRUITING
United States Bala-Cynwyd, PA MidLantic Urology
RECRUITING
United States Dallas, TX Urology Clinics of North Texas
RECRUITING
United States Detroit, MI Karmanos Cancer Institute
RECRUITING
United States Germantown, TN The Conrad Pearson Clinic
RECRUITING
United States Hanover, MD Chesapeake Urology Research Associates
RECRUITING
United States Houston, TX Houston Metro Urology
RECRUITING
United States Jeffersonville, IN First Urology
RECRUITING
United States Knoxville, TN University of Tennessee Medical Center
RECRUITING
United States Lakewood, CO Colorado Clinical Research
RECRUITING
United States Lancaster, PA Keystone Urology Specialists
RECRUITING
United States Little Rock, AR Arkansas Urology
RECRUITING
United States Los Alamitos, CA Genesis Research LLC
RECRUITING
United States Myrtle Beach, SC Carolina Urologic Research Center
RECRUITING
United States Nashville, TN Urology Associates
RECRUITING
United States New Brunswick, NJ Cancer Institute Of New Jersey
RECRUITING
United States New Orleans, LA Ochsner Health System
RECRUITING
United States New York, NY Integrated Medical Professionals
RECRUITING
United States Omaha, NE The Urology Center, PC
RECRUITING
United States Raleigh, NC Associated Urologists of North Carolina
RECRUITING
United States Royal Oak, MI Comprehensive Urology
RECRUITING
United States Saint Louis, MO Specialty Clinical Research of St Louis
RECRUITING
United States San Diego, CA Genesis Research
RECRUITING
United States Sherman Oaks, CA Genesis Research LLC
RECRUITING
United States Spokane, WA Spokane Urology
RECRUITING
United States Syracuse, NY Associated Medical Professionals of Ny
RECRUITING
United States Wichita, KS Wichita Urology Group
RECRUITING
United Kingdom Bristol Southmead Hospital
RECRUITING
United Kingdom London Charing Cross Hospital
RECRUITING
United Kingdom London St Bartholomews Hospital
RECRUITING
United Kingdom Sutton Royal Marsden Hospital
RECRUITING
Spain Barcelona, BA Hosp Clinic de Barcelona
RECRUITING
Spain Jerez De La Frontera Hosp. de Jerez de La Frontera
RECRUITING
Spain Madrid, MD Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Spain Madrid, MD Hosp. Univ. 12 de Octubre
RECRUITING
Spain Malaga Hosp Virgen de La Victoria
RECRUITING
Spain Sabadell, BA Hosp.Univ.Parc Tauli
RECRUITING
South Korea Chungcheongbuk Do, 43 Chungbuk National University Hospital
RECRUITING
South Korea Gyeonggi-do, 41 National Cancer Center
RECRUITING
South Korea Jeollanam-do, 46 Chonnam National University Hwasun Hospital
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
Poland Bialystok Uniwersytecki Szpital Kliniczny w Bialymstoku
RECRUITING
Poland Bydgoszcz IN VIVO Sp. z o.o
RECRUITING
Poland Przemysl Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
RECRUITING
Poland Tarnow Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
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
Japan Kawasaki Shi, 14 St Marianna University Hospital
RECRUITING
Japan Kumamoto City, 43 National Hospital Organization Kumamoto Medical Center
RECRUITING
Japan Saitama, 11 Saitama Medical Center
RECRUITING
Japan Wakayama, 30 JRC Wakayama Medical Center
RECRUITING
Japan Yokohama, 14 Yokohama City University Medical Center
RECRUITING
Japan Yokohama, 14 Yokohama Municipal Citizens Hospital
RECRUITING
Japan Yokosuka, 14 Yokosuka Kyosai Hospital
RECRUITING
Italy Arezzo Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica
RECRUITING
Italy Brescia ASST Spedali Civili Brescia
RECRUITING
Italy Roma Universita Campus Bio-Medico di Roma
RECRUITING
Italy Torino A.O.Citta della Salute e della Scienza di Torino
RECRUITING
Israel Haifa, H Rambam Health Care Campus
RECRUITING
Israel Jerusalem Hadassah University Hospita Ein Kerem
RECRUITING
Israel Ramat Gan Sheba Medical Center
RECRUITING
Israel Safed Ziv Medical Center
RECRUITING
Israel Tel-Aviv Sourasky Medical Center
RECRUITING
Hong Kong Hong Kong Prince Of Wales Hospital
RECRUITING
Hong Kong Hong Kong Queen Mary Hospital
RECRUITING
France Lyon Hôpital Edouard Herriot
RECRUITING
France Quint-Fonsegrives Clinique de la Croix du Sud
RECRUITING
France Rennes Chu Rennes Hopital Pontchaillou
RECRUITING
Denmark Aarhus Aarhus University Hospital
RECRUITING
Denmark Roskilde Zealand University 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 Nan Jing Shi Zhongda Hospital Southeast University
RECRUITING
China Tianjin, 12 The Second Hospital Of Tianjin Medical University
RECRUITING
China Wenzhou The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Brazil Natal, RN Liga Norte Riograndense Contra O Cancer
RECRUITING
Brazil Sao Paulo, SP Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
Belgium Brugge AZ Sint-Jan
RECRUITING
Belgium Edegem UZ Antwerpen
RECRUITING
Belgium Gent AZ Maria Middelares
RECRUITING
Belgium Sint-Niklaas Vitaz
RECRUITING
Austria Salzburg, SAL Universitaetsklinikum Salzburg Landeskrankenhaus
RECRUITING
Argentina Caba, B Investigaciones Clinico Moleculares (ICM)
RECRUITING
Argentina Ciudad Autonoma de Buenos Aires, B Hospital Sirio Libanes
RECRUITING
Argentina Cordoba Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
RECRUITING
Argentina Córdoba Centro Urologico Profesor Bengio
RECRUITING
Argentina Rosario Sanatorio de la Mujer
RECRUITING
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10

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5

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Corresponds to individual site.

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