A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
MoonRISe-1
A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations
1 other identifier
interventional
641
20 countries
193
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2024
Longer than P75 for phase_3
193 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
April 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
April 13, 2026
April 1, 2026
4.2 years
March 13, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Disease Free Survival (DFS)
DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.
From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)
Secondary Outcomes (10)
Time to next Treatment (TTNT)
From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)
High Grade Recurrence-free Survival (HG RFS)
From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)
Progression Free Survival (PFS)
From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)
Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment
From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)
Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)
From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)
- +5 more secondary outcomes
Study Arms (4)
Main Study: Group A: TAR-210
EXPERIMENTALParticipants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
Main Study: Group B: MMC or Gemcitabine
ACTIVE COMPARATORParticipants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
Substudy: Group A: TAR-210
EXPERIMENTALParticipants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.
Substudy: Group B: MMC
ACTIVE COMPARATORParticipants in substudy Group B will receive intravesical MMC once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.
Interventions
TAR-210 will be administered intravesically.
Gemcitabine will be administered intravesically.
MMC will be administered intravesically.
Eligibility Criteria
You may qualify if:
- Main study only: 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)
- Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and \>=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor \>=3 cm
- 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
You may not qualify if:
- 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)
- Substudy:
- \- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (193)
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Genesis Research LLC
Los Alamitos, California, 90720, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Om Research LLC
San Diego, California, 92123, United States
Genesis Research LLC 1
Sherman Oaks, California, 91411, United States
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora, Colorado, 80045, United States
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwestern University
Chicago, Illinois, 60611, United States
First Urology
Jeffersonville, Indiana, 47130, United States
Wichita Urology Group
Wichita, Kansas, 67226, United States
Ochsner Health System
New Orleans, Louisiana, 70121-2429, United States
Chesapeake Urology Research Associates
Hanover, Maryland, 21076, United States
Brigham And Women's Hospital
Boston, Massachusetts, 02115, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Comprehensive Urology
Royal Oak, Michigan, 48073, United States
Mercy Research
St Louis, Missouri, 63141, United States
Specialty Clinical Research of St Louis
St Louis, Missouri, 63141, United States
The Urology Center, PC
Omaha, Nebraska, 68114, United States
Cancer Institute Of New Jersey
New Brunswick, New Jersey, 08901, United States
Integrated Medical Professionals
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Associated Medical Professionals of Ny
Syracuse, New York, 13210, United States
SUNY Upstate Med Univ
Syracuse, New York, 13210, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
The Conrad Pearson Clinic
Germantown, Tennessee, 38138, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Urology Austin
Austin, Texas, 78745, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
UT Southwestern
Dallas, Texas, 75390, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Spokane Urology
Spokane, Washington, 99202, United States
Hospital Sirio Libanes
Buenos Aires, C1419AHN, Argentina
Investigaciones Clinico Moleculares (ICM)
CABA, C1425, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000, Argentina
Centro Urologico Profesor Bengio
Córdoba, X5000KPH, Argentina
Hospital Privado de la Comunidad
Mar del Plata, B7602, Argentina
Sanatorio de la Mujer
Rosario, 2000, Argentina
Medizinische Universitaet Graz
Graz, 8036, Austria
Medizinische Universitat Innsbruck
Innsbruck, 6020, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, 5020, Austria
Medical University Vienna MUV
Vienna, 1090, Austria
AZORG campus Aalst Moorselbaan
Aalst, 9300, Belgium
AZ Sint-Jan
Bruges, 8000, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, 3000, Belgium
Vitaz
Sint-Niklaas, 9100, Belgium
CHU UCL Namur - Site Godinne
Yvoir, 5530, Belgium
Fundacao Pio XII
Barretos, 14780-070, Brazil
Universidade Estadual De Campinas
Campinas, 13083-888, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035-001, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050170, Brazil
HBA SA Assitencia Medica e Hospitalar
Salvador, 41810-011, Brazil
Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870, Brazil
Irmandade Da Santa Casa De Misericordia De Sao Paulo
São Paulo, 01221-020, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-000, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, 01323 900, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Beijing Friendship Hospital Capital Medical University
Beijing, 100050, China
Peking University Third Hospital
Beijing, 100191, China
Hunan Cancer hospital
Changsha, 410013, China
The Third People's Hospital of Chengdu
Cheng Du Shi, 610014, China
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, 610041, China
Chongqing Cancer Hospital
Chongqing, 400033, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
Huadong Hospital Affiliated to Fudan University
Shanghai, 200031, China
The Second Hospital Of Tianjin Medical University
Tianjin, 300061, China
Cancer Hospital of Xinjiang Medical University
Ürümqi, 830011, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430032, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710063, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221004, China
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Fakultni Thomayerova nemocnice
Prague, 140 59, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Aarhus University Hospital
Aarhus, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Zealand University Hospital
Roskilde, 4000, Denmark
Hospital Center University De Lille
Lille, 59000, France
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000, France
Hôpital Edouard Herriot
Lyon, 69003, France
Institut Paoli Calmettes
Marseille, 13009, France
Hopital Saint Louis
Paris, 75010, France
CHU Pitie Salpetriere
Paris, 75013, France
APHP - Hopital Bichat - Claude Bernard
Paris, 75018, France
Clinique de la Croix du Sud
Quint-Fonsegrives, 31130, France
Chu Rennes Hopital Pontchaillou
Rennes, 35000, France
CHU Rangueil
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Charite - Universitaetsmedizin Berlin (CCM)
Berlin, 10117, Germany
Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
Braunschweig, 38126, Germany
Studienzentrum Bayenthal
Cologne, 50968, Germany
Urologische Gemeinschaftspraxis
Dresden, 01307, Germany
Universitaetsklinikum Frankfurt
Frankfurt am Main, 60596, Germany
Urologikum Hamburg MVZ - Germany
Hamburg, 22081, Germany
Marien hospital Herne
Herne, 44625, Germany
Universitatsklinikum Jena
Jena, 07747, Germany
Klinikum rechts der Isar an der Technischen Universitat Munchen
München, 81675, Germany
Klinikum St. Elisabeth Straubing GmbH
Straubing, 94315, Germany
Katharinenhospital Innere Medizin
Stuttgart, 70174, Germany
Prince Of Wales Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Cork University Hospital
Cork, T12 DC4A, Ireland
Mater Misericordiae University Hospital
Dublin, D07 A8NN, Ireland
Mater Private Hospital
Dublin, D07 WKW8, Ireland
Adelaide and Meath Hospital
Dublin, D24 NR0A, Ireland
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah University Hospita Ein Kerem
Jerusalem, 9112001, Israel
Sheba Medical Center
Ramat Gan, 5262000, Israel
Ziv Medical Center
Safed, 13100, Israel
Sourasky Medical Center
Tel Aviv, 6423906, Israel
Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica
Arezzo, 52100, Italy
Cliniche Humanitas Gavazzeni
Bergamo, 24125, Italy
ASST Spedali Civili Brescia
Brescia, 25123, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Istituto Dei Tumori Di Milano
Milan, 20133, Italy
Universita Campus Bio-Medico di Roma
Roma, 00128, Italy
Istituto Nazionale Tumori Regina Elena
Roma, 00144, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
A.O.Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki Shi, 660 8550, Japan
St Marianna University Hospital
Kawasaki Shi, 216 8511, Japan
Kobe City Medical Center General Hospital
Kobe, 650 0047, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860 0008, Japan
Osaka International Cancer Institute
Osaka, 541 8567, Japan
Gunma Prefectural Cancer Center
Ōta-ku, 373 8550, Japan
Saitama Medical Center
Saitama, 350 8550, Japan
JRC Wakayama Medical Center
Wakayama, 640 8558, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, 221 0855, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Yokosuka Kyosai Hospital
Yokosuka, 238 8558, Japan
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15 276, Poland
IN VIVO Sp. z o.o
Bydgoszcz, 85 048, Poland
Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy
Bydgoszcz, 85 796, Poland
Uniwersytecki Szpital Kliniczny nr 4
Lublin, 20 090, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, 37 700, Poland
Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
Tarnów, 33-100, Poland
Medicover Integrated Clinical Services Sp z o o
Torun, 87-100, Poland
Mazowiecki Szpital Onkologiczny Sp z o o
Wieliszew, 05-135, Poland
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Wroclaw, 50 981, Poland
Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii
Wroclaw, 53-413, Poland
Chungbuk National University Hospital
Chungcheongbuk Do, 28644, South Korea
National Cancer Center
Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp. Univ. de La Ribera
Alzira, 46600, Spain
Fund. Puigvert
Barcelona, 08025, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Puerta Del Mar
Cadiz, 11009, Spain
Hosp. Gral. Univ. de Castellon
Castellon, 12004, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Clinica Univ. de Navarra
Madrid, 28027, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Hosp. Univ. Central de Asturias
Oviedo, 33011, Spain
Hosp.Univ.Parc Tauli
Sabadell, 08208, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Adana Baskent Practice and Research Hospital
Adana, 01120, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34153, Turkey (Türkiye)
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Kartal Dr Lutfi Kirdar sehir Hastanesi
Istanbul, 34865, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, 35330, Turkey (Türkiye)
Southmead Hospital
Bristol, BS105NB, United Kingdom
St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SJ, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
Johnson & Johnson Enterprise Innovation Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2024
First Posted
March 20, 2024
Study Start
April 18, 2024
Primary Completion (Estimated)
June 28, 2028
Study Completion (Estimated)
December 31, 2032
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.