A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
MoonRISe-3
A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)
2 other identifiers
interventional
220
15 countries
104
Brief Summary
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2025
Longer than P75 for phase_3
104 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
April 2, 2025
CompletedFirst Posted
Study publicly available on registry
April 9, 2025
CompletedStudy Start
First participant enrolled
September 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 16, 2032
March 13, 2026
March 1, 2026
2.6 years
April 2, 2025
March 12, 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 recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ \[CIS\]), progression, or death due to any cause, whichever occurs first.
Up to 5 years
Secondary Outcomes (13)
Recurrence-Free Survival (RFS)
Up to 5 years
Time to Next Intervention (TTNI)
Up to 5 years
Time to Disease Worsening (TTDW)
Up to 5 years
Time to Progression (TTP)
Up to 5 years
Overall Survival (OS)
Up to 5 years
- +8 more secondary outcomes
Study Arms (2)
Group A: TAR-210
EXPERIMENTALParticipants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will be inserted over a treatment duration of approximately 2 years.
Group B: Mitomycin C (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 maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion.
Interventions
Gemcitabine will be administered intravesically.
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded
- 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
- All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC
- Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \>= 2 toxicity requiring BCG discontinuation (BCG intolerant population)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
- Must be ineligible for or refusing radical cystectomy (RC)
You may not qualify if:
- Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \[i.e.\], T2, T3, T4, N+, and/or M+)
- Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\[N0, M0\] with a Gleason score less than or equal to \[\<=\] 7a, treated locally only \[radical prostatectomy/radiation therapy/focal treatment\]) and other malignancy that is considered at minimal risk of recurrence
- Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210
- A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL)
- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
Georgia Urology
Atlanta, Georgia, 30328, United States
Associated Urological Specialists
Chicago Ridge, Illinois, 60451, United States
Urology of Indiana
Carmel, Indiana, 46032, United States
Greater Boston Urology
Plymouth, Massachusetts, 02360, United States
Comprehensive Urology
Royal Oak, Michigan, 48073, United States
UroHealth Partners
Omaha, Nebraska, 68114, United States
New Jersey Urology LLC
Voorhees Township, New Jersey, 08043, United States
Associated Medical Professionals
Syracuse, New York, 13210, United States
Dayton Physicians Network Urology
Centerville, Ohio, 45459, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Helios Clinical Research, LLC
Middleburg Heights, Ohio, 44130, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
MidLantic Urology
Lancaster, Pennsylvania, 17604, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
The Conrad Pearson Clinic
Germantown, Tennessee, 38138, United States
Urology Austin
Austin, Texas, 78745, United States
Urology San Antonio PA dba USA Clinical Trials
San Antonio, Texas, 78229, United States
Hospital Sirio Libanes
Buenos Aires, C1419AHN, Argentina
Instituto Alexander Fleming
Buenos Aires, C1426ANZ, Argentina
Investigaciones Clinico Moleculares (ICM)
Caba, C1425, Argentina
Centro Urologico Profesor Bengio
Córdoba, X5000KPH, Argentina
Sanatorio de la Mujer
Rosario, 2000, Argentina
Hopital Erasme
Brussels, 1070, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Hospital Regional do Cancer - Hospital de Esperança
Presidente Prudente, 19013-050, Brazil
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
São José do Rio Preto, 15090 000, Brazil
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246 000, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 010, Brazil
Peking University First Hospital
Beijing, 100034, China
The Third People's Hospital of Chengdu
Chengdu, 610014, China
West China Hospital Sichuan University
Chengdu, 610093, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510260, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315020, China
The Second Hospital Of Tianjin Medical University
Tianjin, 300211, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, 430030, China
Institut Paoli Calmettes
Marseille, 13009, France
Hopital Saint Louis
Paris, 75010, France
CHU Pitie Salpetriere
Paris, 75013, France
Hopital Saint Joseph
Paris, 75014, France
Clinique de la Croix du Sud
Quint-Fonsegrives, 31130, France
CHP Saint Gregoire
Saint-Grégoire, 35768, France
Gustave Roussy
Villejuif, 94800, France
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Marien hospital Herne
Herne, 44625, Germany
Klinikum Leverkusen gGmbH
Leverkusen, 51375, Germany
Universitaetsklinikum Mannheim
Mannheim, 68167, Germany
Studienpraxis Urologie Nurtingen
Nürtingen, 72622, Germany
Caritas-Krankenhaus St. Josef
Regensburg, 93053, Germany
General Hospital of Athens G Gennimatas
Athens, 115 27, Greece
Laiko General Hospital of Athens
Athens, 115 27, Greece
Sismanogleio General Hospital
Athens, 15126, Greece
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, 56429, Greece
Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
Thessaloniki, 57001, Greece
Rambam Medical Center
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Cliniche Humanitas Gavazzeni
Bergamo, 24125, Italy
ASST Spedali Civili Brescia
Brescia, 25123, Italy
SPDC Villa Scassi
Genova, 16149, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, 80131, Italy
Istituto Nazionale Tumori Regina Elena
Roma, 00144, Italy
Ospedale S. Maria Della Misericordia
Udine, 33100, Italy
Juntendo University Hospital
Bunkyō City, 113 8431, Japan
Funabashi Municipal Medical Center
Funabashi Shi, 273 8588, Japan
Hakodate Goryoukaku Hospital
Hakodate, 040 8611, Japan
St Marianna University Hospital
Kawasaki, 216 8511, Japan
The Jikei University Hospital
Minatoku, 105 8471, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Yokohama Municipal Citizen's Hospital
Yokohama, 221 0855, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
Canisius-Wilhelmina ZH
Nijmegen, 6532 SZ, Netherlands
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Samsung Medical Center
Gangnam Gu, 06351, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp. Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Puerta Del Mar
Cadiz, 11009, Spain
Hosp. Gral. Univ. de Castellon
Castellon, 12004, Spain
Hosp. Arquitecto Marcide
Ferrol, 15405, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Hosp.Univ.Parc Tauli
Sabadell, 08208, Spain
Hull University Teaching Hospitals NHS Trust
Cottingham, HU16 5JQ, United Kingdom
St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
Southampton University Hospital
Southampton, SO16 6HU, United Kingdom
Lister Hospital
Stevenage, SG1 4AB, United Kingdom
Royal Marsden Hospital
Surrey, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
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
April 2, 2025
First Posted
April 9, 2025
Study Start
September 10, 2025
Primary Completion (Estimated)
April 6, 2028
Study Completion (Estimated)
March 16, 2032
Last Updated
March 13, 2026
Record last verified: 2026-03
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