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Non-Muscle Invasive Bladder NeoplasmsPhase 3MoonRISe-3NCT06919965

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

A Phase 3 study testing TAR-210, Mitomycin C and Gemcitabine in people with Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC at 114 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Muscle Invasive Bladder Neoplasms
What is being tested?
TAR-210, Mitomycin C and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
114 sitesin 15 countries
Study dates
10 Sep 2025to 16 Mar 2032
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

114 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

114 sites in 15 countries

United States27 sites, 24 recruiting

  • Georgia Urology

    Atlanta, Georgia, 30328

    Recruiting

  • Texas Oncology-Austin

    Austin, Texas, 78731

    Recruiting

  • Urology Austin

    Austin, Texas, 78745

    Recruiting

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

    Recruiting

  • Urology of Indiana

    Carmel, Indiana, 46032

    Recruiting

  • Dayton Physicians Network Urology

    Centerville, Ohio, 45459

    Recruiting

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415

    Recruiting

  • The Urology Group

    Cincinnati, Ohio, 45212

    Completed

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

    Recruiting

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138

    Recruiting

  • UroPartners

    Glenview, Illinois, 60026

    Recruiting

  • Southern Urology LLC

    Lafayette, Louisiana, 70508

    Recruiting

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

    Recruiting

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

    Recruiting

  • Advanced Urology Institute

    Largo, Florida, 33771

    Recruiting

  • UCLA

    Los Angeles, California, 90095

    Recruiting

  • Helios Clinical Research, LLC

    Middleburg Heights, Ohio, 44130

    Completed

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • UroHealth Partners

    Omaha, Nebraska, 68114

    Completed

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Greater Boston Urology

    Plymouth, Massachusetts, 02360

    Recruiting

  • Comprehensive Urology

    Royal Oak, Michigan, 48073

    Recruiting

  • Urology San Antonio PA dba USA Clinical Trials

    San Antonio, Texas, 78229

    Recruiting

  • Oregon Urology Institute

    Springfield, Oregon, 97477

    Recruiting

  • Academic Urology and Urogynecology of Arizona

    Sun City, Arizona, 85351

    Recruiting

  • Associated Medical Professionals

    Syracuse, New York, 13210

    Recruiting

  • New Jersey Urology LLC

    Voorhees Township, New Jersey, 08043

    Recruiting

Other trials in United States

China9 sites, 9 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • The Third People's Hospital of Chengdu

    Chengdu, 610014

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, 610093

    Recruiting

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, 510260

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

    Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315020

    Recruiting

  • The Second Hospital Of Tianjin Medical University

    Tianjin, 300211

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

    Wuhan, 430030

    Recruiting

Other trials in China

Spain9 sites, 9 recruiting

  • Hosp Univ A Coruna

    A Coruña, 15006

    Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hosp. Puerta Del Mar

    Cadiz, 11009

    Recruiting

  • Hosp. Gral. Univ. de Castellon

    Castellon, 12004

    Recruiting

  • Hosp. Arquitecto Marcide

    Ferrol, 15405

    Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp Virgen de La Victoria

    Málaga, 29010

    Recruiting

  • Hosp.Univ.Parc Tauli

    Sabadell, 08208

    Recruiting

Other trials in Spain

Italy8 sites, 8 recruiting

  • Cliniche Humanitas Gavazzeni

    Bergamo, 24125

    Recruiting

  • ASST Spedali Civili Brescia

    Brescia, 25123

    Recruiting

  • SPDC Villa Scassi

    Genova, 16149

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Naples, 80131

    Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

    Recruiting

  • Aou San Luigi Gonzaga

    Sanatorio San Luigi, 10043

    Recruiting

  • Ospedale S. Maria Della Misericordia

    Udine, 33100

    Recruiting

Other trials in Italy

Japan8 sites, 8 recruiting

  • Juntendo University Hospital

    Bunkyō City, 113 8431

    Recruiting

  • Funabashi Municipal Medical Center

    Funabashi Shi, 273 8588

    Recruiting

  • Hakodate Goryoukaku Hospital

    Hakodate, 040 8611

    Recruiting

  • St Marianna University Hospital

    Kawasaki, 216 8511

    Recruiting

  • The Jikei University Hospital

    Minatoku, 105 8471

    Recruiting

  • Toho University Sakura Medical Center

    Sakura, 285-8741

    Recruiting

  • Yokohama Municipal Citizen's Hospital

    Yokohama, 221 0855

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232 0024

    Recruiting

Other trials in Japan

France7 sites, 7 recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Recruiting

  • Hopital Saint Louis

    Paris, 75010

    Recruiting

  • CHU Pitie Salpetriere

    Paris, 75013

    Recruiting

  • Hopital Saint Joseph

    Paris, 75014

    Recruiting

  • Clinique de la Croix du Sud

    Quint-Fonsegrives, 31130

    Recruiting

  • CHP Saint Gregoire

    Saint-Grégoire, 35768

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Recruiting

Other trials in France

Germany6 sites, 6 recruiting

  • Universitaetsklinikum Koeln

    Cologne, 50937

    Recruiting

  • Marien hospital Herne

    Herne, 44625

    Recruiting

  • Klinikum Leverkusen gGmbH

    Leverkusen, 51375

    Recruiting

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

    Recruiting

  • Studienpraxis Urologie Nurtingen

    Nürtingen, 72622

    Recruiting

  • Caritas-Krankenhaus St. Josef

    Regensburg, 93053

    Recruiting

Other trials in Germany

Israel6 sites, 6 recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

  • Carmel Medical Center

    Haifa, 3436212

    Recruiting

  • Meir Medical Center

    Kfar Saba, 44281

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Recruiting

Other trials in Israel

Argentina5 sites, 5 recruiting

  • Hospital Sirio Libanes

    Buenos Aires, C1419AHN

    Recruiting

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ

    Recruiting

  • Investigaciones Clinico Moleculares (ICM)

    Caba, C1425

    Recruiting

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH

    Recruiting

  • Sanatorio de la Mujer

    Rosario, 2000

    Recruiting

Other trials in Argentina

Belgium5 sites, 5 recruiting

  • Hopital Erasme

    Brussels, 1070

    Recruiting

  • Ziekenhuis Oost-Limburg

    Genk, 3600

    Recruiting

  • AZ Maria Middelares

    Ghent, 9000

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Brazil5 sites, 5 recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

    Recruiting

  • Hospital Regional do Cancer Hospital de Esperanca

    Presidente Prudente, 19013-050

    Recruiting

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

    Recruiting

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000

    Recruiting

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01323 010

    Recruiting

Other trials in Brazil

Greece5 sites, 5 recruiting

  • General Hospital of Athens G Gennimatas

    Athens, 115 27

    Recruiting

  • Laiko General Hospital of Athens

    Athens, 115 27

    Recruiting

  • Sismanogleio General Hospital

    Athens, 15126

    Recruiting

  • General Hospital Of Thessaloniki Papageorgiou

    Thessaloniki, 56429

    Recruiting

  • Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 57001

    Recruiting

Other trials in Greece

South Korea5 sites, 5 recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644

    Recruiting

  • Samsung Medical Center

    Gangnam Gu, 06351

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

Other trials in South Korea

United Kingdom5 sites, 5 recruiting

  • Hull University Teaching Hospitals NHS Trust

    Cottingham, HU16 5JQ

    Recruiting

  • St Bartholomews Hospital

    London, EC1A 7BE

    Recruiting

  • Southampton University Hospital

    Southampton, SO16 6HU

    Recruiting

  • Lister Hospital

    Stevenage, SG1 4AB

    Recruiting

  • Royal Marsden Hospital

    Surrey, SM2 5PT

    Recruiting

Other trials in United Kingdom

Netherlands4 sites, 4 recruiting

  • Radboud Umcn

    Nijmegen, 6525 GA

    Recruiting

  • Canisius-Wilhelmina ZH

    Nijmegen, 6532 SZ

    Recruiting

  • Erasmus MC

    Rotterdam, 3015

    Recruiting

  • UMC Utrecht

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

About this study

Official title: 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)

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).

Being tested
TAR-210, Mitomycin C, Gemcitabine
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAR-210Drug

    Also called JNJ-42756493

    TAR-210 will be administered intravesically.

  • Mitomycin CDrug

    MMC will be administered intravesically.

  • GemcitabineDrug

    Gemcitabine will be administered intravesically.

Study groups in NCT06919965
Study groupRoleWhat they receive
Group A: TAR-210ExperimentalParticipants 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.
Receives: Drug: TAR-210
Group B: Mitomycin C (MMC) or GemcitabineActive 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.
Receives: Drug: Mitomycin C; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (13)

  1. Recurrence-Free Survival (RFS)

    RFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1, or CIS), or death due to any cause, whichever occurs first.

    Measured: Up to 5 years

  2. Time to Next Intervention (TTNI)

    TTNI (i.e., transurethral resection of bladder tumor [TURBT], radical cystectomy [RC], radiation therapy [RT], or chemotherapy) is measured as the time from randomization to the date of next intervention (localized or systemic) for the treatment of urothelial carcinoma (UC).

    Measured: Up to 5 years

  3. Time to Disease Worsening (TTDW)

    TTDW is measured as the time from randomization to the date of cystectomy, systemic therapy, or radiation therapy, whichever occurs first.

    Measured: Up to 5 years

  4. Time to Progression (TTP)

    TTP is measured as the time from randomization to the date of first documented evidence of disease progression (i.e., progression to muscle-invasive bladder cancer [MIBC] [T greater than or equal to {>=} 2], lymph node [N+], or distant disease [M+]), or death due to disease progression, whichever occurs first.

    Measured: Up to 5 years

  5. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to 5 years

  6. Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Number of participants with AEs by severity grade as assessed by CTCAE version 5.0 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event.

    Measured: Up to 5 years

  7. Number of Participants With Change from Baseline in Laboratory Abnormalities

    Number of participants with change from baseline in laboratory abnormalities (hematology, serum chemistry and urine analysis) will be reported.

    Measured: Up to 5 years

  8. Number of Participants With Change from Baseline in Vital Signs Abnormalities

    Number of participants with change from baseline in vital signs (temperature, pulse/heart rate, respiratory rate and blood pressure) will be reported.

    Measured: Up to 5 years

  9. Change from Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-C30 Scores

    EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), a global health status or HRQoL scale and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicate greater functioning, better global health status, or more severe symptoms.

    Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  10. Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores

    EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores represent a high level of symptoms or problems, except for sexual function and sexual enjoyment, where a higher score represents a higher level of functioning.

    Measured: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  11. Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-C30 Scores

    EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), a global health status or HRQoL scale and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicate greater functioning, better global health status, or more severe symptoms.

    Measured: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  12. Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores

    EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores represent a high level of symptoms or problems, except for sexual function and sexual enjoyment, where a higher score represents a higher level of functioning.

    Measured: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  13. Number of Participants with Overall Side Effects Measured by EORTC Question 168 (Q168)

    EORTC Q168 is a single item from the EORTC item library used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Higher score indicates greater impact.

    Measured: Up to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2025
  2. Study start10 Sep 2025
  3. Primary completion6 Apr 2028 (estimated)
  4. Study completion16 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06919965
Sponsor's protocol ID
42756493BLC3005
Other IDs
42756493BLC3005, 2024-519493-39-00
Acronym
MoonRISe-3
Status last verified
Sep 2026
First submitted
2 Apr 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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