AzTrials
AzTrials

Non-Muscle Invasive Bladder NeoplasmsPhase 3MoonRISe-1NCT06319820

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

A Phase 3 study testing TAR-210, Gemcitabine and MMC in people with Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC at 193 sites in 20 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 between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC. 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, Gemcitabine and MMC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
641 participants
Where
193 sitesin 20 countries
Study dates
18 Apr 2024to 31 Dec 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

193 sites in 20 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

193 sites in 20 countries

United States38 sites

  • University of Colorado Cancer Center Anschultz Cancer Pavilion

    Aurora, Colorado, 80045

    Completed

  • Urology Austin

    Austin, Texas, 78745

    Active, not recruiting

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

    Completed

  • Brigham And Women's Hospital

    Boston, Massachusetts, 02115

    Completed

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Active, not recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Completed

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

    Active, not recruiting

  • UT Southwestern

    Dallas, Texas, 75390

    Completed

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Active, not recruiting

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138

    Active, not recruiting

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076

    Completed

  • Houston Metro Urology

    Houston, Texas, 77027

    Active, not recruiting

  • First Urology

    Jeffersonville, Indiana, 47130

    Completed

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

    Completed

  • Colorado Clinical Research

    Lakewood, Colorado, 80228

    Active, not recruiting

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

    Active, not recruiting

  • Arkansas Urology

    Little Rock, Arkansas, 72211

    Completed

  • Genesis Research LLC

    Los Alamitos, California, 90720

    Active, not recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Active, not recruiting

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

    Active, not recruiting

  • Urology Associates

    Nashville, Tennessee, 37209

    Active, not recruiting

  • Cancer Institute Of New Jersey

    New Brunswick, New Jersey, 08901

    Active, not recruiting

  • Ochsner Health System

    New Orleans, Louisiana, 70121-2429

    Active, not recruiting

  • Integrated Medical Professionals

    New York, New York, 10016

    Completed

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Active, not recruiting

  • The Urology Center, PC

    Omaha, Nebraska, 68114

    Active, not recruiting

  • University of California Irvine Medical Center

    Orange, California, 92868

    Active, not recruiting

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

    Active, not recruiting

  • Comprehensive Urology

    Royal Oak, Michigan, 48073

    Active, not recruiting

  • Om Research LLC

    San Diego, California, 92123

    Active, not recruiting

  • Genesis Research LLC 1

    Sherman Oaks, California, 91411

    Completed

  • Spokane Urology

    Spokane, Washington, 99202

    Active, not recruiting

  • Mercy Research

    St Louis, Missouri, 63141

    Completed

  • Specialty Clinical Research of St Louis

    St Louis, Missouri, 63141

    Active, not recruiting

  • Associated Medical Professionals of Ny

    Syracuse, New York, 13210

    Active, not recruiting

  • SUNY Upstate Med Univ

    Syracuse, New York, 13210

    Active, not recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Active, not recruiting

  • Wichita Urology Group

    Wichita, Kansas, 67226

    Active, not recruiting

Other trials in United States

China17 sites

  • Beijing Friendship Hospital Capital Medical University

    Beijing, 100050

    Active, not recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Active, not recruiting

  • Hunan Cancer hospital

    Changsha, 410013

    Active, not recruiting

  • The Third People's Hospital of Chengdu

    Cheng Du Shi, 610014

    Active, not recruiting

  • West China School of Medicine/West China Hospital, Sichuan University

    Cheng Du Shi, 610041

    Active, not recruiting

  • Chongqing Cancer Hospital

    Chongqing, 400033

    Active, not recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

    Active, not recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

    Active, not recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

    Active, not recruiting

  • Zhongda Hospital Southeast University

    Nanjing, 210009

    Active, not recruiting

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, 200031

    Active, not recruiting

  • The Second Hospital Of Tianjin Medical University

    Tianjin, 300061

    Active, not recruiting

  • Cancer Hospital of Xinjiang Medical University

    Ürümqi, 830011

    Active, not recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Active, not recruiting

  • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430032

    Active, not recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710063

    Active, not recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221004

    Active, not recruiting

Other trials in China

Spain16 sites, 12 recruiting

  • Hosp Univ A Coruna

    A Coruña, 15006

    Recruiting

  • Hosp. Univ. de La Ribera

    Alzira, 46600

    Recruiting

  • Fund. Puigvert

    Barcelona, 08025

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Completed

  • Hosp Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hosp. Puerta Del Mar

    Cadiz, 11009

    Recruiting

  • Hosp. Gral. Univ. de Castellon

    Castellon, 12004

    Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

    Recruiting

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

    Completed

  • Clinica Univ. de Navarra

    Madrid, 28027

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp Virgen de La Victoria

    Málaga, 29010

    Recruiting

  • Hosp. Univ. Central de Asturias

    Oviedo, 33011

    Completed

  • Hosp.Univ.Parc Tauli

    Sabadell, 08208

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, 41013

    Completed

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

Brazil11 sites

  • Fundacao Pio XII

    Barretos, 14780-070

    Active, not recruiting

  • Universidade Estadual De Campinas

    Campinas, 13083-888

    Completed

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

    Active, not recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

    Active, not recruiting

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050 170

    Active, not recruiting

  • HBA SA Assitencia Medica e Hospitalar

    Salvador, 41810-011

    Active, not recruiting

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650

    Active, not recruiting

  • Irmandade Santa Casa de Misericordia de Sao Paulo

    São Paulo, 01221-020

    Active, not recruiting

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

    São Paulo, 01246-000

    Active, not recruiting

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, 01323 900

    Active, not recruiting

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

    Completed

Other trials in Brazil

France11 sites, 9 recruiting

  • Hospital Center University De Lille

    Lille, 59000

    Completed

  • Polyclinique de Limoges - Francois Chenieux

    Limoges, 87000

    Recruiting

  • Hôpital Edouard Herriot

    Lyon, 69003

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Recruiting

  • Hopital Saint Louis

    Paris, 75010

    Recruiting

  • CHU Pitie Salpetriere

    Paris, 75013

    Recruiting

  • APHP - Hopital Bichat - Claude Bernard

    Paris, 75018

    Recruiting

  • Clinique de la Croix du Sud

    Quint-Fonsegrives, 31130

    Recruiting

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000

    Completed

  • CHU Rangueil

    Toulouse, 31059

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Germany11 sites, 5 recruiting

  • Charite - Universitaetsmedizin Berlin (CCM)

    Berlin, 10117

    Active, not recruiting

  • Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie

    Braunschweig, 38126

    Recruiting

  • Studienzentrum Bayenthal

    Cologne, 50968

    Recruiting

  • Urologische Gemeinschaftspraxis

    Dresden, 01307

    Completed

  • Universitaetsklinikum Frankfurt

    Frankfurt am Main, 60596

    Recruiting

  • Urologikum Hamburg MVZ - Germany

    Hamburg, 22081

    Active, not recruiting

  • Marien hospital Herne

    Herne, 44625

    Recruiting

  • Universitatsklinikum Jena

    Jena, 07747

    Active, not recruiting

  • Klinikum rechts der Isar an der Technischen Universitat Munchen

    München, 81675

    Completed

  • Klinikum St. Elisabeth Straubing GmbH

    Straubing, 94315

    Recruiting

  • Katharinenhospital Innere Medizin

    Stuttgart, 70174

    Completed

Other trials in Germany

Japan11 sites, 5 recruiting

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki Shi, 660 8550

    Active, not recruiting

  • St Marianna University Hospital

    Kawasaki Shi, 216 8511

    Recruiting

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047

    Active, not recruiting

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860 0008

    Active, not recruiting

  • Osaka International Cancer Institute

    Osaka, 541 8567

    Recruiting

  • Gunma Prefectural Cancer Center

    Ōta-ku, 373 8550

    Recruiting

  • Saitama Medical Center

    Saitama, 350 8550

    Active, not recruiting

  • JRC Wakayama Medical Center

    Wakayama, 640 8558

    Active, not recruiting

  • Yokohama Municipal Citizen's Hospital

    Yokohama, 221 0855

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232 0024

    Active, not recruiting

  • Yokosuka Kyosai Hospital

    Yokosuka, 238 8558

    Recruiting

Other trials in Japan

Poland10 sites, 6 recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15 276

    Recruiting

  • IN VIVO Sp. z o.o

    Bydgoszcz, 85 048

    Recruiting

  • Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85 796

    Completed

  • Uniwersytecki Szpital Kliniczny nr 4

    Lublin, 20 090

    Recruiting

  • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

    Przemyśl, 37 700

    Active, not recruiting

  • Szpital Wojewodzki Im Sw Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie

    Tarnów, 33-100

    Recruiting

  • Medicover Integrated Clinical Services Sp z o o

    Torun, 87-100

    Completed

  • Mazowiecki Szpital Onkologiczny Sp z o o

    Wieliszew, 05-135

    Recruiting

  • 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu

    Wroclaw, 50 981

    Completed

  • Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii

    Wroclaw, 53-413

    Recruiting

Other trials in Poland

Italy9 sites, 8 recruiting

  • Ospedale S. Donato Arezzo, USL 8 - U.O. Oncologia Medica

    Arezzo, 52100

    Recruiting

  • Cliniche Humanitas Gavazzeni

    Bergamo, 24125

    Recruiting

  • ASST Spedali Civili Brescia

    Brescia, 25123

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Completed

  • Istituto Dei Tumori Di Milano

    Milan, 20133

    Recruiting

  • Universita Campus Bio-Medico di Roma

    Roma, 00128

    Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • A.O.Citta della Salute e della Scienza di Torino

    Torino, 10126

    Recruiting

Other trials in Italy

Belgium7 sites, 5 recruiting

  • AZORG campus Aalst Moorselbaan

    Aalst, 9300

    Recruiting

  • AZ Sint-Jan

    Bruges, 8000

    Recruiting

  • UZ Antwerpen

    Edegem, 2650

    Completed

  • AZ Maria Middelares

    Ghent, 9000

    Recruiting

  • Universitair Ziekenhuis Gasthuisberg

    Leuven, 3000

    Active, not recruiting

  • Vitaz

    Sint-Niklaas, 9100

    Recruiting

  • CHU UCL Namur - Site Godinne

    Yvoir, 5530

    Recruiting

Other trials in Belgium

Turkey (Türkiye)7 sites, 4 recruiting

  • Adana Baskent Practice and Research Hospital

    Adana, 01120

    Completed

  • Ankara University Medical Faculty

    Ankara, 06100

    Completed

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200

    Recruiting

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34153

    Completed

  • T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

    Istanbul, 34722

    Recruiting

  • Kartal Dr Lutfi Kirdar sehir Hastanesi

    Istanbul, 34865

    Recruiting

  • Dokuz Eylul University Medical Faculty

    Izmir, 35330

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom7 sites, 7 recruiting

  • Southmead Hospital

    Bristol, BS105NB

    Recruiting

  • St Bartholomews Hospital

    London, EC1A 7BE

    Recruiting

  • Charing Cross Hospital

    London, W6 8RF

    Recruiting

  • Newcastle Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

    Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2SJ

    Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    Recruiting

  • Royal Marsden Hospital

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Argentina6 sites

  • Hospital Sirio Libanes

    Buenos Aires, C1419AHN

    Active, not recruiting

  • Investigaciones Clinico Moleculares (ICM)

    CABA, C1425

    Active, not recruiting

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000

    Active, not recruiting

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH

    Active, not recruiting

  • Hospital Privado de la Comunidad

    Mar del Plata, B7602

    Active, not recruiting

  • Sanatorio de la Mujer

    Rosario, 2000

    Active, not recruiting

Other trials in Argentina

South Korea6 sites, 4 recruiting

  • Chungbuk National University Hospital

    Chungcheongbuk Do, 28644

    Completed

  • National Cancer Center

    Gyeonggi-do, 10408

    Recruiting

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

    Active, not recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Recruiting

Other trials in South Korea

Austria5 sites, 5 recruiting

  • Medizinische Universitaet Graz

    Graz, 8036

    Recruiting

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

    Recruiting

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

    Recruiting

  • Universitaetsklinikum Salzburg Landeskrankenhaus

    Salzburg, 5020

    Recruiting

  • Medical University Vienna MUV

    Vienna, 1090

    Recruiting

Other trials in Austria

Czechia5 sites, 4 recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Completed

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

    Recruiting

  • Fakultni Thomayerova nemocnice

    Prague, 140 59

    Recruiting

  • Fakultni nemocnice v Motole

    Prague, 150 06

    Recruiting

Other trials in Czechia

Denmark5 sites, 5 recruiting

  • Aarhus University Hospital

    Aarhus, 8200

    Recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Recruiting

  • Herlev Hospital

    Herlev, 2730

    Recruiting

  • Odense Universitetshospital

    Odense, 5000

    Recruiting

  • Zealand University Hospital

    Roskilde, 4000

    Recruiting

Other trials in Denmark

Israel5 sites, 4 recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    Recruiting

  • Hadassah University Hospita Ein Kerem

    Jerusalem, 9112001

    Completed

  • Sheba Medical Center

    Ramat Gan, 52621

    Recruiting

  • Ziv Medical Center

    Safed, 13100

    Recruiting

  • Sourasky Medical Center

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Ireland4 sites

  • Cork University Hospital

    Cork, T12 DC4A

    Active, not recruiting

  • Mater Misericordiae University Hospital

    Dublin, D07 A8NN

    Active, not recruiting

  • Mater Private Hospital

    Dublin, D07 WKW8

    Active, not recruiting

  • Adelaide and Meath Hospital

    Dublin, D24 NR0A

    Active, not recruiting

Other trials in Ireland

Hong Kong2 sites

  • Prince Of Wales Hospital

    Hong Kong

    Active, not recruiting

  • Queen Mary Hospital

    Hong Kong

    Active, not recruiting

Other trials in Hong Kong

About this study

Official title: 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

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.

Being tested
TAR-210, Gemcitabine, MMC
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-210Combination product

    Also called JNJ-42756493

    TAR-210 will be administered intravesically.

  • GemcitabineDrug

    Gemcitabine will be administered intravesically.

  • MMCDrug

    MMC will be administered intravesically.

Study groups in NCT06319820
Study groupRoleWhat they receive
Main Study: Group A: TAR-210ExperimentalParticipants 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.
Receives: Combination Product: TAR-210
Main Study: Group B: 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 a maintenance phase for a minimum of 6 months and up to 1 year.
Receives: Drug: Gemcitabine; Drug: MMC
Substudy: Group A: TAR-210ExperimentalParticipants 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.
Receives: Combination Product: TAR-210
Substudy: Group B: MMCActive 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.
Receives: Drug: MMC

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 documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.

    Measured: From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)

Secondary outcomes (10)

  1. Time to next Treatment (TTNT)

    TTNT is measured as the time from randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer.

    Measured: From randomization to the date of first documented subsequent treatment (local, systemic, surgical, or interventional) for bladder cancer (approximately 4 years and 2 months)

  2. High Grade Recurrence-free Survival (HG RFS)

    HG RFS is measured as the time from randomization to the date of first documented evidence of HG NMIBC or death, whichever occurs first

    Measured: From randomization to the date of first documented evidence of HG NMIBC or death (approximately 4 years and 2 months)

  3. Progression Free Survival (PFS)

    PFS is measured as the time from randomization to the date of first documented evidence of disease progression or death, whichever occurs first.

    Measured: From randomization to the date of first documented disease progression or death (approximately 4 years and 2 months)

  4. Number of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment

    Number of diagnostic and therapeutic invasive urological interventions after study treatment, that is, endoscopic procedures (e.g., cystoscopies, transurethral resection of bladder tumors (TURBTs), ureteroscopies, urethral interventions, urethral stricture/bladder neck incision), catheterization (intravesical, suprapubic), intravesical treatments, major surgeries (e.g., radical cystectomy, simple cystectomy, urethroplasty) will be reported.

    Measured: From study treatment completion up to trial discontinuation (approximately 4 years and 2 months)

  5. Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities)

    An AE is any untoward medical occurrence in a participant participating in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product, that does not necessarily have a causal relationship with the treatment. AEs will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening and Grade 5: Death. Number of participants with adverse events (including physical examination, vital signs and laboratory abnormalities) will be reported.

    Measured: From first dose up to 30 days after last dose of study treatment (approximately 4 years and 2 months)

  6. Overall Survival (OS)

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

    Measured: From randomization to the date of death (approximately 4 years and 2 months)

  7. European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores

    EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

    Measured: Baseline, Weeks 6, 12, 24, 36, and 48

  8. European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores

    EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

    Measured: Baseline, Weeks 6, 12, 24, 36, and 48

  9. Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores

    EORTC QLQ-C30 is a core 30-item questionnaire for evaluating the HRQoL of participants participating in cancer clinical studies. It incorporates 5 functional scales (physical, role, cognitive, emotional, and social functioning), 3 symptom scales (fatigue, pain, and nausea or vomiting), and a global health status or HRQoL scale. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

    Measured: Weeks 6, 12, 24, 36, and 48

  10. Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores

    EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.

    Measured: Weeks 6, 12, 24, 36, and 48

Timeline

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

  1. First posted20 Mar 2024
  2. Study start18 Apr 2024
  3. Primary completion28 Jun 2028 (estimated)
  4. Study completion31 Dec 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
641 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06319820
Sponsor's protocol ID
42756493BLC3004
Acronym
MoonRISe-1
Status last verified
Sep 2026
First submitted
13 Mar 2024
Last updated
25 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAR-210, Gemcitabine and MMC in people with Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC at 193 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States, China, Spain, Brazil, France and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) (time frame: From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06319820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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