A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (SunRISe-1)

August 27, 2026 updated by: Janssen Research & Development, LLC

Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Bladder cancer is the tenth most common type of cancer worldwide. The natural history of high-risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) is unpredictable; rates of recurrence vary from 15 percent (%) to 78%, and rates of progression to muscle invasion and metastasis vary from less than (<) 1 to 45%. The gemcitabine 225 milligrams (mg) intravesical delivery system (JNJ-17000139) product (hereafter, TAR-200) is an investigational integral product that is comprised of a drug and device components. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein 1 (PD-1). This study consists 3 periods: screening phase (up to 42 days); treatment phase (up to 2 years); follow up phase (up to 5 years). Total duration of study is up to 6 year and 7 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Flinders Medical Centre
      • Box Hill, Australia, 3128
        • Eastern Health Research
      • Sydney, Australia, 2109
        • Macquarie University Hospital
  • Belgium
      • Assebroek, Belgium, 8310
        • AZ Sint-Lucas Brugge
      • Bruges, Belgium, 8000
        • AZ Sint-Jan Brugge
      • Brussels, Belgium, 1070
        • Hopital Erasme
      • Ghent, Belgium, 9000
        • Algemeen Ziekenhuis Maria Middelares
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Roeselare, Belgium, 8800
        • Algemeen Ziekenhuis Delta
      • Sint-Niklaas, Belgium, 9100
        • AZ Nikolaas
  • Canada
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Canada, V2S 3N5
        • Exdeo Clinical Research Inc
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital- UHN
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
      • Sherbrooke, Quebec, Canada, J1H 5H3
        • Université de Sherbrooke
  • France
      • Bordeaux, France, 33076
        • Hopital Pellegrin CHU Bordeaux
      • Bordeaux, France, 33300
        • Polyclinique Bordeaux Nord Acquitaine
      • Grenoble, France, 38043
        • CHU Grenoble
      • Hyères, France, 83400
        • Clinique Sainte Marguerite
      • Limoges, France, 87000
        • Polyclinique de Limoges - Francois Chenieux
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Marseille, France, 13273
        • Institut Paoli-Calmettes
      • Montpellier, France, 34070
        • Centre de Cancérologie du Grand Montpellier
      • Nîmes, France, 30029
        • CHU Nîmes
      • Paris, France, 75010
        • Hôpital Saint Louis
      • Paris, France, 75015
        • Hôpital Européen Georges-Pompidou
      • Paris, France, 75013
        • Hôpital Universitaire Pitié-Salpêtrière
      • Paris, France, 75877
        • Hopital Bichat Claude Bernard
      • Paris, France, 75020
        • Groupe Hospitalier Diaconesses Croix Saint Simon
      • Quint-Fonsegrives, France, 31130
        • Clinical La Croix Du Sud - Ramsay Santé
      • Rennes, France, 35033
        • Hôpital Pontchaillou
      • Saint-Grégoire, France, 35760
        • CHP Saint Grégoire
      • Strasbourg, France, 67200
        • Institut de Cancerologie Strasbourg Europe ICANS
      • Suresnes, France, 92151
        • Hôpital Foch
      • Toulouse, France, 31059
        • Hopital Rangueil
  • Germany
      • Cologne, Germany, 50968
        • Urologische Partnerschaft Koln UPK
      • Duisburg, Germany, 47169
        • Urologicum Duisburg
      • Herne, Germany, 44625
        • Klinikum Herne - Urologie
      • Markkleeberg, Germany, 04416
        • Matthias Schulze - Germany
      • Mettmann, Germany, 40822
        • Urologie Neandertal Praxis Mettmann
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Nuremberg, Germany, 90491
        • Schön Klinik Nürnberg Fürth
      • Nürtingen, Germany, 72622
        • Studienpraxis Urologie Nürtingen - Germany
      • Würselen, Germany, 52146
        • Urologische Praxis am Wasserturm - Germany
  • Greece
      • Cholargós, Greece, 155 62
        • Metropolitan General A E
      • Marousi, Greece, 151 25
        • Athens Medical Center
      • Thessaloniki, Greece, 54645
        • Euromedica General Clinic
      • Thessaloniki, Greece, 546 22
        • Bioclinic - Thessaloniki
      • Thessaloniki, Greece, 54635
        • General Hospital of Thessaloniki G. Gennimatas
      • Thessaloniki, Greece, TK 56403
        • Papageorgiou General Hospital of Thessaloniki
  • Italy
      • Bari, Italy, 70120
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
      • Bari, Italy, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Satellite 1
      • Florence, Italy, 50135
        • Azienda Ospedaliera Universitaria Careggi
      • Genova, Italy, 16132
        • Ospedale San Martino 1
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy, 00189
        • Azienda Ospedaliera Sant Andrea
      • Rome, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena
      • Torino, Italy, 10126
        • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo
  • Japan
      • Iizuka, Japan, 820-8501
        • Aso Co.,Ltd Iizuka Hospital
      • Kanagawa, Japan, 216 8511
        • St Marianna University Hospital
      • Kashihara-shi, Japan, 634-8522
        • Nara Medical University Hospital
      • Kisarazu-shi, Japan, 292-8535
        • Kimitsu Chuo Hospital
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Osaka, Japan, 591-8025
        • JOHAS Osaka Rosai Hospital
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Toyama, Japan, 930-0194
        • Toyama University Hospital
      • Toyoake, Japan, 470-1192
        • Fujita Health University Hospital
      • Tsukuba, Japan, 305-8520
        • University of Tsukuba Hospital
      • Yokohama, Japan, 232 0024
        • Yokohama City University Medical Center
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoek
      • Eindhoven, Netherlands, 5623EJ
        • Catharina ziekenhuis
      • Nijmegen, Netherlands, 6532SZ
        • Canisius-Wilhelmina Ziekenhuis
      • Utrecht, Netherlands, 3508 GA
        • The Julius Center - Utrecht Science Park - Stratenum
  • Portugal
      • Almada, Portugal, 2805-267
        • Hospital García de Orta
      • Aveiro, Portugal, 3810-193
        • Uls Regiao Aveiro - Hosp. Infante D. Pedro
      • Guimarães, Portugal, 4835-044
        • Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
      • Lisbon, Portugal, 1400-038
        • Fund. Champalimaud
      • Lisbon, Portugal, 1150-199
        • Centro Hospitalar de Lisboa Central
      • Loures, Portugal, 2674 514
        • Uls Loures Odivelas - Hosp. Loures
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil
      • Vila Nova de Gaia, Portugal, 4434 502
        • Centro Hospitalar de Vila Nova de Gaia Espinho E P E
      • Vila Real, Portugal, 5000508
        • Centro Hospitalar de Trás os Montes e Alto-Douro
  • Russia
      • Moscow, Russia, 125284
        • Hertzen Oncology Research Institute
      • Nizhny Novgorod, Russia, 603074
        • Privolzhsky District Medical Centre
      • Novosibirsk, Russia, 630099
        • Avicenna Medical Center
      • Obninsk, Russia, 249031
        • A. Tsyb Medical Radiological Research Center
      • Omsk, Russia, 644013
        • BHI of Omsk region Clinical Oncology Dispensary
      • Pyatigorsk, Russia, 357502
        • Ultrasound Clinic 4D
      • Saratov, Russia, 410054
        • Saratov State Medical University
      • Tyumen, Russia, 625041
        • Multifunctional clinical medical center 'Medical city'
      • Ufa, Russia, 450008
        • Bashkir State Medical University
  • South Korea
      • Busan, South Korea, 612-896
        • Inje University Haeundae Paik Hospital
      • Daegu, South Korea, 42601
        • Keimyung University Dongsan Hospital
      • Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Gwangju, South Korea, 61469
        • Chonnam National University Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St Mary s Hospital
      • Yangsan, South Korea, 50612
        • Pusan National University Yangsan Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Hosp Univ A Coruna
      • Badalona, Spain, 08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spain, 08025
        • Fund. Puigvert
      • Cadiz, Spain, 11009
        • Hosp. Puerta Del Mar
      • Granada, Spain, 18014
        • Hosp. Univ. Virgen de Las Nieves
      • Jerez de la Frontera, Spain, 11407
        • Hosp. de Jerez de La Frontera
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28046
        • Hosp. Univ. La Paz
      • Madrid, Spain, 28050
        • Hosp Univ Hm Sanchinarro
      • Málaga, Spain, 29010
        • Hosp Virgen de La Victoria
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • Chernihivskyi oblasnyi onkolohichnyi dyspanser
      • Kiev, Ukraine, 08173
        • Asklepion LLC
      • Sumy, Ukraine, 40022
        • Sumy Regional Clinical Oncology Centre
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • NHS Greater Glasgow and Clyde
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Del Sol Research Management, LLC
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Sherman Oaks, California, United States, 91411
        • Genesis Healthcare Partners - Genesis Research Greater Los Angeles
    • Colorado
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
      • Golden, Colorado, United States, 80401
        • Foothills Urology - Golden Off
    • Illinois
      • Lisle, Illinois, United States, 60532
        • DuPage Medical Group
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Urology of Indiana
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Wichita Urology Group
    • Michigan
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology
    • New York
      • New York, New York, United States, 10017
        • NYU Langone Health
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals
      • Syracuse, New York, United States, 13210-2375
        • SUNY Upstate Medical University
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • The Urology Group
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Urologic Consultants of Southeastern Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37209
        • Urology Associates, PC
    • Texas
      • Austin, Texas, United States, 78745
        • Urology Austin
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research
    • Washington
      • Spokane, Washington, United States, 99202
        • Spokane Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ [CIS] or tumor in situ [Tis]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)
  • All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma [HGUC])
  • Participants must be ineligible for or have elected not to undergo radical cystectomy
  • BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

Exclusion Criteria:

  • Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
  • Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
  • Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed
  • Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)
  • Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: TAR-200 and Cetrelimab
TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).
Drug: TAR-200
TAR-200 will be administered transuretherally.
Other Names:
  • JNJ-17000139
  • Gemcitabine-Releasing Intravesical System
Biological: Cetrelimab
Cetrelimab will be administered.
Other Names:
  • JNJ-63723283
Experimental: Cohort 2: TAR-200
TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Drug: TAR-200
TAR-200 will be administered transuretherally.
Other Names:
  • JNJ-17000139
  • Gemcitabine-Releasing Intravesical System
Experimental: Cohort 3: Cetrelimab
Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).
Biological: Cetrelimab
Cetrelimab will be administered.
Other Names:
  • JNJ-63723283
Experimental: Cohort 4: TAR-200 (Participants with Papillary Disease only)
TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Drug: TAR-200
TAR-200 will be administered transuretherally.
Other Names:
  • JNJ-17000139
  • Gemcitabine-Releasing Intravesical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
Time Frame: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Cohort 4: Disease-free Survival (DFS)
Time Frame: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to [>=] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause.
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response
Time Frame: From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response were reported.
From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
Overall Survival (OS)
Time Frame: From Week 0 up to 6 years 7 months
From Week 0 up to 6 years 7 months
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Time Frame: Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose
Plasma concentrations of gemcitabine and dFdU were reported.
Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose
Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)
Time Frame: At Week 0
Cmax was defined as maximum observed urine concentration.
At Week 0
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Time Frame: At Weeks 3, 6, 9, 15, 18, and 21
Urine concentrations of gemcitabine and dFdU were reported.
At Weeks 3, 6, 9, 15, 18, and 21
Cohort 1and 3: Serum Concentration of Cetrelimab
Time Frame: At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]
Serum concentration of cetrelimab were reported.
At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]
Cohort 3: Serum Concentration of Cetrelimab
Time Frame: At Weeks 60 (EOI)
Serum concentration of cetrelimab were reported.
At Weeks 60 (EOI)
Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies
Time Frame: From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis.
From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
Time Frame: From Week 0 up to 6 years 7 months
From Week 0 up to 6 years 7 months
Change From Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Time Frame: From Week 0 up to 6 years 7 months
From Week 0 up to 6 years 7 months
Time to Symptom Deterioration as Assessed by European Organisation for Research and Treatment of Cancer Qualityof-life Questionnaire (EORTC QLQ) -C30 Scores
Time Frame: From Week 0 up to 6 years 7 months
From Week 0 up to 6 years 7 months
Time to Symptom Deterioration as Assessed by EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Time Frame: From Week 0 up to 6 years 7 months
From Week 0 up to 6 years 7 months
Number of Participants With Adverse Events (AEs) by Severity Grades
Time Frame: From Week 0 up to 6 years 7 months
From Week 0 up to 6 years 7 months
Number of Participants With Clinical Laboratory Abnormalities by Severity Grades
Time Frame: From Week 0 up to 6 years 7 months
From Week 0 up to 6 years 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Actual)

July 3, 2025

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

November 20, 2020

First Submitted That Met QC Criteria

November 20, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108921
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2020-002646-16 (EudraCT Number)
  • 17000139BLC2001 (Other Identifier: Janssen Research & Development, LLC)
  • 2023-506146-23-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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