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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Hopital 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
        • Universitätsklinikum Münster
      • 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 Garcia 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 Oncología
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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