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)

April 23, 2024 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

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 (Estimated)

200

Phase

  • Phase 2

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 Locations

  • Australia
      • Bedford Park, Australia, 5042
        • Completed
        • Flinders Medical Centre
      • Box Hill, Australia, 3128
        • Completed
        • Eastern Health Research
      • Sydney, Australia, 2109
        • Recruiting
        • Macquarie University Hospital
  • Belgium
      • Assebroek, Belgium, 8310
        • Recruiting
        • Algemeen Ziekenhuis Sint-Jan
      • Brugge, Belgium, 8000
        • Recruiting
        • AZ St.-Jan Brugge-Oostende AV
      • Brussel, Belgium, 1070
        • Recruiting
        • Hopital Erasme
      • Gent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
      • Gent, Belgium, 9000
        • Recruiting
        • Algemeen Ziekenhuis Maria Middelares
      • Roeselare, Belgium, 8800
        • Recruiting
        • Algemeen Ziekenhuis Delta
      • Sint-Niklaas, Belgium, 9100
        • Recruiting
        • AZ Nikolaas
  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
        • Recruiting
        • Exdeo Clinical Research Inc
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Completed
        • William Osler Health System
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Hospital- UHN
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
      • Sherbrooke, Quebec, Canada, J1H 5H3
        • Recruiting
        • Université de Sherbrooke
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Hopital Pellegrin CHU Bordeaux
      • Bordeaux, France, 33300
        • Recruiting
        • Polyclinique Bordeaux Nord Acquitaine
      • Grenoble, France, 38043
        • Completed
        • CHU Grenoble
      • Hyeres, France, 83400
        • Recruiting
        • Clinique Sainte Marguerite
      • Limoges, France, 87000
        • Recruiting
        • Polyclinique de Limoges - Francois Chenieux
      • Lyon Cedex 03, France, 69437
        • Recruiting
        • Hôpital Edouard Herriot
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli-Calmettes
      • Montpellier, France, 34070
        • Recruiting
        • Centre de Cancérologie du Grand Montpellier
      • Nimes, France, 30029
        • Recruiting
        • CHU Nimes
      • Paris, France, 75010
        • Completed
        • Hôpital Saint Louis
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges-Pompidou
      • Paris, France, 75020
        • Recruiting
        • Groupe Hospitalier Diaconesses Croix Saint Simon
      • Paris, France, 75877
        • Recruiting
        • Hopital Bichat Claude Bernard
      • Paris Cedex 13, France, 75013
        • Recruiting
        • Hôpital Universitaire Pitié-Salpêtrière
      • Quint-Fonsegrives, France, 31130
        • Recruiting
        • Clinical La Croix Du Sud - Ramsay Santé
      • Rennes cedex 9, France, 35033
        • Recruiting
        • Hôpital Pontchaillou
      • Saint Gregoire, France, 35760
        • Recruiting
        • CHP Saint Grégoire
      • Strasbourg, France, 67200
        • Recruiting
        • Institut de Cancerologie Strasbourg Europe ICANS
      • Suresnes, France, 92151
        • Recruiting
        • Hôpital Foch
      • Toulouse, France, 31059
        • Recruiting
        • Hopital Rangueil
  • Germany
      • Duisburg, Germany, 47179
        • Recruiting
        • Urologicum Duisburg
      • Herne, Germany, 44625
        • Recruiting
        • Klinikum Herne - Urologie
      • Köln, Germany, 50968
        • Recruiting
        • Urologische Partnerschaft Koln UPK
      • Markkleeberg, Germany, 04416
        • Recruiting
        • Matthias Schulze - Germany
      • Mettmann, Germany, 40822
        • Recruiting
        • Urologie Neandertal Praxis Mettmann
      • Münster, Germany, 48149
        • Recruiting
        • Universitatsklinikum Munster
      • Nürnberg, Germany, 90491
        • Recruiting
        • Schön Klinik Nürnberg Fürth
      • Nürtingen, Germany, 72622
        • Recruiting
        • Studienpraxis Urologie Nürtingen - Germany
      • Würselen, Germany, 52146
        • Recruiting
        • Urologische Praxis am Wasserturm - Germany
  • Greece
      • Holargos, Greece, 155 62
        • Recruiting
        • Metropolitan General A.E.
      • Maroussi, Greece, 151 25
        • Recruiting
        • Athens Medical Center
      • Thessaloniki, Greece, 546 22
        • Recruiting
        • Bioclinic - Thessaloniki
      • Thessaloniki, Greece, 54645
        • Recruiting
        • Euromedica General Clinic
      • Thessaloniki, Greece, 54635
        • Recruiting
        • General Hospital of Thessaloniki G. Gennimatas
      • Thessaloniki, Greece, TK 56403
        • Recruiting
        • 'Papageorgiou' General Hospital of Thessaloniki
  • Italy
      • Firenze, Italy, 50135
        • Recruiting
        • Azienda ospedaliera universitaria Careggi
      • Genova, Italy, 16132
        • Completed
        • Ospedale San Martino
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy, 00189
        • Recruiting
        • Azienda Ospedaliera Sant Andrea
      • Rome, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena
      • Torino, Italy, 10126
        • Recruiting
        • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
      • Varese, Italy, 21100
        • Recruiting
        • Ospedale di Circolo e Fondazione Macchi
      • Vicenza, Italy, 36100
        • Completed
        • Ospedale San Bortolo
  • Japan
      • Iizuka, Japan, 820-8501
        • Completed
        • Aso Co.,Ltd Iizuka Hospital
      • Kanagawa, Japan, 216-8511
        • Completed
        • St Marianna University Hospital
      • Kashihara-shi, Japan, 634-8522
        • Recruiting
        • Nara Medical University Hospital
      • Kisarazu-shi, Japan, 292-8535
        • Recruiting
        • Kimitsu Chuo Hospital
      • Nagasaki-shi, Japan, 852-8501
        • Completed
        • Nagasaki University Hospital
      • Osaka, Japan, 591-8025
        • Recruiting
        • JOHAS Osaka Rosai Hospital
      • Tokyo, Japan, 105-8470
        • Recruiting
        • Toranomon Hospital
      • Toyama-shi, Japan, 930-0194
        • Recruiting
        • Toyama University Hospital
      • Toyoake, Japan, 470-1192
        • Completed
        • Fujita Health University Hospital
      • Tsukuba-Shi, Japan, 305-8520
        • Recruiting
        • University of Tsukuba Hospital
      • Yokohama, Japan, 232 0024
        • Recruiting
        • Yokohama City University Medical Center
  • Korea, Republic of
      • Busan, Korea, Republic of, 612-896
        • Recruiting
        • Inje University Haeundae Paik Hospital
      • Daegu, Korea, Republic of, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
      • Daegu, Korea, Republic of, 41404
        • Completed
        • Kyungpook National University Chilgok Hospital
      • Goyang-si, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
      • Gwangju, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 06273
        • Recruiting
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 03722
        • Completed
        • Severance Hospital
      • Seoul, Korea, Republic of, 06591
        • Completed
        • The Catholic University of Korea Seoul St. Mary'S Hospital
      • Yangsan Si, Korea, Republic of, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • NKI-AVL, Amsterdam
      • Eindhoven, Netherlands, 5623EJ
        • Completed
        • Catharina Ziekenhuis
      • Nijmegen, Netherlands, 6532SZ
        • Recruiting
        • Canisius-Wilhelmina Ziekenhuis
      • Utrecht, Netherlands, 3508 GA
        • Recruiting
        • The Julius Center - Utrecht Science Park - Stratenum
  • Portugal
      • Almada, Portugal, 2805-267
        • Recruiting
        • Hospital Garcia de Orta
      • Aveiro, Portugal, 3810-193
        • Completed
        • Chbv - Hosp. Infante D. Pedro
      • Guimarães, Portugal, 4835-044
        • Recruiting
        • Hosp. Sra. Da Oliveira - Guimaraes
      • Lisboa, Portugal, 1150-199
        • Completed
        • Centro Hospitalar de Lisboa Central
      • Lisbon, Portugal, 1400-038
        • Recruiting
        • Fundacao Champalimaud
      • Loures, Portugal, 2674 514
        • Completed
        • Hospital Beatriz Angelo
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil
      • Vila Nova de Gaia, Portugal, 4434 502
        • Recruiting
        • Centro Hospitalar de Vila Nova de Gaia Espinho E P E
      • Vila Real, Portugal, 5000508
        • Completed
        • Centro Hospitalar de Trás os Montes e Alto-Douro
  • Russian Federation
      • Moscow, Russian Federation, 125284
        • Terminated
        • Hertzen Oncology Research Institute
      • Nizhny Novgorod, Russian Federation, 603109
        • Suspended
        • City Clinical Hospital #1
      • Novosibirsk, Russian Federation, 630099
        • Suspended
        • Avicenna Medical Center
      • Obninsk, Russian Federation, 249031
        • Terminated
        • A. Tsyb Medical Radiological Research Center
      • Omsk, Russian Federation, 644013
        • Terminated
        • Bhi of Omsk Region Clinical Oncology Dispensary
      • Pyatigorsk, Russian Federation, 357502
        • Terminated
        • Ultrasound Clinic 4D
      • Saratov, Russian Federation, 410054
        • Terminated
        • Saratov State Medical University
      • Tyumen, Russian Federation, 625041
        • Terminated
        • Multifunctional clinical medical center 'Medical city'
      • Ufa, Russian Federation, 450008
        • Terminated
        • Bashkir State Medical University
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Hosp. Univ. A Coruna
      • Badalona, Spain, 08916
        • Recruiting
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona, Spain, 08025
        • Recruiting
        • Fund. Puigvert
      • Cadiz, Spain, 11009
        • Recruiting
        • Hosp. Puerta Del Mar
      • Granada, Spain, 18014
        • Recruiting
        • Hosp. Univ. Virgen de Las Nieves
      • Jerez De La Frontera, Spain, 11407
        • Recruiting
        • Hosp. de Jerez de La Frontera
      • Madrid, Spain, 28034
        • Recruiting
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28041
        • Recruiting
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28046
        • Recruiting
        • Hosp. Univ. La Paz
      • Madrid, Spain, 28660
        • Recruiting
        • Hosp. Univ. Hm Monteprincipe
      • Málaga, Spain, 29010
        • Recruiting
        • Hosp. Virgen de La Victoria
      • Sabadell, Spain, 08208
        • Recruiting
        • Corporacio Sanitari Parc Tauli
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncología
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • Terminated
        • Chernihivskyi oblasnyi onkolohichnyi dyspanser
      • Kiev, Ukraine, 08173
        • Terminated
        • Asklepion LLC
      • Sumy, Ukraine, 40022
        • Terminated
        • Sumy Regional Clinical Oncology Centre
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Completed
        • NHS Greater Glasgow and Clyde
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Teaching Hospitals NHS Trust
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Urological Associates of Southern Arizona, P.C.
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
      • Sherman Oaks, California, United States, 91411
        • Recruiting
        • Genesis Healthcare Partners - Genesis Research Greater Los Angeles
    • Colorado
      • Denver, Colorado, United States, 80211
        • Completed
        • The Urology Center Of Colorado
      • Golden, Colorado, United States, 80401
        • Recruiting
        • Foothills Urology - Golden Off
    • Illinois
      • Lisle, Illinois, United States, 60532
        • Completed
        • DuPage Medical Group
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Recruiting
        • Urology of Indiana
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Wichita Urology Group
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Michigan Institute of Urology
    • New York
      • New York, New York, United States, 10017
        • Recruiting
        • NYU Langone Health
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Associated Medical Professionals
      • Syracuse, New York, United States, 13210-2375
        • Recruiting
        • SUNY Upstate Medical University
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • The Urology Group
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • Urologic Consultants of Southeastern Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Completed
        • Thomas Jefferson University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates, PC
    • Texas
      • Austin, Texas, United States, 78745
        • Recruiting
        • Urology Austin
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Urology San Antonio Research
    • Washington
      • Spokane, Washington, United States, 99202
        • Completed
        • 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
Cohort 1, 2, and 3: Overall Complete Response (CR) Rate
Time Frame: Up to 5 years
Overall CR rate is defined as the percentage of participants achieving a CR at any time post-treatment. It will be measured by determining the percentage of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any time point.
Up to 5 years
Cohort 4: Disease-free Survival (DFS)
Time Frame: Up to 5 years
DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies
Time Frame: Predose, up to 3 years
Serum concentration of anti-cetrelimab antibodies will be assessed using a validated immunoassay for anti-drug antibody (ADA) analysis.
Predose, up to 3 years
Number of Participants with Anti-cetrelimab Antibodies
Time Frame: Predose, up to 3 years
Number of participants with anti-cetrelimab antibodies will be reported.
Predose, up to 3 years
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
Time Frame: Baseline, up to 3 years and 4 months
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).
Baseline, up to 3 years and 4 months
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Time Frame: Baseline, up to 3 years and 4 months
EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with superficial (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).
Baseline, up to 3 years and 4 months
Number of Participants with Adverse Events (AEs) by Severity Grades
Time Frame: Up to 5 years
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity grades ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Up to 5 years
Cohort 1, 2, and 3: Duration of Response (DOR)
Time Frame: Up to 5 years
DOR is defined from the date of first CR achieved to the date of first evidence of recurrence or progression or death (whichever is earlier) for participants who achieve a CR.
Up to 5 years
Overall Survival (OS)
Time Frame: Up to 5 years
OS, defined as the time from the date of first dose of study treatment to death; if a participant has not died at the time of analysis, the participant will be censored at the date last known alive.
Up to 5 years
Cohort 1, 2, and 4: Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma
Time Frame: Up to Week 21
Concentrations of gemcitabine and its metabolite dFdU in urine and plasma will be assessed.
Up to Week 21

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

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 (Estimated)

November 20, 2026

Study Completion (Estimated)

July 2, 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)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108921
  • 2020-002646-16 (EudraCT Number)
  • 17000139BLC2001 (Other Identifier: Janssen Research & Development, LLC)

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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