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SunRISe-1: 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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04640623
Collaborator
(none)
200
Enrollment
184
Locations
3
Arms
78.4
Anticipated Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 18, 2020
Anticipated Primary Completion Date :
Oct 24, 2024
Anticipated Study Completion Date :
Jul 2, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: TAR-200 and Cetrelimab

TAR-200 is placed into the bladder through a urinary placement catheter 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 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 will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).

    Biological: Cetrelimab
    Cetrelimab will be administered.
    Other Names:
  • JNJ-63723283

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Complete Response (CR) Rate [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.

    Secondary Outcome Measures

    1. Duration of Response (DOR) [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.

    2. Overall Survival (OS) [Up to 5 years]

      OS, defined as the time from randomization to death; if a participant has not died at the time of analysis, the participant will be censored at the date last known alive.

    3. Cohort 1 and 2: Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma [Up to Week 21]

      Concentrations of gemcitabine and its metabolite dFdU in urine and plasma will be assessed.

    4. Cohort 1 and 3: Serum Concentration of Anti-cetrelimab Antibodies [Predose, up to 3 years]

      Serum concentration of anti-cetrelimab antibodies will be assessed using a validated immunoassay for anti-drug antibody (ADA) analysis.

    5. Number of Participants with Anti-cetrelimab Antibodies [Predose, up to 3 years]

      Number of participants with anti-cetrelimab antibodies will be reported.

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

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

    8. Number of Participants with Adverse Events (AEs) by Severity Grades [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed diagnosis of persistent or recurrent (carcinoma in situ [CIS] or Tumour in situ [Tis]), with or without papillary disease (T1, high-grade Ta) 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 (example, less than (<) 20 percent (%) variant histologic subtype). 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 acceptable) and documented in the electronic case report form (eCRF) at screening cystoscopy

    • 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:

    • 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

    • Participants with an active, known or suspected autoimmune disease. Participants with autoimmune disorders not requiring systemic treatment (example, skin conditions such as vitiligo, psoriasis, alopecia) or conditions requiring hormonal replacement therapies such as type 1 diabetes mellitus or hypothyroidism are permitted to enroll

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bladder Cancer Genitourinary Oncology Phoenix Arizona United States 85032
    2 Urological Associates of Southern Arizona, P.C. Tucson Arizona United States 85715
    3 University of Southern California Los Angeles California United States 90033
    4 The Urology Center of Colorado Denver Colorado United States 80211
    5 Foothills Urology - Golden Off Golden Colorado United States 80401
    6 DuPage Medical Group Lisle Illinois United States 60532
    7 Indiana University Indianapolis Indiana United States 46202-5116
    8 Johns Hopkins Medical Institutions Baltimore Maryland United States 21287
    9 University of Michigan Ann Arbor Michigan United States 48109-5000
    10 Wayne State University Detroit Michigan United States 48202
    11 Michigan Institute of Urology Troy Michigan United States 48084
    12 Delaware Valley Urology, LLC. Voorhees New Jersey United States 08043
    13 NYU Langone Health New York New York United States 10017
    14 University of Rochester Rochester New York United States 14627
    15 SUNY Upstate Medical University Syracuse New York United States 13210-2375
    16 Associated Medical Professionals Syracuse New York United States 13210
    17 Levine Cancer Institute Charlotte North Carolina United States 28204
    18 Wake Forest Health Sciences Winston-Salem North Carolina United States 27103
    19 The Urology Group Cincinnati Ohio United States 45212
    20 Oregon Urology Institute Springfield Oregon United States 97477
    21 Urologic Consultants of Southeastern Pennsylvania Bala-Cynwyd Pennsylvania United States 19004
    22 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    23 Urology Associates, PC Nashville Tennessee United States 37209
    24 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    25 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    26 Urology San Antonio Research San Antonio Texas United States 78229
    27 Spokane Urology Spokane Washington United States 99202
    28 Flinders Medical Centre Bedford Park Australia 5042
    29 Eastern Health Research Box Hill Australia 3128
    30 Prince Of Wales Hospital Randwick Australia 2031
    31 Royal North Shore Hospital St Leonards Australia 2065
    32 Macquarie University Hospital Sydney Australia 2109
    33 Princess Alexandra Hospital Woolloongabba Australia 4102
    34 Algemeen Ziekenhuis Sint-Jan Assebroek Belgium 8310
    35 AZ St.-Jan Brugge-Oostende AV Brugge Belgium 8000
    36 Hopital Erasme Brussel Belgium 1070
    37 Universitair Ziekenhuis Gent Gent Belgium 9000
    38 Algemeen Ziekenhuis Delta Roeselare Belgium 8800
    39 AZ Nikolaas Sint-Niklaas Belgium 9100
    40 Exdeo Clinical Research Inc Abbotsford British Columbia Canada V2S 3N5
    41 The Male/Female Health and Research Centre Barrie Ontario Canada L4M 7G1
    42 William Osler Health System Brampton Ontario Canada L6R 3J7
    43 Princess Margaret Hospital- UHN Toronto Ontario Canada M5G 2M9
    44 McGill University Health Centre Montreal Quebec Canada H4A 3J1
    45 Universite de Sherbrooke Sherbrooke Quebec Canada J1H 5H3
    46 Polyclinique Bordeaux Nord Acquitaine Bordeaux France 33300
    47 Hôpital Côte de Nacre Caen cedex 9 France 14033
    48 CHU Grenoble Grenoble France 38043
    49 Clinique Sainte Marguerite Hyeres France 83400
    50 Polyclinique de Limoges - Francois Chenieux Limoges France 87000
    51 Hôpital Edouard Herriot Lyon Cedex 03 France 69437
    52 Institut Paoli-Calmettes Marseille France 13273
    53 CHU Nîmes Nimes France 30029
    54 Hôpital Universitaire Pitié-Salpêtrière Paris Cedex 13 France 75013
    55 Hopital Saint-Louis Paris France 75010
    56 Hopital Europeen Georges-Pompidou Paris France 75015
    57 Groupe Hospitalier Diaconesses Croix Saint Simon Paris France 75020
    58 Hopital Bichat Claude Bernard Paris France 75877
    59 CHU De Poitiers Poitiers France 86021
    60 Hopital Pontchaillou Rennes cedex 9 France 35033
    61 CHP Saint Gregoire Saint Gregoire France 35760
    62 Institut de Cancérologie Strasbourg Europe (ICANS) Strasbourg France 67200
    63 Hopital Foch Suresnes France 92151
    64 Hopital Rangueil Toulouse France 31059
    65 Urologicum Duisburg Duisburg Germany 47179
    66 Klinikum Herne - Urologie Herne Germany 44625
    67 Uniklinik Köln Köln Germany 50937
    68 Urologische Partnerschaft Köln UPK Köln Germany 50968
    69 Matthias Schulze - Germany Markkleeberg Germany 04416
    70 Urologie Neandertal Praxis Mettmann Mettmann Germany 40822
    71 Universitätsklinikum Münster Münster Germany 48149
    72 Schön Klinik Nürnberg Fürth Nürnberg Germany 90491
    73 Studienpraxis Urologie Nürtingen - Germany Nürtingen Germany 72622
    74 Kliniken Nordoberpfalz AG/Klinikum Weiden Weiden Germany 92637
    75 Urologische Praxis am Wasserturm - Germany Würselen Germany 52146
    76 Attikon University General Hospital of Attica Athens Greece 12462
    77 Metropolitan General A.E. Holargos Greece 155 62
    78 Athens Medical Center Maroussi Greece 151 25
    79 Bioclinic - Thessaloniki Thessaloniki Greece 546 22
    80 General Hospital of Thessaloniki G. Gennimatas Thessaloniki Greece 54635
    81 Euromedica General Clinic Thessaloniki Greece 54645
    82 'Papageorgiou' General Hospital of Thessaloniki Thessaloniki Greece TK 56403
    83 Policlinico Abano Terme Abano Terme Italy 35031
    84 Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy 70120
    85 Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy 70124
    86 Azienda Ospedaliera Universitaria Careggi Firenze Italy 50135
    87 Ospedale San Martino Genova Italy 16132
    88 Ospedale San Raffaele Milan Italy 20132
    89 Azienda Ospedaliero Universitaria Pisana Pisa Italy 56126
    90 Azienda Ospedaliera Sant Andrea Roma Italy 00189
    91 Istituto Nazionale Tumori Regina Elena Rome Italy 00144
    92 Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino Italy 10126
    93 Ospedale di Circolo e Fondazione Macchi Varese Italy 21100
    94 Ospedale San Bortolo Vicenza Italy 36100
    95 Aso Co.,Ltd Iizuka Hospital Iizuka Japan 820-8501
    96 St.Marianna University Hospital Kanagawa Japan 216-8511
    97 Kimitsu Chuo Hospital Kisarazu-shi Japan 292-8535
    98 Nagasaki University Hospital Nagasaki-shi Japan 852-8501
    99 JOHAS Osaka Rosai Hospital Osaka Japan 591-8025
    100 Toranomon Hospital Tokyo Japan 105-8470
    101 Toyama University Hospital Toyama-shi Japan 930-0194
    102 Fujita Health University Hospital Toyoake Japan 470-1192
    103 University of Tsukuba Hospital Tsukuba-Shi Japan 305-8520
    104 Yamaguchi University Hospital Ube Japan 755-8505
    105 Yokohama City University Medical Center Yokohama Japan 232-0024
    106 Inje University Haeundae Paik Hospital Busan Korea, Republic of 612-896
    107 Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 41404
    108 Keimyung University Dongsan Hospital Daegu Korea, Republic of 42601
    109 National Cancer Center Goyang-si Korea, Republic of 10408
    110 Chonnam National University Hospital Gwangju Korea, Republic of 61469
    111 Seoul National University Hospital Seoul Korea, Republic of 03080
    112 Severance Hospital Seoul Korea, Republic of 03722
    113 Gangnam Severance Hospital Seoul Korea, Republic of 06273
    114 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    115 Pusan National University Yangsan Hospital Yangsan-si Korea, Republic of 50612
    116 Noordwest Ziekenhuisgroep Alkmaar Netherlands 1800 AM
    117 NKI-AVL, Amsterdam Amsterdam Netherlands 1066 CX
    118 Catharina Ziekenhuis Eindhoven Netherlands 5623EJ
    119 Canisius-Wilhelmina Ziekenhuis Nijmegen Netherlands 6532SZ
    120 The Julius Center - Utrecht Science Park - Stratenum Utrecht Netherlands 3508 GA
    121 Hospital Garcia de Orta Almada Portugal 2805-267
    122 Chbv - Hosp. Infante D. Pedro Aveiro Portugal 3810-193
    123 Hosp. Sra. Da Oliveira - Guimaraes Guimarães Portugal 4835-044
    124 Centro Hospitalar de Lisboa Central Lisboa Portugal 1150-199
    125 Fundação Champalimaud Lisbon Portugal 1400-038
    126 Fundação Champalimaud Lisbon Portugal 1400-038
    127 Hospital Beatriz Angelo Loures Portugal 2674-514
    128 Instituto Portugues de Oncologia do Porto Francisco Gentil Porto Portugal 4200-072
    129 Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. Vila Nova de Gaia Portugal 4434-502
    130 Centro Hospitalar de Trás os Montes e Alto-Douro Vila Real Portugal 5000508
    131 N. N. Blokhin Russian Academy of Medical Sciences Moscow Russian Federation 115478
    132 Hertzen Oncology Research Institute Moscow Russian Federation 125284
    133 City Clinical Hospital #1 Nizhny Novgorod Russian Federation 603109
    134 Avicenna Medical Center Novosibirsk Russian Federation 630099
    135 A. Tsyb Medical Radiological Research Center Obninsk Russian Federation 249031
    136 BHI of Omsk region Clinical Oncology Dispensary Omsk Russian Federation 644013
    137 Ultrasound Clinic 4D Pyatigorsk Russian Federation 357502
    138 Hospital for War Veterans Rostov-on-Don Russian Federation 344037
    139 City Multiple-Discipline Hospital # 2 Saint Petersburg Russian Federation 192174
    140 FSBHI RSCRST n.a. Ac. Granov A.M. of MoH Saint Petersburg Russian Federation 197758
    141 City Pokrovskaya Hospital Sankt-Peterburg Russian Federation 199106
    142 Saratov State Medical University Saratov Russian Federation 410054
    143 Multifunctional clinical medical center 'Medical city' Tyumen Russian Federation 625041
    144 Bashkir State Medical University Ufa Russian Federation 450008
    145 Hosp. Univ. A Coruña A Coruña Spain 15006
    146 Hosp. Univ. Germans Trias I Pujol Badalona Spain 08916
    147 Fundacion Puigvert Barcelona Spain 08025
    148 Hosp. Clinic I Provincial de Barcelona Barcelona Spain 08036
    149 Hosp. Puerta Del Mar Cadiz Spain 11009
    150 Hosp. Univ. Virgen de Las Nieves Granada Spain 18014
    151 Hosp. de Jerez de La Frontera Jerez De La Frontera Spain 11407
    152 Hosp. Univ. Ramon Y Cajal Madrid Spain 28034
    153 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    154 Hosp. Univ. La Paz Madrid Spain 28046
    155 Hosp. Univ. Hm Monteprincipe Madrid Spain 28660
    156 Hosp. Virgen de La Victoria Málaga Spain 29010
    157 Corporacio Sanitari Parc Tauli Sabadell Spain 08208
    158 Instituto Valenciano de Oncologia Valencia Spain 46009
    159 Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital Ankara Turkey 06050
    160 Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Ankara Turkey 06590
    161 Trakya University Medical Faculty Edirne Turkey 22130
    162 Istanbul Medeniyet University Goztepe Training and Research Hospital Istanbul Turkey 34732
    163 Office Of Ahmet Cag Cal, MD Izmir Turkey 35110
    164 Izmir Medical Park Hospital Izmir Turkey 35530
    165 Inonu University Medical Faculty Malatya Turkey 44000
    166 Cherkassy Regional Oncology Dispensary, Department of Hematology Cherkasy Ukraine 18009
    167 Chernihivskyi oblasnyi onkolohichnyi dyspanser Chernihiv Ukraine 14029
    168 Chernivtsi Regional Clinical Hospital Chernivtsi Ukraine 58000
    169 SE Dnipropetrovsk Medical Academy Dnipro Ukraine 49005
    170 Main Military Clinical Hospital of MDU Kiev Ukraine 01133
    171 Asklepion LLC Kiev Ukraine 08173
    172 Kyiv City Clinical Hospital #3 Kyiv Ukraine 02660
    173 State Institution Academy Of Medical Sciences Of Ukraine Kyiv Ukraine 04053
    174 Lviv Regional Clinical Hospital Lviv Ukraine 79000
    175 Odeska miska klinichna likarnya No10 Odessa Ukraine 65000
    176 Sumy Regional Clinical Oncology Centre Sumy Ukraine 40022
    177 NHS Greater Glasgow and Clyde Glasgow United Kingdom G12 0YN
    178 East and North Hertfordshire NHS Trust Hertfordshire United Kingdom SG1 4AB
    179 Leeds Teaching Hospitals NHS Trust Leeds United Kingdom LS9 7TF
    180 Guys' and St Thomas' NHS Trust London United Kingdom SE1 9RT
    181 The Christie Nhs Foundation Trust Manchester United Kingdom M20 4BX
    182 Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom OX3 7LE
    183 Sheffield Teaching Hospitals NHS Foundation Trust Sheffield United Kingdom S10 2 JF
    184 The Clatterbridge Cancer Centre Wirral United Kingdom CH63 4JY

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04640623
    Other Study ID Numbers:
    • CR108921
    • 2020-002646-16
    • 17000139BLC2001
    First Posted:
    Nov 23, 2020
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of Aug 12, 2022