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Brief Title: A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

INTRODUCTION

  • Org Study ID: CR108917
  • Secondary ID: 2020-002620-36, 17000139BLC3001
  • NTC ID: NCT04658862
  • Sponsor: Janssen Research & Development, LLC
To learn how to participate in this trial please click here.

BRIEF SUMMARY

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy.

DETAILED DESCRIPTION

The TAR-200 is an investigational drug delivery system. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed cell death protein 1 (PD-1). Study consists of screening phase of 42 days, treatment phase and follow up phase. The total duration of study will be up to 8 years. Efficacy evaluation includes disease assessment (Cystoscopy/TURBT Biopsy/Pathology) and Patient Reported Outcomes (Quality of Life Assessments) and safety assessments includes vital sign measurements, 12-lead electrocardiogram (ECG), physical examinations, clinical laboratory tests, cystoscopic examination, anti-drug antibody (ADA) assessments, concomitant treatments/procedures and adverse event monitoring.

  • Overall Status
    Recruiting
  • Start Date
    December 7, 2020
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event

Primary Outcome 1 - Timeframe: Up to 8 years

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

Inclusion Criteria:
Ineligible for or have elected not to undergo radical cystectomy

- All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization - Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 - Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. - Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (>=) 1,500/cubic millimeters (mm^3); Platelet count >=80,000/mm^3; Hemoglobin >=9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (<=) 1.5 * upper limit of normal (ULN) or direct bilirubin <= ULN for participants with total bilirubin levels greater than (>)1.5*ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (<=) 2.5* institutional ULN); Renal function: Creatinine clearance >40 mL/min using the Cockcroft-Gault formula
Exclusion Criteria:
Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephrouretrectomy more than 24 months prior to initiating study

- Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT

- Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to randomization

- Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 200

- Evidence of bladder perforation during diagnostic cystoscopy

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trials

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Janssen Research & Development, LLC Clinical Trials

Phone: 844-434-4210

Email: JNJ.CT@sylogent.com

LOCATION

Facility Status Contact
Facility: University of Southern California
Los Angeles, California 90033
United States
Status: Recruiting Contact: N/A
Facility: The Urology Center of Colorado
Denver, Colorado 80211
United States
Status: Recruiting Contact: N/A
Facility: Foothills Urology - Golden Off
Golden, Colorado 80401
United States
Status: Recruiting Contact: N/A
Facility: DuPage Medical Group
Lisle, Illinois 60532
United States
Status: Recruiting Contact: N/A
Facility: New Jersey Urology Nju
Voorhees, New Jersey 08043
United States
Status: Recruiting Contact: N/A
Facility: MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: N/A
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: N/A
Facility: University of Texas Medical Branch
League City, Texas 77573
United States
Status: Recruiting Contact: N/A
Facility: Flinders Medical Centre
Bedford Park, 5042
Australia
Status: Recruiting Contact: N/A
Facility: Krankenhaus der barmherzigen Schwestern
Linz, 4010
Austria
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Salzburg - Landeskrankenhaus
Salzburg, 5020
Austria
Status: Recruiting Contact: N/A
Facility: Hopital Erasme
Anderlecht, 1070
Belgium
Status: Recruiting Contact: N/A
Facility: AZ Sint-Lucas
Assebroek, 8310
Belgium
Status: Recruiting Contact: N/A
Facility: AZ Sint-Jan Brugge-Oostende AV
Brugge, 8000
Belgium
Status: Recruiting Contact: N/A
Facility: Az Groeninge
Kortrijk, 8500
Belgium
Status: Recruiting Contact: N/A
Facility: Slezska nemocnice v Opave
Opava, 746 01
Czechia
Status: Recruiting Contact: N/A
Facility: Thomayerova nemocnice
Praha 4, 140 59
Czechia
Status: Recruiting Contact: N/A
Facility: Clinique Sainte Marguerite
Hyeres, 83400
France
Status: Recruiting Contact: N/A
Facility: Polyclinique de Limoges - Francois Chenieux
Limoges, 87000
France
Status: Recruiting Contact: N/A
Facility: Hôpital Edouard Herriot
Lyon Cedex 03, 69437
France
Status: Recruiting Contact: N/A
Facility: Institut Paoli-Calmettes
Marseille, 13009
France
Status: Recruiting Contact: N/A
Facility: Institut Regional du Cancer de Montpellier
Montpellier, 34298
France
Status: Recruiting Contact: N/A
Facility: CHU Nîmes
Nimes, 30029
France
Status: Recruiting Contact: N/A
Facility: Hopital Europeen Georges-Pompidou
Paris, 75015
France
Status: Recruiting Contact: N/A
Facility: Hôpital Bichat - Claude Bernard
Paris, 75018
France
Status: Recruiting Contact: N/A
Facility: Centre Hospitalier Prive
Saint-Grégoire, 35760
France
Status: Recruiting Contact: N/A
Facility: Klinikum Herne - Urologie
Herne, 44625
Germany
Status: Recruiting Contact: N/A
Facility: Athens Medical Center
Maroussi, 151 25
Greece
Status: Recruiting Contact: N/A
Facility: Bioclinic - Thessaloniki
Thessaloniki, 546 22
Greece
Status: Recruiting Contact: N/A
Facility: Anassa General Clinic
Volos, 38333
Greece
Status: Recruiting Contact: N/A
Facility: Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Hungary
Status: Recruiting Contact: N/A
Facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400
Hungary
Status: Recruiting Contact: N/A
Facility: Azienda Sanitaria Locale Salerno - Po Andrea Tortora Di Pagani
Pagani, 84016
Italy
Status: Recruiting Contact: N/A
Facility: ASL Napoli 2 Nord-SM delle Grazie Hospital
Pozzuoli, 80078
Italy
Status: Recruiting Contact: N/A
Facility: Policlinico Universitario Agostino Gemelli
Roma, 00168
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Sant Andrea
Roma, 00189
Italy
Status: Recruiting Contact: N/A
Facility: Istituto Nazionale Tumori Regina Elena
Rome, 00144
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale San Bortolo
Vicenza, 36100
Italy
Status: Recruiting Contact: N/A
Facility: Aso Co.,Ltd Iizuka Hospital
Iizuka, 820-8501
Japan
Status: Recruiting Contact: N/A
Facility: St.Marianna University School of Medicine
Kanagawa, 216-8511
Japan
Status: Recruiting Contact: N/A
Facility: Nara Medical University Hospital
Kashihara, 634-8522
Japan
Status: Recruiting Contact: N/A
Facility: Saitama Medical University Hospital
Kawagoe-Shi, 350-8550
Japan
Status: Recruiting Contact: N/A
Facility: Kimitsu Chuo Hospital
Kisarazu, 292-8535
Japan
Status: Recruiting Contact: N/A
Facility: Nagasaki University Hospital
Nagasaki, 852-8501
Japan
Status: Recruiting Contact: N/A
Facility: JOHAS Osaka Rosai Hospital
Osaka, 591-8025
Japan
Status: Recruiting Contact: N/A
Facility: Tokuyama Central Hospital
Shunan, 745-8522
Japan
Status: Recruiting Contact: N/A
Facility: Toranomon Hospital
Tokyo, 105-8470
Japan
Status: Recruiting Contact: N/A
Facility: Fujita Health University Hospital
Toyoake, 470-1192
Japan
Status: Recruiting Contact: N/A
Facility: Yamaguchi University Hospital
Ube, 755-8505
Japan
Status: Recruiting Contact: N/A
Facility: Yokohama City University Medical Center
Yokohama, 232-0024
Japan
Status: Recruiting Contact: N/A
Facility: Inje University Haeundae Paik Hospital
Busan, 612-896
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Keimyung University Dongsan Hospital
Daegu, 42601
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: National Cancer Center
Goyang-si, 10408
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Gachon University Gil Medical Center
Namdong, 405 760
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Severance Hospital
Seoul, 03722
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Pusan National University Yangsan Hospital
Yangsan-si, 50612
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Siedlce, 08-110
Poland
Status: Recruiting Contact: N/A
Facility: Centrum Medyczne Pratia Poznan
Skorzewo, 60-185
Poland
Status: Recruiting Contact: N/A
Facility: Centralny Szpital Kliniczny MSWiA w Warszawie
Warszawa, 02-507
Poland
Status: Recruiting Contact: N/A
Facility: H. Santa Maria - Centro Hospitalar de Lisboa Norte
Lisboa, 1649-035
Portugal
Status: Recruiting Contact: N/A
Facility: Altlay Regional Oncology Dispensary
Barnaul, 656045
Russian Federation
Status: Recruiting Contact: N/A
Facility: Ivanovo Regional Oncology Dispensary
Ivanovo, 153040
Russian Federation
Status: Recruiting Contact: N/A
Facility: Krasnoyarsk Regional Oncology Dispensary
Krasnoyarsk, 660133
Russian Federation
Status: Recruiting Contact: N/A
Facility: A. Tsyb Medical Radiological Research Center
Obninsk, 249031
Russian Federation
Status: Recruiting Contact: N/A
Facility: BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013
Russian Federation
Status: Recruiting Contact: N/A
Facility: Ogarev Mordovian State University
Saransk, 430005
Russian Federation
Status: Recruiting Contact: N/A
Facility: State Medical Institution Oncological Center #2 of Healthcare Department at Krasnodar Regio
Sochi, 354057
Russian Federation
Status: Recruiting Contact: N/A
Facility: Multifunctional clinical medical center 'Medical city'
Tyumen, 625041
Russian Federation
Status: Recruiting Contact: N/A
Facility: Bashkir State Medical University
Ufa, 450008
Russian Federation
Status: Recruiting Contact: N/A
Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807
Taiwan
Status: Recruiting Contact: N/A
Facility: China Medical University Hospital
Taichung, 40447
Taiwan
Status: Recruiting Contact: N/A
Facility: National Taiwan University Hospital
Taipei City, 10048
Taiwan
Status: Recruiting Contact: N/A
Facility: Tri-Service General Hospital
Taipei, 11490
Taiwan
Status: Recruiting Contact: N/A
Facility: Chang Gung Memorial Hospital Linkou Branch
Taoyuan, 333
Taiwan
Status: Recruiting Contact: N/A
Facility: Chernihivskyi oblasnyi onkolohichnyi dyspanser
Chernihiv, 58000
Ukraine
Status: Recruiting Contact: N/A
Facility: SE Dnipropetrovsk Medical Academy
Dnipro, 61037
Ukraine
Status: Recruiting Contact: N/A
Facility: Kharkiv Regional Clinical Hospital
Kharkiv, 73000
Ukraine
Status: Recruiting Contact: N/A
Facility: Khersonsky Regional Oncology Center
Kherson, 01133
Ukraine
Status: Recruiting Contact: N/A
Facility: Asklepion LLC
Kiev, 50048
Ukraine
Status: Recruiting Contact: N/A
Facility: Kyiv City Clinical Hospital #3
Kyiv, 04053
Ukraine
Status: Recruiting Contact: N/A
Facility: State Institution Academy Of Medical Sciences Of Ukraine
Kyiv, 04112
Ukraine
Status: Recruiting Contact: N/A
Facility: P.L. Shupyk National Medical Academy of Post-Graduate Education
Kyiv, 79000
Ukraine
Status: Recruiting Contact: N/A
Facility: Lviv Regional Clinical Hospital
Lviv, 65000
Ukraine
Status: Recruiting Contact: N/A