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Brief Title: 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-Guerin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

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

INTRODUCTION

  • Org Study ID: CR108921
  • Secondary ID: 2020-002646-16, 17000139BLC2001
  • NTC ID: NCT04640623
  • Sponsor: Janssen Research & Development, LLC

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.

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.

  • Overall Status
    Recruiting
  • Start Date
    December 18, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall Complete Response (CR) Rate

Primary Outcome 1 - Timeframe: Up to 5 years

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Janssen Research & Development, LLC Clinical Trial

Phone: 844-434-4210

Email: Participate-In-This-Study@its.jnj.com

LOCATION

Facility Status Contact
Facility: Urological Associates of Southern Arizona, P.C.
Tucson, Arizona 85715
United States
Status: Recruiting Contact: N/A
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: NYU Langone Health
New York, New York 10017
United States
Status: Recruiting Contact: N/A
Facility: SUNY Upstate Medical University
Syracuse, New York 13210-2375
United States
Status: Recruiting Contact: N/A
Facility: Associated Medical Professionals
Syracuse, New York 13210
United States
Status: Recruiting Contact: N/A
Facility: Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact: N/A
Facility: The Urology Group
Cincinnati, Ohio 45212
United States
Status: Recruiting Contact: N/A
Facility: Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: N/A
Facility: Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact: N/A
Facility: Urology Associates, PC
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: N/A
Facility: Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: N/A
Facility: University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Status: Recruiting Contact: N/A
Facility: Urology San Antonio Research
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: Spokane Urology
Spokane, Washington 99202
United States
Status: Recruiting Contact: N/A
Facility: Flinders Medical Centre
Bedford Park, British Columbia 5042
Australia
Status: Recruiting Contact: N/A
Facility: Eastern Health Research
Box Hill, Ontario 3128
Australia
Status: Recruiting Contact: N/A
Facility: Macquarie University Hospital
Sydney, Quebec 2109
Australia
Status: Recruiting Contact: N/A
Facility: Algemeen Ziekenhuis Sint-Jan
Assebroek, 8310
Belgium
Status: Recruiting Contact: N/A
Facility: AZ St.-Jan Brugge-Oostende AV
Brugge, 8000
Belgium
Status: Recruiting Contact: N/A
Facility: Hopital Erasme
Brussel, 1070
Belgium
Status: Recruiting Contact: N/A
Facility: Universitair Ziekenhuis Gent
Gent, 9000
Belgium
Status: Recruiting Contact: N/A
Facility: Algemeen Ziekenhuis Delta
Roeselare, 8800
Belgium
Status: Recruiting Contact: N/A
Facility: AZ Nikolaas
Sint-Niklaas, 9100
Belgium
Status: Recruiting Contact: N/A
Facility: Exdeo Clinical Research Inc
Abbotsford, V2S 3N5
Canada
Status: Recruiting Contact: N/A
Facility: Princess Margaret Hospital- UHN
Toronto, M5G 2M9
Canada
Status: Recruiting Contact: N/A
Facility: McGill University Health Centre
Montreal, H4A 3J1
Canada
Status: Recruiting Contact: N/A
Facility: Universite de Sherbrooke
Sherbrooke, J1H 5H3
Canada
Status: Recruiting Contact: N/A
Facility: Polyclinique Bordeaux Nord Acquitaine
Bordeaux, 33300
France
Status: Recruiting Contact: N/A
Facility: CHU Grenoble
Grenoble, 38043
France
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, 13273
France
Status: Recruiting Contact: N/A
Facility: CHU Nîmes
Nimes, 30029
France
Status: Recruiting Contact: N/A
Facility: Hôpital Universitaire Pitié-Salpêtrière
Paris Cedex 13, 75013
France
Status: Recruiting Contact: N/A
Facility: Hopital Saint-Louis
Paris, 75010
France
Status: Recruiting Contact: N/A
Facility: Hopital Europeen Georges-Pompidou
Paris, 75015
France
Status: Recruiting Contact: N/A
Facility: Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020
France
Status: Recruiting Contact: N/A
Facility: Hopital Bichat Claude Bernard
Paris, 75877
France
Status: Recruiting Contact: N/A
Facility: Hopital Pontchaillou
Rennes cedex 9, 35033
France
Status: Recruiting Contact: N/A
Facility: CHP Saint Gregoire
Saint Gregoire, 35760
France
Status: Recruiting Contact: N/A
Facility: Institut de Cancérologie Strasbourg Europe (ICANS)
Strasbourg, 67200
France
Status: Recruiting Contact: N/A
Facility: Hopital Foch
Suresnes, 92151
France
Status: Recruiting Contact: N/A
Facility: Urologicum Duisburg
Duisburg, 47179
Germany
Status: Recruiting Contact: N/A
Facility: Klinikum Herne - Urologie
Herne, 44625
Germany
Status: Recruiting Contact: N/A
Facility: Urologische Partnerschaft Köln UPK
Köln, 50968
Germany
Status: Recruiting Contact: N/A
Facility: Matthias Schulze - Germany
Markkleeberg, 04416
Germany
Status: Recruiting Contact: N/A
Facility: Urologie Neandertal Praxis Mettmann
Mettmann, 40822
Germany
Status: Recruiting Contact: N/A
Facility: Universitätsklinikum Münster
Münster, 48149
Germany
Status: Recruiting Contact: N/A
Facility: Schön Klinik Nürnberg Fürth
Nürnberg, 90491
Germany
Status: Recruiting Contact: N/A
Facility: Studienpraxis Urologie Nürtingen - Germany
Nürtingen, 72622
Germany
Status: Recruiting Contact: N/A
Facility: Urologische Praxis am Wasserturm - Germany
Würselen, 52146
Germany
Status: Recruiting Contact: N/A
Facility: Metropolitan General A.E.
Holargos, 155 62
Greece
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: General Hospital of Thessaloniki G. Gennimatas
Thessaloniki, 54635
Greece
Status: Recruiting Contact: N/A
Facility: Euromedica General Clinic
Thessaloniki, 54645
Greece
Status: Recruiting Contact: N/A
Facility: 'Papageorgiou' General Hospital of Thessaloniki
Thessaloniki, TK 56403
Greece
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliera Universitaria Careggi
Firenze, 50135
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale San Martino
Genova, 16132
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale San Raffaele
Milan, 20132
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
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: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Torino, 10126
Italy
Status: Recruiting Contact: N/A
Facility: Ospedale di Circolo e Fondazione Macchi
Varese, 21100
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 Hospital
Kanagawa, 216-8511
Japan
Status: Recruiting Contact: N/A
Facility: Kimitsu Chuo Hospital
Kisarazu-shi, 292-8535
Japan
Status: Recruiting Contact: N/A
Facility: Nagasaki University Hospital
Nagasaki-shi, 852-8501
Japan
Status: Recruiting Contact: N/A
Facility: JOHAS Osaka Rosai Hospital
Osaka, 591-8025
Japan
Status: Recruiting Contact: N/A
Facility: Toranomon Hospital
Tokyo, 105-8470
Japan
Status: Recruiting Contact: N/A
Facility: Toyama University Hospital
Toyama-shi, 930-0194
Japan
Status: Recruiting Contact: N/A
Facility: Fujita Health University Hospital
Toyoake, 470-1192
Japan
Status: Recruiting Contact: N/A
Facility: University of Tsukuba Hospital
Tsukuba-Shi, 305-8520
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: Chonnam National University Hospital
Gwangju, 61469
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: Gangnam Severance Hospital
Seoul, 06273
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
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: NKI-AVL, Amsterdam
Amsterdam, 1066 CX
Netherlands
Status: Recruiting Contact: N/A
Facility: Catharina Ziekenhuis
Eindhoven, 5623EJ
Netherlands
Status: Recruiting Contact: N/A
Facility: Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532SZ
Netherlands
Status: Recruiting Contact: N/A
Facility: The Julius Center - Utrecht Science Park - Stratenum
Utrecht, 3508 GA
Netherlands
Status: Recruiting Contact: N/A
Facility: Hospital Garcia de Orta
Almada, 2805-267
Portugal
Status: Recruiting Contact: N/A
Facility: Chbv - Hosp. Infante D. Pedro
Aveiro, 3810-193
Portugal
Status: Recruiting Contact: N/A
Facility: Hosp. Sra. Da Oliveira - Guimaraes
Guimarães, 4835-044
Portugal
Status: Recruiting Contact: N/A
Facility: Centro Hospitalar de Lisboa Central
Lisboa, 1150-199
Portugal
Status: Recruiting Contact: N/A
Facility: Fundação Champalimaud
Lisbon, 1400-038
Portugal
Status: Recruiting Contact: N/A
Facility: Hospital Beatriz Angelo
Loures, 2674-514
Portugal
Status: Recruiting Contact: N/A
Facility: Instituto Portugues de Oncologia do Porto Francisco Gentil
Porto, 4200-072
Portugal
Status: Recruiting Contact: N/A
Facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502
Portugal
Status: Recruiting Contact: N/A
Facility: Centro Hospitalar de Trás os Montes e Alto-Douro
Vila Real, 5000508
Portugal
Status: Recruiting Contact: N/A
Facility: NHS Greater Glasgow and Clyde
Glasgow, G12 0YN
United Kingdom
Status: Recruiting Contact: N/A