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BRIEF TITLE: 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-Guerin (BCG) 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-Guerin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy


  • Org Study ID: CR108921
  • Secondary ID: 2020-002646-16,17000139BLC2001
  • NCT ID: NCT04640623
  • NCT Alias:
  • Sponsor: Janssen Research & Development, LLC - Industry
  • Source: 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 malignancy worldwide. The natural history of
high-risk Non-Muscle Invasive Bladder Cancer (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 TAR-200/gemcitabine (JNJ-17000139-AAC) product
(hereafter, TAR-200) is an intravesical drug delivery system regulated as an investigational
drug. The drug constituent consists of gemcitabine minitablets, and osmotic minitablets
containing urea as the osmotic agent. Cetrelimab (JNJ-63723283) is a fully human
immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds PD-1. This study consists
3 periods: screening phase (up to 30 days); treatment phase (up to 2 years); follow up phase
(up to 5 years). Total duration of study is up to 5 years. Efficacy, safety, pharmacokinetics
(PK), and biomarkers will be assessed at specified time points during this study.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: Up to 5 years

Condition:

  • Urinary Bladder Neoplasms

Eligibility

Criteria:
Inclusion Criteria:

- Histologically confirmed diagnosis of high-risk, non-muscle invasive urothelial
carcinoma in situ (CIS; Tis), with or without papillary disease (T1, high-grade Ta)
within 12 months of completion of adequate Bacillus Calmette-Guerin (BCG) therapy.
Mixed histology tumours 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)

- Visible papillary disease must be fully resected (absent) prior to randomization
(residual CIS acceptable) and documented 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 doses of an induction course (adequate induction) plus 2 of 3
doses of a maintenance course, or 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

- Concurrent extra-vesical (that is, urethra, ureter, or renal pelvis) non-muscle
invasive transitional cell carcinoma of the urothelium

- 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

- Known active hepatitis B or C infection (for example, participants with history of
hepatitis C infection but normal hepatitis C virus polymerase chain reaction test and
participants with hepatitis B with positive hepatitis B surface antigen (HBsAg)
antibody 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
Show More

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: Study Contact

Phone: 844-434-4210

Email: JNJ.CT@sylogent.com

Link: To learn how to participate in this trial please click here.

Locations

Facility Status Contact
Bladder Cancer Genitourinary Oncology
Phoenix, Arizona 85032
United States
Withdrawn
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona 85715
United States
Not yet recruiting
University of Southern California
Los Angeles, California 90033
United States
Not yet recruiting
The Urology Center of Colorado
Denver, Colorado 80211
United States
Not yet recruiting
Foothills Urology - Golden Off
Golden, Colorado 80401
United States
Not yet recruiting
DuPage Medical Group
Lisle, Illinois 60532
United States
Not yet recruiting
Indiana University
Indianapolis, Indiana 46202-5116
United States
Withdrawn
Johns Hopkins Medical Institutions
Baltimore, Maryland 21287
United States
Not yet recruiting
Wayne State University
Detroit, Michigan 48202
United States
Not yet recruiting
NYU Langone Health
New York, New York 10017
United States
Not yet recruiting
University of Rochester
Rochester, New York 14627
United States
Not yet recruiting
SUNY Upstate Medical University
Syracuse, New York 13210-2375
United States
Not yet recruiting
Associated Medical Professionals
Syracuse, New York 13210
United States
Not yet recruiting
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Not yet recruiting
Oregon Urology Institute
Springfield, Oregon 97477
United States
Withdrawn
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania 19004
United States
Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Not yet recruiting
Urology Associates, PC
Nashville, Tennessee 37209
United States
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Not yet recruiting
Urology San Antonio Research
San Antonio, Texas 78229
United States
Not yet recruiting
Spokane Urology
Spokane, Washington 99202
United States
Not yet recruiting
Flinders Medical Centre
Bedford Park, 5042
Australia
Not yet recruiting
Eastern Health Research
Box Hill, 3128
Australia
Not yet recruiting
Prince Of Wales Hospital
Randwick, 2031
Australia
Not yet recruiting
Royal North Shore Hospital
St Leonards, 2065
Australia
Not yet recruiting
Macquarie University Hospital
Sydney, 2109
Australia
Not yet recruiting
Princess Alexandra Hospital
Woolloongabba, 4102
Australia
Not yet recruiting
AZ St.-Jan Brugge-Oostende AV
Brugge, 8000
Belgium
Not yet recruiting
Hopital Erasme
Brussel, 1070
Belgium
Not yet recruiting
Universitair Ziekenhuis Gent
Gent, 9000
Belgium
Not yet recruiting
Algemeen Ziekenhuis Delta
Roeselare, 8800
Belgium
Not yet recruiting
AZ Nikolaas
Sint-Niklaas, 9100
Belgium
Not yet recruiting
Exdeo Clinical Research Inc
Abbotsford, British Columbia V2S 3N5
Canada
Not yet recruiting
The Male/Female Health and Research Centre
Barrie, Ontario L4M 7G1
Canada
Not yet recruiting
Princess Margaret Hospital- UHN
Toronto, Ontario M5G 2M9
Canada
Not yet recruiting
McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
Not yet recruiting
Universite de Sherbrooke
Sherbrooke, Quebec J1H 5H3
Canada
Not yet recruiting
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, 33300
France
Not yet recruiting
CHU Grenoble
Grenoble, 38043
France
Not yet recruiting
Clinique Sainte Marguerite
Hyeres, 83400
France
Not yet recruiting
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000
France
Not yet recruiting
Hôpital Edouard Herriot
Lyon Cedex 03, 69437
France
Not yet recruiting
Institut Paoli-Calmettes
Marseille, 13273
France
Not yet recruiting
CHU Nîmes
Nimes, 30029
France
Not yet recruiting
Hôpital Universitaire Pitié-Salpêtrière
Paris Cedex 13, 75013
France
Not yet recruiting
Hopital Europeen Georges-Pompidou
Paris, 75015
France
Not yet recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020
France
Not yet recruiting
Hopital Bichat Claude Bernard
Paris, 75877
France
Not yet recruiting
CHU De Poitiers
Poitiers, 86021
France
Withdrawn
Hopital Pontchaillou
Rennes cedex 9, 35033
France
Not yet recruiting
CHP Saint Gregoire
Saint Gregoire, 35760
France
Not yet recruiting
Institut de Cancérologie Strasbourg Europe (ICANS)
Strasbourg, 67200
France
Not yet recruiting
Hopital Foch
Suresnes, 92151
France
Not yet recruiting
Urologicum Duisburg
Duisburg, 47179
Germany
Not yet recruiting
Klinikum Herne - Urologie
Herne, 44625
Germany
Not yet recruiting
Uniklinik Köln
Köln, 50937
Germany
Not yet recruiting
Urologische Partnerschaft Köln UPK
Köln, 50968
Germany
Not yet recruiting
Matthias Schulze - Germany
Markkleeberg, 04416
Germany
Not yet recruiting
Urologie Neandertal Praxis Mettmann
Mettmann, 40822
Germany
Not yet recruiting
Universitätsklinikum Münster
Münster, 48149
Germany
Not yet recruiting
Schön Klinik Nürnberg Fürth
Nürnberg, 90491
Germany
Not yet recruiting
Studienpraxis Urologie Nürtingen - Germany
Nürtingen, 72622
Germany
Not yet recruiting
Kliniken Nordoberpfalz AG/Klinikum Weiden
Weiden, 92637
Germany
Withdrawn
Urologische Praxis am Wasserturm - Germany
Würselen, 52146
Germany
Not yet recruiting
Attikon University General Hospital of Attica
Athens, 12462
Greece
Withdrawn
Metropolitan General A.E.
Holargos, 155 62
Greece
Not yet recruiting
Athens Medical Center
Maroussi, 151 25
Greece
Not yet recruiting
Bioclinic - Thessaloniki
Thessaloniki, 546 22
Greece
Not yet recruiting
General Hospital of Thessaloniki G. Gennimatas
Thessaloniki, 54635
Greece
Not yet recruiting
Euromedica General Clinic
Thessaloniki, 54645
Greece
Not yet recruiting
'Papageorgiou' General Hospital of Thessaloniki
Thessaloniki, TK 56403
Greece
Not yet recruiting
Policlinico Abano Terme
Abano Terme, 35031
Italy
Withdrawn
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70120
Italy
Not yet recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124
Italy
Not yet recruiting
Azienda Ospedaliera Universitaria Careggi
Firenze, 50135
Italy
Not yet recruiting
Ospedale San Martino
Genova, 16132
Italy
Not yet recruiting
Ospedale San Raffaele
Milan, 20132
Italy
Not yet recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Italy
Not yet recruiting
Azienda Ospedaliera Sant Andrea
Roma, 00189
Italy
Not yet recruiting
Istituto Nazionale Tumori Regina Elena
Rome, 00144
Italy
Not yet recruiting
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Torino, 10126
Italy
Not yet recruiting
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Italy
Not yet recruiting
Ospedale San Bortolo
Vicenza, 36100
Italy
Not yet recruiting
Iizuka Hospital
Iizuka, 820-8501
Japan
Not yet recruiting
St.Marianna University School of Medicine
Kanagawa, 216-8511
Japan
Not yet recruiting
Kimitsu Chuo Hospital
Kisarazu, 292-8535
Japan
Not yet recruiting
Nagasaki University Hospital
Nagasaki, 852-8501
Japan
Not yet recruiting
JOHAS Osaka Rosai Hospital
Osaka, 591-8025
Japan
Not yet recruiting
Toranomon Hospital
Tokyo, 105-8470
Japan
Not yet recruiting
Toyama University Hospital
Toyama-shi, 930-0194
Japan
Not yet recruiting
Fujita Health University Hospital
Toyoake, 470-1192
Japan
Not yet recruiting
University of Tsukuba Hospital
Tsukuba-Shi, 305-8520
Japan
Not yet recruiting
Yamaguchi University Hospital
Ube, 755-8505
Japan
Withdrawn
Yokohama City University Medical Center
Yokohama, 232-0024
Japan
Not yet recruiting
Inje University Haeundae Paik Hospital
Busan, 612-896
Korea, Republic of
Not yet recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic of
Not yet recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
Korea, Republic of
Not yet recruiting
National Cancer Center
Goyang-si, 10408
Korea, Republic of
Not yet recruiting
Chonnam National University Hospital
Gwangju, 61469
Korea, Republic of
Not yet recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Not yet recruiting
Severance Hospital
Seoul, 03722
Korea, Republic of
Not yet recruiting
Gangnam Severance Hospital
Seoul, 06273
Korea, Republic of
Not yet recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic of
Not yet recruiting
Pusan National University Yangsan Hospital
Yangsan-si, 50612
Korea, Republic of
Not yet recruiting
Noordwest Ziekenhuisgroep
Alkmaar, 1800 AM
Netherlands
Not yet recruiting
Catharina Ziekenhuis
Eindhoven, 5623EJ
Netherlands
Not yet recruiting
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532SZ
Netherlands
Not yet recruiting
The Julius Center - Utrecht Science Park - Stratenum
Utrecht, 3508 GA
Netherlands
Not yet recruiting
Hospital Garcia de Orta
Almada, 2805-267
Portugal
Not yet recruiting
Hospital da Senhora da Oliveira
Guimarães, 4835-044
Portugal
Not yet recruiting
Centro Hospitalar de Lisboa Central
Lisboa, 1150-199
Portugal
Not yet recruiting
Fundação Champalimaud
Lisbon, 1400-038
Portugal
Not yet recruiting
Hospital Beatriz Angelo
Loures, 2674-514
Portugal
Not yet recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil
Porto, 4200-072
Portugal
Not yet recruiting
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502
Portugal
Not yet recruiting
Centro Hospitalar de Trás os Montes e Alto-Douro
Vila Real, 5000508
Portugal
Not yet recruiting
N. N. Blokhin Russian Academy of Medical Sciences
Moscow, 115478
Russian Federation
Not yet recruiting
Hertzen Oncology Research Institute
Moscow, 125284
Russian Federation
Not yet recruiting
City Clinical Hospital #1
Nizhny Novgorod, 603109
Russian Federation
Not yet recruiting
Avicenna Medical Center
Novosibirsk, 630099
Russian Federation
Not yet recruiting
A. Tsyb Medical Radiological Research Center
Obninsk, 249031
Russian Federation
Not yet recruiting
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013
Russian Federation
Not yet recruiting
Ultrasound Clinic 4D
Pyatigorsk, 357502
Russian Federation
Not yet recruiting
Hospital for War Veterans
Rostov-on-Don, 344037
Russian Federation
Not yet recruiting
City Multiple-Discipline Hospital # 2
Saint Petersburg, 192174
Russian Federation
Not yet recruiting
FSBHI RSCRST n.a. Ac. Granov A.M. of MoH
Saint Petersburg, 197758
Russian Federation
Not yet recruiting
Saratov State Medical University
Saratov, 410054
Russian Federation
Not yet recruiting
Multifunctional clinical medical center 'Medical city'
Tyumen, 625041
Russian Federation
Not yet recruiting
Bashkir State Medical University
Ufa, 450008
Russian Federation
Not yet recruiting
Hosp. Univ. A Coruña
A Coruña, 15006
Spain
Not yet recruiting
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Spain
Not yet recruiting
Fundacion Puigvert
Barcelona, 08025
Spain
Not yet recruiting
Hosp. Clinic I Provincial de Barcelona
Barcelona, 08036
Spain
Not yet recruiting
Hosp. Puerta Del Mar
Cadiz, 11009
Spain
Not yet recruiting
Hosp. Univ. Virgen de Las Nieves
Granada, 18014
Spain
Not yet recruiting
Hosp. de Jerez de La Frontera
Jerez De La Frontera, 11407
Spain
Not yet recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
Spain
Not yet recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
Spain
Not yet recruiting
Hosp. Univ. La Paz
Madrid, 28046
Spain
Not yet recruiting
Hosp. Univ. Hm Monteprincipe
Madrid, 28660
Spain
Not yet recruiting
Hosp. Virgen de La Victoria
Málaga, 29010
Spain
Not yet recruiting
Corporacio Sanitari Parc Tauli
Sabadell, 08208
Spain
Not yet recruiting
Instituto Valenciano de Oncologia
Valencia, 46009
Spain
Not yet recruiting
Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
Ankara, 06050
Turkey
Not yet recruiting
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, 06590
Turkey
Not yet recruiting
Trakya University Medical Faculty
Edirne, 22130
Turkey
Not yet recruiting
Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul, 34732
Turkey
Not yet recruiting
Office Of Ahmet Cag Cal, MD
Izmir, 35110
Turkey
Not yet recruiting
Izmir Medical Park Hospital
Izmir, 35530
Turkey
Not yet recruiting
Inonu University Medical Faculty
Malatya, 44000
Turkey
Not yet recruiting
Cherkassy Regional Oncology Dispensary, Department of Hematology
Cherkasy, 18009
Ukraine
Not yet recruiting
Chernihivskyi oblasnyi onkolohichnyi dyspanser
Chernihiv, 14029
Ukraine
Not yet recruiting
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58000
Ukraine
Not yet recruiting
SE Dnipropetrovsk Medical Academy
Dnipro, 49005
Ukraine
Not yet recruiting
Main Military Clinical Hospital of MDU
Kiev, 01133
Ukraine
Not yet recruiting
Asklepion LLC
Kiev, 08173
Ukraine
Not yet recruiting
Kyiv City Clinical Hospital #3
Kyiv, 02660
Ukraine
Not yet recruiting
State Institution Academy Of Medical Sciences Of Ukraine
Kyiv, 04053
Ukraine
Not yet recruiting
Lviv Regional Clinical Hospital
Lviv, 79000
Ukraine
Not yet recruiting
Odes'ka mis'ka klinichna likarnya №10
Odessa, 65000
Ukraine
Not yet recruiting
Sumy Regional Clinical Oncology Centre
Sumy, 40022
Ukraine
Not yet recruiting
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN
United Kingdom
Not yet recruiting
East and North Hertfordshire NHS Trust
Hertfordshire, SG1 4AB
United Kingdom
Not yet recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
United Kingdom
Not yet recruiting
Guys' and St Thomas' NHS Trust
London, SE1 9RT
United Kingdom
Not yet recruiting
The Christie Nhs Foundation Trust
Manchester, M20 4BX
United Kingdom
Not yet recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
United Kingdom
Not yet recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2 JF
United Kingdom
Not yet recruiting