Phase
Condition
Bladder Cancer
Urothelial Cancer
Treatment
Cetrelimab
TAR-200
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscleinvasive bladder cancer (HR-NMIBC), (carcinoma in situ [CIS] or tumor in situ [Tis]), with or without papillary disease (T1, high-grade Ta) or papillary diseaseonly (high-grade Ta or any T1 and absence of CIS), within 12 months of completion ofthe last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who havereceived adequate BCG. Mixed histology tumors are allowed if urothelialdifferentiation (transitional cell histology) is predominant. However, the presenceof neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoidfeatures will make a participant ineligible. For participants with lamina propriainvasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle InvasiveBladder 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 atscreening must be negative or atypical (for High-Grade Urothelial Carcinoma [HGUC])
Participants must be ineligible for or have elected not to undergo radicalcystectomy
BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy definedas a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2of 3 doses of a maintenance course, or at least 2 of 6 doses of a second inductioncourse
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Exclusion
Exclusion Criteria:
Presence or history of histologically confirmed, muscle-invasive, locally advanced,nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or StageIV)
Must not have had urothelial carcinoma or histological variant at any site outsideof the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvisand ureter) is allowable if treated with complete nephroureterectomy more than 24months prior to randomization
Received a live virus vaccine within 30 days prior to the initiation of studytreatment. Inactivated (non-live or non-replicating) vaccines approved or authorizedfor emergency use (for example, COVID-19) by local health authorities are allowed
Active hepatitis B or C infection (for example, participants with history ofhepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positivehepatitis 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 Design
Connect with a study center
Flinders Medical Centre
Bedford Park, 5042
AustraliaSite Not Available
Eastern Health Research
Box Hill, 3128
AustraliaSite Not Available
Prince Of Wales Hospital
Randwick, 2031
AustraliaSite Not Available
Royal North Shore Hospital
St Leonards, 2065
AustraliaSite Not Available
Macquarie University Hospital
Sydney, 2109
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, 4102
AustraliaSite Not Available
Algemeen Ziekenhuis Sint-Jan
Assebroek, 8310
BelgiumSite Not Available
AZ St.-Jan Brugge-Oostende AV
Brugge, 8000
BelgiumSite Not Available
Hopital Erasme
Brussel, 1070
BelgiumSite Not Available
Algemeen ziekenhuis Maria Middelares
Gent, 9000
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumSite Not Available
Algemeen Ziekenhuis Delta
Roeselare, 8800
BelgiumSite Not Available
AZ Nikolaas
Sint-Niklaas, 9100
BelgiumSite Not Available
Exdeo Clinical Research Inc
Abbotsford, British Columbia V2S 3N5
CanadaSite Not Available
The Male/Female Health and Research Centre
Barrie, Ontario L4M 7G1
CanadaSite Not Available
William Osler Health System
Brampton, Ontario L6R 3J7
CanadaSite Not Available
Princess Margaret Hospital- UHN
Toronto, Ontario M5G 2M9
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Universite de Sherbrooke
Sherbrooke, Quebec J1H 5H3
CanadaSite Not Available
Hopital Pellegrin CHU Bordeaux
Bordeaux, 33076
FranceSite Not Available
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, 33300
FranceSite Not Available
Hôpital Côte de Nacre
Caen cedex 9, 14033
FranceSite Not Available
CHU Grenoble
Grenoble, 38043
FranceSite Not Available
Clinique Sainte Marguerite
Hyeres, 83400
FranceSite Not Available
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000
FranceSite Not Available
Hôpital Edouard Herriot
Lyon Cedex 03, 69437
FranceSite Not Available
Institut Paoli-Calmettes
Marseille, 13273
FranceSite Not Available
Centre de Cancerologie du Grand Montpellier
Montpellier, 34070
FranceSite Not Available
CHU Nîmes
Nimes, 30029
FranceSite Not Available
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020
FranceSite Not Available
Hopital Bichat Claude Bernard
Paris, 75877
FranceSite Not Available
Hopital Europeen Georges-Pompidou
Paris, 75015
FranceSite Not Available
Hopital Saint Louis
Paris, 75010
FranceSite Not Available
Hopital Saint-Louis
Paris, 75010
FranceCompleted
Hôpital Universitaire Pitié-Salpêtrière
Paris Cedex 13, 75013
FranceSite Not Available
CHU De Poitiers
Poitiers, 86021
FranceSite Not Available
Clinical La Croix Du Sud - Ramsay Santé
Quint-Fonsegrives, 31130
FranceSite Not Available
Hopital Pontchaillou
Rennes cedex 9, 35033
FranceSite Not Available
CHP Saint Gregoire
Saint Gregoire, 35760
FranceSite Not Available
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg, 67200
FranceActive - Recruiting
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, 67200
FranceSite Not Available
Institut de Cancérologie Strasbourg Europe (ICANS)
Strasbourg, 67200
FranceActive - Recruiting
Hopital Foch
Suresnes, 92151
FranceSite Not Available
Hopital Rangueil
Toulouse, 31059
FranceSite Not Available
Urologicum Duisburg
Duisburg, 47179
GermanySite Not Available
Klinikum Herne - Urologie
Herne, 44625
GermanySite Not Available
Urologische Partnerschaft Koln UPK
Köln, 50968
GermanySite Not Available
Urologische Partnerschaft Köln UPK
Köln, 50968
GermanyActive - Recruiting
Matthias Schulze - Germany
Markkleeberg, 04416
GermanySite Not Available
Urologie Neandertal Praxis Mettmann
Mettmann, 40822
GermanySite Not Available
Universitatsklinikum Munster
Münster, 48149
GermanySite Not Available
Universitätsklinikum Münster
Münster, 48149
GermanyActive - Recruiting
Schön Klinik Nürnberg Fürth
Nürnberg, 90491
GermanySite Not Available
Studienpraxis Urologie Nürtingen - Germany
Nürtingen, 72622
GermanySite Not Available
Kliniken Nordoberpfalz AG/Klinikum Weiden
Weiden, 92637
GermanySite Not Available
Urologische Praxis am Wasserturm - Germany
Würselen, 52146
GermanySite Not Available
Attikon University General Hospital of Attica
Athens, 12462
GreeceSite Not Available
Metropolitan General A E
Holargos, 155 62
GreeceSite Not Available
Metropolitan General A.E.
Holargos, 155 62
GreeceCompleted
Athens Medical Center
Maroussi, 151 25
GreeceSite Not Available
'Papageorgiou' General Hospital of Thessaloniki
Thessaloniki, TK 56403
GreeceActive - Recruiting
Bioclinic - Thessaloniki
Thessaloniki, 546 22
GreeceSite Not Available
Euromedica General Clinic
Thessaloniki, 54645
GreeceSite Not Available
General Hospital of Thessaloniki G. Gennimatas
Thessaloniki, 54635
GreeceSite Not Available
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, TK 56403
GreeceSite Not Available
Policlinico Abano Terme
Abano Terme, 35031
ItalySite Not Available
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Firenze, 50135
ItalySite Not Available
Ospedale San Martino
Genova, 16132
ItalySite Not Available
Ospedale San Raffaele
Milan, 20132
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
ItalySite Not Available
Azienda Ospedaliera Sant Andrea
Roma, 00189
ItalySite Not Available
Istituto Nazionale Tumori Regina Elena
Rome, 00144
ItalySite Not Available
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126
ItalySite Not Available
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Torino, 10126
ItalyActive - Recruiting
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
ItalySite Not Available
Ospedale San Bortolo
Vicenza, 36100
ItalySite Not Available
Aso Co.,Ltd Iizuka Hospital
Iizuka, 820-8501
JapanSite Not Available
St Marianna University Hospital
Kanagawa, 216 8511
JapanSite Not Available
St.Marianna University Hospital
Kanagawa, 216-8511
JapanActive - Recruiting
Nara Medical University Hospital
Kashihara-shi, 634-8522
JapanSite Not Available
Kimitsu Chuo Hospital
Kisarazu, 292-8535
JapanSite Not Available
Kimitsu Chuo Hospital
Kisarazu-shi, 292-8535
JapanSite Not Available
Nagasaki University Hospital
Nagasaki, 852-8501
JapanSite Not Available
Nagasaki University Hospital
Nagasaki-shi, 852-8501
JapanSite Not Available
JOHAS Osaka Rosai Hospital
Osaka, 591-8025
JapanSite Not Available
Toranomon Hospital
Tokyo, 105-8470
JapanSite Not Available
Toyama University Hospital
Toyama-shi, 930-0194
JapanSite Not Available
Fujita Health University Hospital
Toyoake, 470-1192
JapanSite Not Available
University of Tsukuba Hospital
Tsukuba-Shi, 305-8520
JapanSite Not Available
Yamaguchi University Hospital
Ube, 755-8505
JapanSite Not Available
Yokohama City University Medical Center
Yokohama, 232 0024
JapanSite Not Available
Inje University Haeundae Paik Hospital
Busan, 612-896
Korea, Republic ofSite Not Available
Keimyung University Dongsan Hospital
Daegu, 42601
Korea, Republic ofSite Not Available
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic ofSite Not Available
National Cancer Center
Goyang si, 10408
Korea, Republic ofSite Not Available
National Cancer Center
Goyang-si, 10408
Korea, Republic ofSite Not Available
Chonnam National University Hospital
Gwangju, 61469
Korea, Republic ofSite Not Available
Gangnam Severance Hospital
Seoul, 06273
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, 03722
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofCompleted
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofActive - Recruiting
Pusan National University Yangsan Hospital
Yangsan Si, 50612
Korea, Republic ofSite Not Available
Pusan National University Yangsan Hospital
Yangsan-si, 50612
Korea, Republic ofSite Not Available
Noordwest Ziekenhuisgroep
Alkmaar, 1800 AM
NetherlandsSite Not Available
Antoni van Leeuwenhoek
Amsterdam, 1066 CX
NetherlandsSite Not Available
NKI AVL Amsterdam
Amsterdam, 1066 CX
NetherlandsSite Not Available
NKI-AVL, Amsterdam
Amsterdam, 1066 CX
NetherlandsActive - Recruiting
Catharina Ziekenhuis
Eindhoven, 5623EJ
NetherlandsSite Not Available
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532SZ
NetherlandsSite Not Available
The Julius Center - Utrecht Science Park - Stratenum
Utrecht, 3508 GA
NetherlandsSite Not Available
Hospital Garcia de Orta
Almada, 2805-267
PortugalSite Not Available
Chbv - Hosp. Infante D. Pedro
Aveiro, 3810-193
PortugalSite Not Available
Uls Regiao Aveiro - Hosp. Infante D. Pedro
Aveiro, 3810-193
PortugalSite Not Available
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
Coimbra, 3000-075
PortugalSite Not Available
Hosp. Sra. Da Oliveira - Guimaraes
Guimarães, 4835-044
PortugalSite Not Available
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Guimarães, 4835-044
PortugalSite Not Available
Centro Hospitalar de Lisboa Central
Lisboa, 1150-199
PortugalSite Not Available
Fund. Champalimaud
Lisbon, 1400-038
PortugalSite Not Available
Fundacao Champalimaud
Lisbon, 1400-038
PortugalActive - Recruiting
Fundação Champalimaud
Lisbon, 1400-038
PortugalActive - Recruiting
Hospital Beatriz Angelo
Loures, 2674 514
PortugalSite Not Available
Uls Loures Odivelas - Hosp. Loures
Loures, 2674 514
PortugalSite Not Available
Instituto Portugues de Oncologia do Porto Francisco Gentil
Porto, 4200-072
PortugalSite Not Available
Centro Hospitalar de Vila Nova de Gaia Espinho E P E
Vila Nova de Gaia, 4434 502
PortugalSite Not Available
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502
PortugalActive - Recruiting
Centro Hospitalar de Trás os Montes e Alto-Douro
Vila Real, 5000508
PortugalSite Not Available
Hertzen Oncology Research Institute
Moscow, 125284
Russian FederationSite Not Available
City Clinical Hospital #1
Nizhny Novgorod, 603109
Russian FederationSite Not Available
Avicenna Medical Center
Novosibirsk, 630099
Russian FederationSite Not Available
A. Tsyb Medical Radiological Research Center
Obninsk, 249031
Russian FederationSite Not Available
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013
Russian FederationSite Not Available
Ultrasound Clinic 4D
Pyatigorsk, 357502
Russian FederationSite Not Available
Hospital for War Veterans
Rostov-on-Don, 344037
Russian FederationSite Not Available
City Multiple-Discipline Hospital # 2
Saint Petersburg, 192174
Russian FederationSite Not Available
City Pokrovskaya Hospital
Sankt-Peterburg, 199106
Russian FederationSite Not Available
Saratov State Medical University
Saratov, 410054
Russian FederationSite Not Available
Multifunctional clinical medical center 'Medical city'
Tyumen, 625041
Russian FederationSite Not Available
Bashkir State Medical University
Ufa, 450008
Russian FederationSite Not Available
Hosp Univ A Coruna
A Coruña, 15006
SpainSite Not Available
Hosp. Univ. A Coruna
A Coruña, 15006
SpainSite Not Available
Hosp. Univ. A Coruña
A Coruña, 15006
SpainActive - Recruiting
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
SpainSite Not Available
Fund. Puigvert
Barcelona, 08025
SpainSite Not Available
Fundacion Puigvert
Barcelona, 08025
SpainSite Not Available
Hosp. Puerta Del Mar
Cadiz, 11009
SpainSite Not Available
Hosp. Univ. Virgen de Las Nieves
Granada, 18014
SpainSite Not Available
Hosp. de Jerez de La Frontera
Jerez De La Frontera, 11407
SpainSite Not Available
Hosp. Univ. 12 De Octubre
Madrid, 28041
SpainActive - Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hosp. Univ. Hm Monteprincipe
Madrid, 28660
SpainSite Not Available
Hosp. Univ. La Paz
Madrid, 28046
SpainSite Not Available
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
SpainSite Not Available
Hosp Virgen de La Victoria
Málaga, 29010
SpainSite Not Available
Hosp. Virgen de La Victoria
Málaga, 29010
SpainActive - Recruiting
Corporacio Sanitari Parc Tauli
Sabadell, 08208
SpainSite Not Available
Instituto Valenciano de Oncologia
Valencia, 46009
SpainSite Not Available
Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital
Ankara, 06050
TurkeySite Not Available
Trakya University Medical Faculty
Edirne, 22130
TurkeySite Not Available
Istanbul Medeniyet University Goztepe Training and Research Hospital
Istanbul, 34732
TurkeySite Not Available
Office Of Ahmet Cag Cal, MD
Izmir, 35110
TurkeySite Not Available
Inonu University Medical Faculty
Malatya, 44000
TurkeySite Not Available
Cherkassy Regional Oncology Dispensary, Department of Hematology
Cherkasy, 18009
UkraineSite Not Available
Chernihivskyi oblasnyi onkolohichnyi dyspanser
Chernihiv, 14029
UkraineSite Not Available
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58000
UkraineSite Not Available
SE Dnipropetrovsk Medical Academy
Dnipro, 49005
UkraineSite Not Available
Asklepion LLC
Kiev, 08173
UkraineSite Not Available
Kyiv City Clinical Hospital #3
Kyiv, 02660
UkraineSite Not Available
Lviv Regional Clinical Hospital
Lviv, 79000
UkraineSite Not Available
Odeska miska klinichna likarnya No10
Odessa, 65000
UkraineSite Not Available
Sumy Regional Clinical Oncology Centre
Sumy, 40022
UkraineSite Not Available
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN
United KingdomSite Not Available
East and North Hertfordshire NHS Trust
Hertfordshire, SG1 4AB
United KingdomSite Not Available
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
United KingdomSite Not Available
Guys' and St Thomas' NHS Trust
London, SE1 9RT
United KingdomSite Not Available
The Christie Nhs Foundation Trust
Manchester, M20 4BX
United KingdomSite Not Available
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
United KingdomSite Not Available
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2 JF
United KingdomSite Not Available
The Clatterbridge Cancer Centre
Wirral, CH63 4JY
United KingdomSite Not Available
Bladder Cancer Genitourinary Oncology
Phoenix, Arizona 85032
United StatesSite Not Available
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona 85715
United StatesSite Not Available
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
Genesis Healthcare Partners - Genesis Research Greater Los Angeles
Sherman Oaks, California 91411
United StatesSite Not Available
The Urology Center of Colorado
Denver, Colorado 80211
United StatesSite Not Available
Foothills Urology - Golden Off
Golden, Colorado 80401
United StatesSite Not Available
DuPage Medical Group
Lisle, Illinois 60532
United StatesSite Not Available
Urology of Indiana
Greenwood, Indiana 46143
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46202-5116
United StatesSite Not Available
Wichita Urology Group
Wichita, Kansas 67226
United StatesSite Not Available
Johns Hopkins Medical Institutions
Baltimore, Maryland 21287
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109-5000
United StatesSite Not Available
Wayne State University
Detroit, Michigan 48202
United StatesSite Not Available
Michigan Institute of Urology
Troy, Michigan 48084
United StatesSite Not Available
Delaware Valley Urology, LLC.
Voorhees, New Jersey 08043
United StatesSite Not Available
NYU Langone Health
New York, New York 10017
United StatesSite Not Available
University of Rochester
Rochester, New York 14627
United StatesSite Not Available
Associated Medical Professionals
Syracuse, New York 13210
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse, New York 13210-2375
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Wake Forest Health Sciences
Winston-Salem, North Carolina 27103
United StatesSite Not Available
The Urology Group
Cincinnati, Ohio 45212
United StatesSite Not Available
Oregon Urology Institute
Springfield, Oregon 97477
United StatesSite Not Available
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania 19004
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Urology Associates, PC
Nashville, Tennessee 37209
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Urology Austin
Austin, Texas 78745
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Urology San Antonio Research
San Antonio, Texas 78229
United StatesSite Not Available
Spokane Urology
Spokane, Washington 99202
United StatesSite Not Available
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