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
NCT ID: NCT04640623
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2020-12-18
2027-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: TAR-200 and Cetrelimab
TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, 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).
TAR-200
TAR-200 will be administered transuretherally.
Cetrelimab
Cetrelimab will be administered.
Cohort 2: TAR-200
TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, 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).
TAR-200
TAR-200 will be administered transuretherally.
Cohort 3: Cetrelimab
Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).
Cetrelimab
Cetrelimab will be administered.
Cohort 4: TAR-200 (Participants with Papillary Disease only)
TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, 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).
TAR-200
TAR-200 will be administered transuretherally.
Interventions
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TAR-200
TAR-200 will be administered transuretherally.
Cetrelimab
Cetrelimab will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 at screening must be negative or atypical (for High-Grade Urothelial Carcinoma \[HGUC\])
* 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
* 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
* Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Genesis Healthcare Partners - Genesis Research Greater Los Angeles
Sherman Oaks, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Foothills Urology - Golden Off
Golden, Colorado, United States
DuPage Medical Group
Lisle, Illinois, United States
Urology of Indiana
Greenwood, Indiana, United States
Wichita Urology Group
Wichita, Kansas, United States
Michigan Institute of Urology
Troy, Michigan, United States
NYU Langone Health
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Associated Medical Professionals
Syracuse, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Urology Associates, PC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Urology Austin
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Spokane Urology
Spokane, Washington, United States
Flinders Medical Centre
Bedford Park, , Australia
Eastern Health Research
Box Hill, , Australia
Macquarie University Hospital
Sydney, , Australia
Algemeen Ziekenhuis Sint-Jan
Assebroek, , Belgium
AZ St.-Jan Brugge-Oostende AV
Bruges, , Belgium
Hopital Erasme
Brussels, , Belgium
Algemeen ziekenhuis Maria Middelares
Ghent, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Algemeen Ziekenhuis Delta
Roeselare, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
Exdeo Clinical Research Inc
Abbotsford, British Columbia, Canada
William Osler Health System
Brampton, Ontario, Canada
Princess Margaret Hospital- UHN
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Universite de Sherbrooke
Sherbrooke, Quebec, Canada
Hopital Pellegrin CHU Bordeaux
Bordeaux, , France
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, , France
CHU Grenoble
Grenoble, , France
Clinique Sainte Marguerite
Hyères, , France
Polyclinique de Limoges - Francois Chenieux
Limoges, , France
Hôpital Edouard Herriot
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
Centre de Cancerologie du Grand Montpellier
Montpellier, , France
CHU Nimes
Nîmes, , France
Hopital Saint Louis
Paris, , France
Hôpital Universitaire Pitié-Salpêtrière
Paris, , France
Hopital Europeen Georges-Pompidou
Paris, , France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, , France
Hopital Bichat Claude Bernard
Paris, , France
Clinical La Croix Du Sud - Ramsay Santé
Quint-Fonsegrives, , France
Hopital Pontchaillou
Rennes, , France
CHP Saint Gregoire
Saint-Grégoire, , France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, , France
Hopital Foch
Suresnes, , France
Hopital Rangueil
Toulouse, , France
Urologische Partnerschaft Koln UPK
Cologne, , Germany
Urologicum Duisburg
Duisburg, , Germany
Klinikum Herne - Urologie
Herne, , Germany
Matthias Schulze - Germany
Markkleeberg, , Germany
Urologie Neandertal Praxis Mettmann
Mettmann, , Germany
Universitatsklinikum Munster
Münster, , Germany
Schön Klinik Nürnberg Fürth
Nuremberg, , Germany
Studienpraxis Urologie Nürtingen - Germany
Nürtingen, , Germany
Urologische Praxis am Wasserturm - Germany
Würselen, , Germany
Metropolitan General A E
Cholargós, , Greece
Athens Medical Center
Marousi, , Greece
Bioclinic - Thessaloniki
Thessaloniki, , Greece
General Hospital of Thessaloniki G. Gennimatas
Thessaloniki, , Greece
Euromedica General Clinic
Thessaloniki, , Greece
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, , Greece
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, , Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Ospedale San Martino
Genova, , Italy
Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Azienda Ospedaliera Sant Andrea
Roma, , Italy
Istituto Nazionale Tumori Regina Elena
Rome, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Ospedale San Bortolo
Vicenza, , Italy
Aso Co.,Ltd Iizuka Hospital
Iizuka, , Japan
St Marianna University Hospital
Kanagawa, , Japan
Nara Medical University Hospital
Kashihara-shi, , Japan
Kimitsu Chuo Hospital
Kisarazu-shi, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
JOHAS Osaka Rosai Hospital
Osaka, , Japan
Toranomon Hospital
Tokyo, , Japan
Toyama University Hospital
Toyama, , Japan
Fujita Health University Hospital
Toyoake, , Japan
University of Tsukuba Hospital
Tsukuba, , Japan
Yokohama City University Medical Center
Yokohama, , Japan
Antoni van Leeuwenhoek
Amsterdam, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
The Julius Center - Utrecht Science Park - Stratenum
Utrecht, , Netherlands
Hospital Garcia de Orta
Almada, , Portugal
Uls Regiao Aveiro - Hosp. Infante D. Pedro
Aveiro, , Portugal
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Guimarães, , Portugal
Centro Hospitalar de Lisboa Central
Lisbon, , Portugal
Fund. Champalimaud
Lisbon, , Portugal
Uls Loures Odivelas - Hosp. Loures
Loures, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil
Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia Espinho E P E
Vila Nova de Gaia, , Portugal
Centro Hospitalar de Trás os Montes e Alto-Douro
Vila Real, , Portugal
Hertzen Oncology Research Institute
Moscow, , Russia
Privolzhsky District Medical Centre
Nizhny Novgorod, , Russia
Avicenna Medical Center
Novosibirsk, , Russia
A. Tsyb Medical Radiological Research Center
Obninsk, , Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, , Russia
Ultrasound Clinic 4D
Pyatigorsk, , Russia
Saratov State Medical University
Saratov, , Russia
Multifunctional clinical medical center 'Medical city'
Tyumen, , Russia
Bashkir State Medical University
Ufa, , Russia
Inje University Haeundae Paik Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
National Cancer Center
Goyang-si, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Hosp Univ A Coruna
A Coruña, , Spain
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Fund. Puigvert
Barcelona, , Spain
Hosp. Puerta Del Mar
Cadiz, , Spain
Hosp. Univ. Virgen de Las Nieves
Granada, , Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Univ. La Paz
Madrid, , Spain
Hosp. Univ. Hm Monteprincipe
Madrid, , Spain
Hosp Virgen de La Victoria
Málaga, , Spain
Corporacio Sanitari Parc Tauli
Sabadell, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
Chernihivskyi oblasnyi onkolohichnyi dyspanser
Chernihiv, , Ukraine
Asklepion LLC
Kiev, , Ukraine
Sumy Regional Clinical Oncology Centre
Sumy, , Ukraine
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Countries
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References
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Daneshmand S, Van der Heijden MS, Jacob JM, Guerrero-Ramos F, Bogemann M, Simone G, Pieczonka CM, Casco NC, Zainfeld D, Spiegelhalder P, Xylinas E, Cahn D, Lotan Y, Murray KS, Kawahara T, Stromberg K, Martin J, Shukla A, Cutie CJ, Bertzos K, Hampras S, Sweiti H, Necchi A; SunRISe-1 Study. TAR-200 for Bacillus Calmette-Guerin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. J Clin Oncol. 2025 Jul 30:JCO2501651. doi: 10.1200/JCO-25-01651. Online ahead of print.
Other Identifiers
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17000139BLC2001
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002646-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506146-23-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108921
Identifier Type: -
Identifier Source: org_study_id