A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder (SunRISe-4)
Last Updated August 7, 2024
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CR109044
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 22 -
Sites
Sites -
Status
Recruiting
SUMMARY
Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent (%) of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant metastases. The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine minitablets and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The standard of care in MIBC includes radical cystectomy (RC) with urinary diversion and is considered the preferred treatment option for participants who are considered surgical candidates. Study consists of a Screening phase, Treatment phase and follow-up phase. The total duration of study will be up to 2 years and 6 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during this study.
CONDITIONS
- Bladder Cancer
ELIGIBILITY
Inclusion Criteria:
* Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 120 days of randomization date. Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial predomin
DETAILS
LOCATIONS
Locations in:
United States, Belgium, France, Germany, Israel, Italy, South Korea, Netherlands, Spain, United Kingdom
| Country (10) | City or Province (109) | Status |
| United States | Birmingham University of Alabama at Birmingham |
RECRUITING
|
| United States | Tucson Urological Associates of Southern Arizona, P.C. |
TERMINATED
|
| United States | Little Rock UAMS Winthrop P. Rockefeller Cancer Institute |
RECRUITING
|
| United States | Little Rock Arkansas Urology |
RECRUITING
|
| United States | Duarte City of Hope |
COMPLETED
|
| United States | San Diego Genesis Research |
RECRUITING
|
| United States | Golden Colorodo Urology- St. Anthony Hospital |
RECRUITING
|
| United States | Jacksonville University of Florida Health Jacksonville |
RECRUITING
|
| United States | Jacksonville Mayo Clinic |
RECRUITING
|
| United States | Miami Baptist Hospital of Miami |
RECRUITING
|
| United States | Atlanta Winship Cancer Institute Emory University |
RECRUITING
|
| United States | Lisle DuPage Medical Group |
RECRUITING
|
| United States | Indianapolis Urology of Indiana |
RECRUITING
|
| United States | Jeffersonville First Urology |
RECRUITING
|
| United States | Louisville University of Louisville - James Graham Brown Cancer Center |
RECRUITING
|
| United States | Baltimore University Of Maryland Medical Center |
RECRUITING
|
| United States | Baltimore Penn Medicine - PerelmanCenter for Advanced Medicine |
RECRUITING
|
| United States | Boston Brigham and Women's Hospital |
RECRUITING
|
| United States | Troy Michigan Institute of Urology, PC |
RECRUITING
|
| United States | Minneapolis University Of Minnesota |
RECRUITING
|
| United States | Rochester Mayo Clinic |
RECRUITING
|
| United States | Columbia Ellis Fischel Cancer Center |
RECRUITING
|
| United States | Saint Louis Washington University School Of Medicine - Center For Advanced Medicine (CAM) |
RECRUITING
|
| United States | Saint Louis David C. Pratt Cancer Center |
TERMINATED
|
| United States | New Brunswick Robert Wood Johnson University Hospital |
RECRUITING
|
| United States | Astoria Mount Sinai Queens Infusion Center |
RECRUITING
|
| United States | Bronx Montefiore Medical Center |
RECRUITING
|
| United States | New York New York University Langone Medical Center |
RECRUITING
|
| United States | New York Memorial Sloan Kettering Cancer Center |
RECRUITING
|
| United States | Syracuse SUNY Upstate Medical University |
RECRUITING
|
| United States | Syracuse Associated Medical Professionals |
RECRUITING
|
| United States | Winston-Salem Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center |
RECRUITING
|
| United States | Columbus The Ohio State University |
RECRUITING
|
| United States | Bala-Cynwyd MidLantic Urology |
RECRUITING
|
| United States | Pittsburgh University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center |
RECRUITING
|
| United States | Myrtle Beach Carolina Urologic Research Center |
RECRUITING
|
| United States | Nashville Urology Associates |
RECRUITING
|
| United States | Houston Houston Metro Urology |
RECRUITING
|
| United States | San Antonio Urology San Antonio Research |
RECRUITING
|
| United States | Salt Lake City Huntsman Cancer Institute |
RECRUITING
|
| United States | Seattle University of Washington School of Medicine |
RECRUITING
|
| Belgium | Brugge AZ Sint-Jan Brugge-Oostende AV |
RECRUITING
|
| Belgium | Brugge Algemeen Ziekenhuis Sint-Jan |
RECRUITING
|
| Belgium | Genk Ziekenhuis Oost-Limburg |
RECRUITING
|
| Belgium | Haine Saint Paul La Louviere Hopital de Jolimont |
RECRUITING
|
| Belgium | Merksem ZNA Jan Palfijn |
RECRUITING
|
| Belgium | Mons Centre Interuniversitaire Ambroise Pare - Ambroise Paré |
RECRUITING
|
| France | Bordeaux Clinique Tivoli Ducos |
RECRUITING
|
| France | Brest ICH Hopital A. Morvan |
RECRUITING
|
| France | Creteil Hopital Henri Mondor |
RECRUITING
|
| France | Lille Hôpital Privé Le Bois |
RECRUITING
|
| France | Limoges Polyclinique de Limoges - Francois Chenieux |
RECRUITING
|
| France | Marseille Hopital de la Timone |
RECRUITING
|
| France | Montpellier CHU Montpellier |
RECRUITING
|
| France | Nimes CHU Nîmes |
RECRUITING
|
| France | Paris Cedex 18 Hopital Bichat Claude Bernard |
RECRUITING
|
| France | Paris Hopital Europeen Georges-Pompidou |
RECRUITING
|
| France | Pierre Bénite Hospices Civils de Lyon HCL |
RECRUITING
|
| France | Quint-Fonsegrives Clinical La Croix Du Sud - Ramsay Santé |
RECRUITING
|
| France | Toulon HIA se Sainte-Anne - Toulon |
COMPLETED
|
| France | Toulouse Clinique Pasteur |
RECRUITING
|
| Germany | Berlin-Kreuzberg Vivantes Klinikum Am Urban |
RECRUITING
|
| Germany | Braunschweig Staedtisches Klinikum Braunschweig |
RECRUITING
|
| Germany | Frankfurt am Main Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus |
RECRUITING
|
| Germany | Halle Saale Universitaetsklinikum Halle Saale |
RECRUITING
|
| Germany | Herne Marien hospital Herne |
RECRUITING
|
| Germany | Muenster Universitatsklinikum Munster |
RECRUITING
|
| Israel | Haifa Rambam Health Care Campus |
RECRUITING
|
| Israel | Haifa Carmel Medical Center |
RECRUITING
|
| Israel | Jerusalem Hadassah Medical Center |
RECRUITING
|
| Israel | Petah Tikva Rabin Medical Center - Hasharon Hospital |
RECRUITING
|
| Israel | Ramat Gan The Chaim Sheba Medical Center |
RECRUITING
|
| Israel | Tel Aviv Yafo Tel Aviv Sourasky Medical Center |
RECRUITING
|
| Italy | Avellino Ospedale San Giuseppe Moscati di Avellino |
RECRUITING
|
| Italy | Carpi Ospedale Civile Ramazzini |
RECRUITING
|
| Italy | Genova SPDC Villa Scassi |
COMPLETED
|
| Italy | Milano IRCCS Ospedale San Raffaele |
RECRUITING
|
| Italy | Milano Istituto Dei Tumori Di Milano |
RECRUITING
|
| Italy | Milano Istituto Europeo di Oncologia |
RECRUITING
|
| Italy | Napoli Istituto Nazionale Tumori Fondazione G. Pascale |
RECRUITING
|
| Italy | Pisa Azienda Ospedaliero Universitaria Pisana |
RECRUITING
|
| Italy | Pozzuoli ASL Napoli 2 Nord-SM delle Grazie Hospital |
RECRUITING
|
| Italy | Roma Istituto Nazionale Tumori Regina Elena |
RECRUITING
|
| Italy | Rozzano IRCCS Istituto Clinico Humanitas |
RECRUITING
|
| Italy | Torino Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino |
RECRUITING
|
| South Korea | Busan Inje University Haeundae Paik Hospital |
RECRUITING
|
| South Korea | Daegu Kyungpook National University Chilgok Hospital |
RECRUITING
|
| South Korea | Daegu Keimyung University Dongsan Hospital |
RECRUITING
|
| South Korea | Gangnam Gu Samsung Medical Center |
RECRUITING
|
| South Korea | Goyang-Si National Cancer Center |
RECRUITING
|
| South Korea | Seoul Korea University Anam Hospital |
RECRUITING
|
| South Korea | Seoul Seoul National University Hospital |
RECRUITING
|
| South Korea | Seoul Severance Hospital |
RECRUITING
|
| South Korea | Seoul Gangnam Severance Hospital |
RECRUITING
|
| South Korea | Seoul The Catholic University of Korea Seoul St Mary s Hospital |
COMPLETED
|
| South Korea | Yangsan-si Pusan National University Yangsan Hospital |
RECRUITING
|
| Netherlands | Almelo Ziekenhuisgroep Twente |
RECRUITING
|
| Netherlands | Den Haag Haga ziekenhuis |
RECRUITING
|
| Netherlands | Nijmegen Radboud Umcn |
RECRUITING
|
| Netherlands | Nijmegen Canisius-Wilhelmina Ziekenhuis |
RECRUITING
|
| Spain | A Coruna Hosp. Univ. A Coruna |
RECRUITING
|
| Spain | Barcelona Fund. Puigvert |
RECRUITING
|
| Spain | Granada Hosp. Univ. San Cecilio |
RECRUITING
|
| Spain | Madrid Clinica Univ. de Navarra |
TERMINATED
|
| Spain | Madrid Hospital Universitario 12 de Octubre |
RECRUITING
|
| Spain | Málaga Hosp. Virgen de La Victoria |
RECRUITING
|
| Spain | Santander Hosp. Univ. Marques de Valdecilla |
RECRUITING
|
| United Kingdom | London Barts Health NHS Trust |
RECRUITING
|
| United Kingdom | Preston Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital |
RECRUITING
|
Geo Locations
33.52066, -86.80249
32.22174, -110.92648
34.74648, -92.28959
34.74648, -92.28959
34.13945, -117.97729
32.71533, -117.15726
39.75554, -105.2211
30.33218, -81.65565
30.33218, -81.65565
25.77427, -80.19366
33.749, -84.38798
41.80114, -88.07479
39.76838, -86.15804
38.27757, -85.73718
38.25424, -85.75941
39.29038, -76.61219
39.29038, -76.61219
42.35843, -71.05977
42.60559, -83.14993
44.97997, -93.26384
44.02163, -92.4699
38.95171, -92.33407
38.62727, -90.19789
38.62727, -90.19789
40.48622, -74.45182
40.77205, -73.93014
40.84985, -73.86641
40.71427, -74.00597
40.71427, -74.00597
43.04812, -76.14742
43.04812, -76.14742
36.09986, -80.24422
39.96118, -82.99879
40.00761, -75.23407
40.44062, -79.99589
33.68906, -78.88669
36.16589, -86.78444
29.76328, -95.36327
29.42412, -98.49363
40.76078, -111.89105
47.60621, -122.33207
51.20892, 3.22424
51.20892, 3.22424
50.965, 5.50082
50.45313, 4.19126
51.24623, 4.44903
50.45413, 3.95229
44.84044, -0.5805
48.3903, -4.48628
48.78333, 2.46667
50.63297, 3.05858
45.83153, 1.25781
43.29551, 5.38958
43.61092, 3.87723
43.83333, 4.35
48.85341, 2.3488
48.85341, 2.3488
45.7009, 4.82511
43.5852, 1.5272
43.12442, 5.92836
43.60426, 1.44367
52.49973, 13.40338
52.26594, 10.52673
50.11552, 8.68417
51.48159, 11.97948
51.5388, 7.22572
51.96236, 7.62571
32.81841, 34.9885
32.81841, 34.9885
31.76904, 35.21633
32.08707, 34.88747
32.08227, 34.81065
32.08088, 34.78057
40.91494, 14.79103
44.78237, 10.8777
44.40478, 8.94438
45.46427, 9.18951
45.46427, 9.18951
45.46427, 9.18951
40.85216, 14.26811
43.70853, 10.4036
40.84394, 14.0952
41.89193, 12.51133
45.38193, 9.1559
45.07049, 7.68682
35.10278, 129.04028
35.87028, 128.59111
35.87028, 128.59111
37.4872029, 127.0847467
37.65639, 126.835
37.566, 126.9784
37.566, 126.9784
37.566, 126.9784
37.566, 126.9784
37.566, 126.9784
35.3251513, 129.0068369
52.35667, 6.6625
52.07667, 4.29861
51.8425, 5.85278
51.8425, 5.85278
43.37135, -8.396
41.38879, 2.15899
37.18817, -3.60667
40.4165, -3.70256
40.4165, -3.70256
36.72016, -4.42034
43.46472, -3.80444
51.50853, -0.12574
53.76282, -2.70452
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