Bladder Cancer Clinical Trial

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

Summary

The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

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Full Description

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.

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Eligibility Criteria

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 predominance. However, the presence of small cell or neuroendocrine variants will make a participant ineligible
Participants with no residual tumor, or intravesical tumor size of less than or equal to (<=)3 centimeter (cm) following transurethral resection of bladder tumor (TURBT) are eligible; debulking TURBT for any residual disease is encouraged but not mandated. Participants with persistent tumors greater than (>)3 cm at screening must undergo a second debulking, re-staging TURBT. Participants will be ineligible if any individual tumor is >3 cm after debulking TURBT
Deemed eligible for and willing to undergo RC by the operating urologist
Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1
Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results
All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization

Exclusion Criteria:

Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment
Participants must not have evidence of cT4b, or N1-3, or M1 disease based on central radiology staging (chest, abdomen, and pelvis must be performed using computed tomography [CT] or magnetic resonance imaging [MRI]) within 42 days prior to randomization
Presence of any bladder or urethral anatomic feature that, in the opinion of the Investigator, may prevent the safe placement, indwelling use, or removal of TAR-200
Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time
Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment
Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT04919512

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 107 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Urological Associates of Southern Arizona, P.C.
Tucson Arizona, 85741, United States
UAMS Winthrop P. Rockefeller Cancer Institute
Little Rock Arkansas, 72205, United States
Arkansas Urology
Little Rock Arkansas, 72211, United States
City of Hope
Duarte California, 91010, United States
Genesis Research
San Diego California, 92123, United States
Colorodo Urology- St. Anthony Hospital
Golden Colorado, 80401, United States
University of Florida Health Jacksonville
Jacksonville Florida, 32209, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Baptist Hospital of Miami
Miami Florida, 33176, United States
Winship Cancer Institute Emory University
Atlanta Georgia, 30322, United States
DuPage Medical Group
Lisle Illinois, 60532, United States
Urology of Indiana
Indianapolis Indiana, 46260, United States
First Urology
Jeffersonville Indiana, 47130, United States
University of Louisville - James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
University Of Maryland Medical Center
Baltimore Maryland, 21201, United States
Penn Medicine - PerelmanCenter for Advanced Medicine
Baltimore Maryland, 21218, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Michigan Institute of Urology, PC
Troy Michigan, 48084, United States
University Of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Ellis Fischel Cancer Center
Columbia Missouri, 65201, United States
Washington University School Of Medicine - Center For Advanced Medicine (CAM)
Saint Louis Missouri, 63110, United States
David C. Pratt Cancer Center
Saint Louis Missouri, 63141, United States
Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08901, United States
Mount Sinai Queens Infusion Center
Astoria New York, 11102, United States
Montefiore Medical Center
Bronx New York, 10467, United States
New York University Langone Medical Center
New York New York, 10017, United States
SUNY Upstate Medical University
Syracuse New York, 13202, United States
Associated Medical Professionals
Syracuse New York, 13210, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem North Carolina, 27103, United States
The Ohio State University
Columbus Ohio, 43210, United States
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Urology Associates
Nashville Tennessee, 37209, United States
Houston Metro Urology
Houston Texas, 77027, United States
Urology San Antonio Research
San Antonio Texas, 78229, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
University of Washington School of Medicine
Seattle Washington, 98195, United States
AZ Sint-Jan Brugge-Oostende AV
Brugge , 8000, Belgium
Algemeen Ziekenhuis Sint-Jan
Brugge , 8310, Belgium
Ziekenhuis Oost-Limburg
Genk , 3600, Belgium
Hopital de Jolimont
Haine-saint-paul, LA Louviere , 7100, Belgium
ZNA Jan Palfijn
Merksem , 2170, Belgium
Centre Interuniversitaire Ambroise Pare - Ambroise Paré
Mons , 7000, Belgium
Clinique Tivoli Ducos
Bordeaux , 33000, France
ICH Hopital A. Morvan
Brest , 29200, France
Hopital Henri Mondor
Creteil , 94000, France
Hôpital Privé Le Bois
Lille , 59000, France
Polyclinique de Limoges - Francois Chenieux
Limoges , 87000, France
Hopital de la Timone
Marseille , 13005, France
CHU Montpellier
Montpellier , 34295, France
CHU Nîmes
Nimes , 30029, France
Hopital Bichat Claude Bernard
Paris Cedex 18 , 75877, France
Hopital Europeen Georges-Pompidou
Paris , 75015, France
Hospices Civils de Lyon HCL
Pierre Bénite , 69495, France
Clinical La Croix Du Sud - Ramsay Santé
Quint-Fonsegrives , 31130, France
HIA se Sainte-Anne - Toulon
Toulon , 83041, France
Clinique Pasteur
Toulouse , 31076, France
Vivantes Klinikum Am Urban
Berlin-Kreuzberg , 10967, Germany
Staedtisches Klinikum Braunschweig
Braunschweig , 38118, Germany
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Frankfurt am Main , 60431, Germany
Universitaetsklinikum Halle Saale
Halle Saale , 06120, Germany
Marien hospital Herne
Herne , 44625, Germany
Universitatsklinikum Munster
Muenster , 48149, Germany
Rambam Health Care Campus
Haifa , 31096, Israel
Carmel Medical Center
Haifa , 34362, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Rabin Medical Center - Hasharon Hospital
Petah Tikva , 49372, Israel
The Chaim Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv Yafo , 64239, Israel
Ospedale San Giuseppe Moscati di Avellino
Avellino , 83100, Italy
Ospedale Civile Ramazzini
Carpi , 41012, Italy
SPDC Villa Scassi
Genova , 16100, Italy
IRCCS Ospedale San Raffaele
Milano , 20132, Italy
Istituto Europeo di Oncologia
Milano , 20141, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli , 80131, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa , 56126, Italy
ASL Napoli 2 Nord-SM delle Grazie Hospital
Pozzuoli , 80078, Italy
Istituto Nazionale Tumori Regina Elena
Roma , 00144, Italy
IRCCS Istituto Clinico Humanitas
Rozzano , 20089, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Inje University Haeundae Paik Hospital
Busan , 612-0, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu , 42601, Korea, Republic of
Samsung Medical Center
Gangnam Gu , 06351, Korea, Republic of
National Cancer Center
Goyang-Si , 10408, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital
Seoul , 03722, Korea, Republic of
Gangnam Severance Hospital
Seoul , 06273, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan-si , 50612, Korea, Republic of
Ziekenhuisgroep Twente
Almelo , 7600, Netherlands
Haga ziekenhuis
Den Haag , 2545 , Netherlands
Radboud Umcn
Nijmegen , 6525 , Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen , 6532S, Netherlands
Hosp. Univ. A Coruna
A Coruna , 15006, Spain
Fund. Puigvert
Barcelona , 08041, Spain
Hosp. Univ. San Cecilio
Granada , 18016, Spain
Clinica Univ. de Navarra
Madrid , 28027, Spain

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT04919512

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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