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.
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.
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
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There are 85 Locations for this study
Birmingham Alabama, 35294, United States
Tucson Arizona, 85741, United States
Little Rock Arkansas, 72205, United States
Little Rock Arkansas, 72211, United States
Duarte California, 91010, United States
San Diego California, 92123, United States
Golden Colorado, 80401, United States
Jacksonville Florida, 32209, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33176, United States
Jeffersonville Indiana, 47130, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02115, United States
Troy Michigan, 48084, United States
Rochester Minnesota, 55905, United States
Columbia Missouri, 65201, United States
Saint Louis Missouri, 63141, United States
Astoria New York, 11102, United States
Bronx New York, 10467, United States
Syracuse New York, 13202, United States
Winston-Salem North Carolina, 27103, United States
Columbus Ohio, 43210, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Pittsburgh Pennsylvania, 15232, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37209, United States
Houston Texas, 77027, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98195, United States
Brugge , 8000, Belgium
Brugge , 8310, Belgium
Genk , 3600, Belgium
Haine-saint-paul, LA Louviere , 7100, Belgium
Merksem , 2170, Belgium
Mons , 7000, Belgium
Bordeaux , 33000, France
Brest , 29200, France
Creteil , 94000, France
Lille , 59000, France
Limoges , 87000, France
Marseille , 13005, France
Montpellier , 34295, France
Nimes , 30029, France
Paris Cedex 18 , 75877, France
Paris , 75015, France
Pierre Bénite , 69495, France
Quint-Fonsegrives , 31130, France
Toulon , 83041, France
Toulouse , 31076, France
Haifa , 31096, Israel
Haifa , 34362, Israel
Jerusalem , 91120, Israel
Petah Tikva , 49372, Israel
Ramat Gan , 52621, Israel
Tel Aviv-Yafo , 64239, Israel
Avellino , 83100, Italy
Carpi , 41012, Italy
Genova , 16100, Italy
Milano , 20132, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Pisa , 56126, Italy
Pozzuoli , 80078, Italy
Roma , 00144, Italy
Torino , 10126, Italy
Busan , 612-0, Korea, Republic of
Daegu , 41404, Korea, Republic of
Daegu , 42601, Korea, Republic of
Gangnam-gu , 06351, Korea, Republic of
Goyang-Si , 10408, Korea, Republic of
Gyeongsangnam-do , 50612, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06591, Korea, Republic of
Barcelona , 08041, Spain
Granada , 18016, Spain
Madrid , 28027, Spain
Madrid , 28041, Spain
Málaga , 29010, Spain
Santander , 39002, Spain
London , EC1A , United Kingdom
Preston , PR2 9, United Kingdom
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