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Active (not recruiting) Phase 3 NCT04658862

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

Phase 3 – large-scale trial before approval
Conditions: Urinary Bladder Neoplasms

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.
Who can participate
Inclusion Criteria: * Ineligible for or have elected not to undergo radical cystectomy * All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than (\<) 2 prior to randomization * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 * Thyroid function tests are within the normal range per investigator assessment (or stable on hormone supplementation). Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal test results * Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (\>=) 1,500/cubic millimeters (mm\^3); Platelet count \>=80,000/mm\^3; Hemoglobin \>=9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (\<=) 1.5 \* upper limit of normal (ULN) or direct bilirubin \<= ULN for participants with total bilirubin levels greater than (\>)1.5\*ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (\<=) 2.5\* institutional ULN); Renal function: Creatinine clearance \>=30 mL/min using the Cockcroft-Gault formula. 24-hour creatinine clearance test will also be accepted for estimating renal function in situations where Cockcroft-Gault formula is not a good predictor of estimating adequate renal function Exclusion Criteria: * Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study * Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT * Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local 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 * Evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has healed prior to randomization
Locations 23
Argentina (1)
Fundacion Intecnus
Bariloche
Australia (1)
Flinders Medical Centre
Bedford Park
Belgium (1)
Hopital Erasme
Anderlecht
Brazil (1)
Fundacao Pio XII
Barretos
Canada (1)
McGill University Health Centre
Montreal , Quebec
China (1)
Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
Beijing
Czech Republic (1)
Slezska nemocnice v Opave
Opava
France (1)
Hopital Pellegrin CHU Bordeaux
Bordeaux
Germany (1)
Klinikum Augsburg
Augsburg
Greece (1)
Alexandra General Hospital of Athens
Athens
Hungary (1)
Eszak Pesti Centrumkorhaz Honvedkorhaz
Budapest
India (1)
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
Amravati
Italy (1)
Ospedale San Donato
Arezzo
Japan (1)
Aso Co.,Ltd Iizuka Hospital
Iizuka
Mexico (1)
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara
Poland (1)
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Siedlce
Russia (1)
Altlay Regional Oncology Dispensary
Barnaul
South Korea (1)
Inje University Haeundae Paik Hospital
Busan
Spain (1)
Hosp Univ A Coruna
A Coruña
Taiwan (1)
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City
Turkey (1)
Adana Baskent Yuregir Hospital
Adana
Ukraine (1)
Chernihivskyi oblasnyi onkolohichnyi dyspanser
Chernihiv
United States (1)
Loma Linda Univ Faculty Medic
Loma Linda , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.12.2020
Completion date
31.12.2028
Registry ID
NCT04658862
Source
anzctr
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