A phase 3, open-label, multi-center, randomized study evaluating the efficacy and
safety of tar-200 in combination with cetrelimab or tar-200 alone versus intravesical
bacillus calmette-guérin (bcg) in participants with bcg-naïve high-risk non-muscle
invasive bladder cancer (hr-nmibc)
Source : Translated by artificial intelligence
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Une étude randomisée de phase 3, ouverte, multicentrique, évaluant l'efficacité et la sécurité de TAR-200 en association avec le Cetrelimab ou TAR-200 seul par rapport au Bacille de Calmette et Guérin (BCG) intravésical chez les participants atteints d'un cancer de la vessie non invasif à haut risque (HR-NMIBC) naïfs de BCG
Cancer de la vessie non-infiltrant au plan musculaire, à haut-risque (Ta, T1, CIS), BCG naif, ECOG 0, 1, ou 2
Exclusion criteria
maladie invasive ou métastatique, polyurie
Cohorts
Proposed Therapy or Intervention
Intervention
TAR-200, Cetrelimab, BCG
Cohorts
Centre hospitalier Universitaire de Québec
Data not available
Current data since :
April 26, 2024 00:19
Centre intégré de santé et de services sociaux des Laurentides
Data not available
Current data since :
May 07, 2024 00:15
Centre hospitalier de l'Université de Montréal
Data not available
Current data since :
April 22, 2024 17:16
other centers
Name
Medical condition
Treatment
Recruitment status
Treatment Group A: TAR-200 + Cetrelimab
Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.
Data not available
Unknown
Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture
Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).
Data not available
Unknown
Treatment Group C: TAR-200 Alone
Participants will receive intravesical TAR-200 alone once Q3W.
Data not available
Unknown
Treatment Group A: TAR-200 + Cetrelimab
Recruitment status
unknown
Participants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.
Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture
Recruitment status
unknown
Participants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).
Treatment Group C: TAR-200 Alone
Recruitment status
unknown
Participants will receive intravesical TAR-200 alone once Q3W.
Current data since :
April 23, 2024 20:00
Study's description
Study description
Study summary
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine 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 mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG. The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total duration of the study will be up to 5 years and 2 months. Efficacy, Safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the study.
Locations
Locations
Main center
CENTRE HOSPITALIER UNIVERSITAIRE DE QUÉBEC
Québec
QUÉBEC, CANADA
Local recruitment
Recruiting status:
UPCOMING
Participating centers
10
shown
out of
235
centers
CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL
Montréal
QUÉBEC, CANADA
Local recruitment
Recruiting status:
POSSIBLY OPEN
Contact details for recruitment
Data not available
Local project contacts
researchers:
J. Lattouf
co-researchers:
F. Saad
Z. Hamilou
CENTRE INTÉGRÉ DE SANTÉ ET DE SERVICES SOCIAUX DES LAURENTIDES
