Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05714202
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-01-27
Brief Title:
A Study 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
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SunRISe-3
Brief 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
Detailed Description:
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-200gemcitabine 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004506-64 | EUDRACT_NUMBER | None | None |
| 17000139BLC3002 | OTHER | Janssen Research Development LLC | None |