SunRISe-5
Research type
Research Study
Full title
A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator’s Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred with High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
IRAS ID
1009453
Contact name
Sarah Pickford
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2023-507685-10
Research summary
This is a Phase 3, randomised, open-label, active-controlled, multi-centre study evaluating the efficacy and safety of an investigational drug delivery system (TAR-200) when compared to chemotherapy (mitomycin-C [MMC] or gemcitabine) that is put directly into the bladder (intravesical delivery) in participants with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who have received Bacillus Calmette-Guérin (BCG) treatment, whose disease has come back, and who are ineligible for or elect not to undergo radical cystectomy (removal of bladder).
TAR-200 is a small pretzel-shaped drug delivery system inserted through the urethra into the bladder using an investigational urinary placement catheter (UPC). Once placed in the bladder, TAR-200 releases gemcitabine.
Participants will be randomly assigned equally to Group A (TAR-200) or B (comparator chemotherapy).
This study consists of a Screening Phase (up to 42-days), a Treatment Phase (up to 2 years), and a Follow-up Phase (up to 3 years).
For participants in Group A, TAR-200 will be placed every 3 weeks for the first 6 months, then every 12 weeks through year 2. For participants in Group B, MMC or Gemcitabine will be given once weekly for 6 weeks, then once monthly for at least 12 months (up to 10 maintenance doses). This may be followed by an optional second year of additional maintenance at the Investigator’s discretion. In both groups, the Treatment Phase will be followed by a Follow-up Phase.
Participants who are randomised into Group B and whose disease comes back may be offered the option to crossover and receive treatment with TAR-200.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0028
Date of REC Opinion
15 Mar 2024
REC opinion
Further Information Favourable Opinion