SunRISe-1
Research type
Research Study
Full title
Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination with Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants with High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin (BCG) who are Ineligible for or Elected Not to Undergo Radical Cystectomy
IRAS ID
291570
Contact name
James Catto
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-002646-16
Clinicaltrials.gov Identifier
149505, IND; EDMS-ERI-207623971, 2.0, EDMS number
Duration of Study in the UK
7 years, 8 months, 4 days
Research summary
Bladder cancer is the tenth most common malignancy worldwide, with an estimated 549,000 new cases and 200,000 deaths reported in 2018. Seventy percent of these patients are diagnosed with early stage non-muscle invasive bladder cancer (NMIBC). Approximately 25% of NMIBC patients have high-risk, non-muscle invasive bladder cancer. Long-term outcomes suggest that approximately 20% to 25% of these patients die from bladder cancer.
The purpose of this study is to see if an investigational medication/device (gemcitabine/TAR-200) alone, cetrelimab alone or TAR-200 in combination with cetrelimab is safe and decreases the number of bladder cancer cells in patients with non-muscle invasive bladder cancer (NMIBC).
The TAR-200 platform is an innovative advancement in the field of urologic medication delivery that has the potential to be a less invasive and more effective treatment than urethral catheterisation for the delivery of therapeutic agents, such as gemcitabine, to the bladder.
About 200 patients will take part in this study worldwide. Patients will be randomly assigned like the roll of a dice, to receive either TAR-200 plus cetrelimab (100 patients will receive this study medication), TAR-200 alone (50 patients will receive this study medication), or cetrelimab alone (50 patients will receive this study medication). Participants may receive treatment for up to 2 years and they may be followed for up to 5 years.
Participants will visit their research site at least every 3 weeks for 24 weeks (6 months) and then every 12 weeks (3 months) through Year 2.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
21/NW/0012
Date of REC Opinion
21 Jan 2021
REC opinion
Favourable Opinion