SunRISe-3
Research type
Research Study
Full 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 (HR-NMIBC)
IRAS ID
1005621
Contact name
Scott Banks
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-004506-64
Clinicaltrials.gov Identifier
Research summary
This is a multi-center, open-label, randomised Phase 3 study to compare the effects of the investigational drug delivery system TAR-200 on its own or in combination with cetrelimab, to the effects of the study drug comparator intravesical (medicine that is put directly into the bladder) Bacillus Calmette-Guérin (BCG) in participants with BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC).
Participants will be randomly assigned 1:1 to treatment with either TAR-200 in combination with IV cetrelimab (Treatment Group A) or intravesical BCG alone (Treatment Group B).
TAR-200 is a drug delivery system which releases a drug named gemcitabine (an anti-cancer chemotherapy drug) into the bladder. During treatment it will remain inside the bladder for approximately 21 days after each insertion. It will then be removed and replaced with another TAR-200 system as per the treatment schedule.
Cetrelimab is a medicine that may treat certain cancers by working with the immune system (known as immunotherapy). Cetrelimab is delivered intravenously (IV, directly into a vein).
BCG, a weak form of bacteria, is an immunotherapy that activates the body’s immune system to attack cancer cells. It is intended for placement into the bladder as a topic rinse (i.e., it does not enter bloodstream). BCG is a routine treatment for bladder cancer.
The study will consist of a Screening Phase, a Treatment Phase (with visit schedules determined by treatment group and clinical status), and a Follow-up Phase.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0063
Date of REC Opinion
18 Aug 2023
REC opinion
Further Information Favourable Opinion