SunRISe-4
Research type
Research Study
Full title
A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
IRAS ID
300063
Contact name
Bartosz Was
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-005565-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
149505, IND
Duration of Study in the UK
3 years, 7 months, 22 days
Research summary
The purpose of this study is to see if an investigational drug delivery system (TAR-200) in combination with intravenous (IV) cetrelimab can improve the results of radical cystectomy (removal of the bladder) as well as reduce disease recurrence in patients with muscle invasive bladder cancer. Eligible participants will have refused of be ineligible for platinum-based neoadjuvant chemotherapy, a standard therapy used prior to radical cystectomy. About 160 participants will take part in this study worldwide. Participants will be randomly assigned, into one of two treatment groups. 100 participants will be assigned to receive TAR-200 in combination with cetrelimab and 60 participants will be assigned to receive cetrelimab alone. TAR-200 is a small, pretzel-shaped investigational drug delivery system that is placed in the bladder where it slowly releases chemotherapy (gemcitabine). TAR-200 is not approved by UK Medicines and Healthcare products Regulatory Agency (MHRA), but gemcitabine, the medication in TAR-200, is approved for use in several other cancer indications, including bladder cancer. Cetrelimab is an investigational medication and is not approved by the UK’s MHRA for bladder cancer. Cetrelimab is being evaluated to treat certain types of cancers and will be given through IV infusion (directly into a vein). The study consists of three parts: screening (to check if participants are right for study), treatment and follow up.
Throughout the study, participants will attend site visits and undergo study tests, including: physical examination; blood and urine collection; bladder tumour biopsies; CT/MRI scans; electrocardiogram; procedures to assess the bladder; and questionnaires.
Participants will receive study treatment until their radical cystectomy, which will occur about 12 weeks after starting treatment. After the surgery, participants will enter a 2 year follow up period when they will return approximately 11 times for health exams and tests.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0251
Date of REC Opinion
10 Dec 2021
REC opinion
Further Information Favourable Opinion