TAR-200 + Cetrelimab for Bladder Cancer
(SunRISe-1 Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a drug-delivery device (TAR-200) and an immune-boosting drug (cetrelimab) in bladder cancer patients who have not responded well to other treatments. TAR-200 releases medicine directly into the bladder, while cetrelimab helps the immune system fight cancer. Cetrelimab is being studied in patients with different types of bladder cancer.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment TAR-200 + Cetrelimab for bladder cancer?
Research shows that TAR-200, which releases gemcitabine directly into the bladder, has been found to be safe and potentially effective in patients with muscle-invasive bladder cancer who cannot undergo standard treatments. Additionally, gemcitabine has shown promising results in improving survival in patients with metastatic bladder cancer.12345
Is the TAR-200 treatment safe for bladder cancer patients?
What makes the TAR-200 + Cetrelimab treatment unique for bladder cancer?
TAR-200 is a unique treatment for bladder cancer because it uses an intravesical drug delivery system to release gemcitabine directly into the bladder over a 21-day cycle, providing localized treatment with potentially fewer side effects compared to systemic chemotherapy. Cetrelimab, combined with TAR-200, may enhance the immune response against cancer cells, offering a novel approach for patients who are unfit for traditional therapies.12578
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for adults with high-risk non-muscle invasive bladder cancer that hasn't responded to BCG therapy and who can't have or chose not to undergo bladder removal surgery. They should be mostly urothelial cancer type, without certain aggressive features, and must have a performance status that allows daily living activities.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TAR-200 and/or Cetrelimab based on cohort assignment. TAR-200 is dosed every 3 weeks for up to 24 weeks, then every 12 weeks through Week 99. Cetrelimab is dosed every 3 weeks through Week 78.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of complete response rate and disease-free survival.
Treatment Details
Interventions
- Cetrelimab
- TAR-200
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires