220 Participants Needed

TAR-200 + Cetrelimab for Bladder Cancer

(SunRISe-1 Trial)

Recruiting at 171 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

TAR-200, a system that releases gemcitabine directly into the bladder, has been studied for safety in patients with muscle-invasive bladder cancer. The studies found it to be generally safe and tolerable for patients who were either unfit for or refused more aggressive treatments.12367

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

JR

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

I am able to care for myself and perform daily activities.
My bladder cancer did not respond to a full course of BCG treatment.
My tumor is mainly urothelial but doesn’t have certain aggressive features.
See 5 more

Exclusion Criteria

I have not received a live virus vaccine in the last 30 days.
I don't have active hepatitis B or C, or it's undetectable.
My bladder cancer has not spread outside the bladder, except possibly for early-stage cancer in the upper urinary tract treated over 2 years ago.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 99 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of complete response rate and disease-free survival.

Up to 5 years

Treatment Details

Interventions

  • Cetrelimab
  • TAR-200
Trial OverviewThe study tests TAR-200 (a drug-device combination) and Cetrelimab (an immunotherapy), alone or in combination, in four different participant groups based on their specific type of bladder cancer. The main goals are to see if the treatments completely remove the cancer or prevent it from returning.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Cohort 4: TAR-200 (Participants with Papillary Disease only)Experimental Treatment1 Intervention
TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Group II: Cohort 3: CetrelimabExperimental Treatment1 Intervention
Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months).
Group III: Cohort 2: TAR-200Experimental Treatment1 Intervention
TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2).
Group IV: Cohort 1: TAR-200 and CetrelimabExperimental Treatment2 Interventions
TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Giacomo Salvadore profile image

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar profile image

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

TAR-200, a novel drug delivery system for gemcitabine, was found to be generally safe and well tolerated in a study of 35 elderly patients with muscle-invasive bladder cancer who were unfit for standard treatment.
The treatment showed promising preliminary efficacy, with a 40% overall response rate and a median overall survival of 27.3 months, indicating it could be a valuable option for patients with limited treatment choices.
Safety, Tolerability, and Preliminary Efficacy of TAR-200 in Patients With Muscle-invasive Bladder Cancer Who Refused or Were Unfit for Curative-intent Therapy: A Phase 1 Study.Tyson, MD., Morris, D., Palou, J., et al.[2023]
The TAR-200 system for delivering gemcitabine directly into the bladder was found to be safe and well tolerated in a phase I study involving 23 patients with muscle-invasive bladder cancer (MIBC), with no intolerable side effects reported.
Preliminary efficacy results showed that a significant number of patients experienced pathologic downstaging after treatment, with some achieving complete or partial responses, indicating potential effectiveness of this localized treatment approach.
The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial.Daneshmand, S., Brummelhuis, ISG., Pohar, KS., et al.[2022]
The combination of gemcitabine and irinotecan (Irinogem) showed promising efficacy in treating metastatic bladder cancer, with 8 out of 13 evaluable patients achieving an objective response, including 2 complete responses and 6 partial responses, and a median progression-free survival of 8.78 months.
The treatment was associated with manageable toxicity, with no toxic deaths reported, although some patients experienced significant side effects like neutropenia and diarrhea. However, the study's early closure due to funding issues limits the ability to draw definitive conclusions.
A phase II study of gemcitabine and irinotecan in patients with locally advanced or metastatic bladder cancer.Chaudhary, UB., Verma, N., Keane, T., et al.[2022]

References

Safety, Tolerability, and Preliminary Efficacy of TAR-200 in Patients With Muscle-invasive Bladder Cancer Who Refused or Were Unfit for Curative-intent Therapy: A Phase 1 Study. [2023]
The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial. [2022]
A phase II study of gemcitabine and irinotecan in patients with locally advanced or metastatic bladder cancer. [2022]
Maintenance treatment with gemcitabine have a promising activity on metastatic bladder cancer survival. [2020]
Systemic therapy in muscle-invasive and metastatic bladder cancer: current trends and future promises. [2017]
Gemcitabine and carboplatin combination as first-line treatment in elderly patients and those unfit for cisplatin-based chemotherapy with advanced bladder carcinoma: Phase II study of the Hellenic Co-operative Oncology Group. [2022]
Atezolizumab in invasive and metastatic urothelial carcinoma. [2019]
8.Czech Republicpubmed.ncbi.nlm.nih.gov
[Immunotherapy for Bladder Cancer]. [2019]