Clinical Trials Logo
  1. Home
  2. Urinary Bladder Neoplasms
  3. NCT04919512

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder — SunRISe-4  

Urinary Bladder Neoplasms Clinical Trial

Official 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

Clinical Trial Summary

The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

Clinical Trial Description

Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent (%) of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant metastases. The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine minitablets and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The standard of care in MIBC includes radical cystectomy (RC) with urinary diversion and is considered the preferred treatment option for participants who are considered surgical candidates. Study consists of a Screening phase, Treatment phase and follow-up phase. The total duration of study will be up to 2 years and 6 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04919512
Study type Interventional
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Status Recruiting
Phase Phase 2
Start date July 7, 2022
Completion date March 16, 2027
View Details
See also
  Status Clinical Trial Phase
Terminated NCT02612194 - LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer Phase 2
Active, not recruiting NCT02805608 - uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer Phase 2
Not yet recruiting NCT02534623 - Postoperative Quality of Recovery After Transurethral Resection of the Bladder N/A
Recruiting NCT02228473 - Effect of Glycopyrrolate and Atropine on Catheter-Related Bladder Discomfort N/A
Completed NCT02778243 - Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level N/A
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Completed NCT01688999 - Cabozantinib for Advanced Urothelial Cancer Phase 2
Completed NCT03219333 - A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer Phase 2
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Terminated NCT02560038 - Trial of Paclitaxel Plus Gemcitabine and Cisplatin in Bladder Cancer Phase 2
Not yet recruiting NCT02252445 - Propofol and Sevoflurane for Catheter-Related Bladder Discomfort N/A
Not yet recruiting NCT02760953 - TURBt With Adjuvant Cryoablation to Treat Bladder Cancer N/A
Terminated NCT04430036 - AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer Phase 2
Active, not recruiting NCT06289283 - Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder
Active, not recruiting NCT03288545 - A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer Phase 1/Phase 2
Active, not recruiting NCT03661320 - A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer Phase 3
Completed NCT01478685 - A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors Phase 1
Completed NCT03404791 - A Study of TAR-200 in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who Are Unfit for Radical Cystectomy Phase 1
Terminated NCT01479348 - Imaging Study for FdCyd and THU Cancer Treatment Early Phase 1
Recruiting NCT05742867 - A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder