A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (SunRISe-1)
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- STATUS
- Recruiting
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- End date
- Jul 2, 2027
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- participants needed
- 200
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- sponsor
- Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease.
Description
Bladder cancer is the tenth most common type of cancer worldwide. The natural history of high-risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) is unpredictable; rates of recurrence vary from 15 percent (%) to 78%, and rates of progression to muscle invasion and metastasis vary from less than (<) 1 to 45%. The gemcitabine 225 milligrams (mg) intravesical delivery system (JNJ-17000139) product (hereafter, TAR-200) is an investigational integral product that is comprised of a drug and device components. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein 1 (PD-1). This study consists 3 periods: screening phase (up to 42 days); treatment phase (up to 2 years); follow up phase (up to 5 years). Total duration of study is up to 6 year and 7 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specified time points during this study.
Details
| Condition | Urinary Bladder Neoplasms |
|---|---|
| Treatment | Cetrelimab, TAR-200 |
| Clinical Study Identifier | NCT04640623 |
| Sponsor | Janssen Research & Development, LLC |
| Last Modified on | 4 April 2023 |
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