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
2期
进行中（已停止招募）
NCT04640623
| 适应症 | Urinary Bladder Neoplasms |
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| 分期 | 2期 |
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| 申办方 | Janssen Research & Development, LLC |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 220 人 |
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| 干预（药物） | TAR-200, Cetrelimab |
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| 开始日期 | 2020年12月18日 |
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| 完成日期 | 2025年7月3日 |
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| 结果公布日 | 2026年7月29日 |
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摘要
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; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months) · percentage of participants
| Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease) | 67.9 percentage of participants |
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| Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease) | 82.4 percentage of participants |
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| Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease) | 46.4 percentage of participants |
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Cohort 4: Disease-free Survival (DFS)
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months) · months
| Cohort 4: TAR-200 Monotherapy (Papillary Disease Only) | NA months |
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