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
第2相
実施中（募集終了）
NCT04640623
| 対象疾患 | Urinary Bladder Neoplasms |
|---|
| 相 | 第2相 |
|---|
| スポンサー | Janssen Research & Development, LLC |
|---|
| ステータス | 実施中（募集終了） |
|---|
| 参加者数 | 220 名 |
|---|
| 介入（薬剤） | TAR-200, Cetrelimab |
|---|
| 開始日 | 2020年12月18日 |
|---|
| 完了日 | 2025年7月3日 |
|---|
| 結果公開日 | 2026年7月29日 |
|---|
概要
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 |
|---|
| Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease) | 82.4 percentage of participants |
|---|
| Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease) | 46.4 percentage of participants |
|---|
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 |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。