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
2상
진행 중(모집 완료)
NCT04640623
| 대상 질환 | Urinary Bladder Neoplasms |
|---|
| 임상 단계 | 2상 |
|---|
| 스폰서 | Janssen Research & Development, LLC |
|---|
| 상태 | 진행 중(모집 완료) |
|---|
| 참여자 수 | 220 명 |
|---|
| 중재(약물) | TAR-200, Cetrelimab |
|---|
| 시작일 | 2020년 12월 18일 |
|---|
| 완료일 | 2025년 7월 3일 |
|---|
| 결과 공개일 | 2026년 7월 29일 |
|---|
요약
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 |
|---|
BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
전체 임상
이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.