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TAR-200

DRUG7 trials

Sponsors

Janssen Research & Development, LLC

Conditions

Bladder CancerNon-Muscle Invasive Bladder NeoplasmsUrinary Bladder Neoplasms

Phase 1

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
CompletedNCT03404791
Janssen Research & Development, LLCUrinary Bladder Neoplasms
Start: 2017-11-20End: 2022-09-15Updated: 2025-02-04

Phase 2

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
Active, not recruitingNCT04640623
Janssen Research & Development, LLCUrinary Bladder Neoplasms
Start: 2020-12-18End: 2027-09-30Updated: 2026-03-13
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
Active, not recruitingNCT04919512
Janssen Research & Development, LLCUrinary Bladder Neoplasms
Start: 2022-07-07End: 2026-03-31Updated: 2026-03-25

Phase 3

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
Active, not recruitingNCT04658862
Janssen Research & Development, LLCUrinary Bladder Neoplasms
Start: 2020-12-07End: 2028-12-31Updated: 2026-03-19
A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)
Active, not recruitingNCT05714202
Janssen Research & Development, LLCBladder Cancer
Start: 2023-03-23End: 2029-09-18Updated: 2026-03-19
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
Active, not recruitingNCT06211764
Janssen Research & Development, LLCNon-Muscle Invasive Bladder Neoplasms
Start: 2024-04-09End: 2031-04-14Updated: 2026-03-17

Unknown Phase

Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
NCT06877676
Janssen Research & Development, LLCNon-Muscle Invasive Bladder Neoplasms
Updated: 2026-02-13

Related Papers

Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results.
2025-12-031 citations
TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial.
2025-08-273 citations
The Evolving Landscape of Systemic Immunotherapy for Bacillus Calmette-Guérin-naïve High-risk Non-muscle-invasive Bladder Cancer: At the Edge of a Tsunami?
2025-08-051 citations
TAR-200 for Bacillus Calmette-Guérin–Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study
Journal of Clinical Oncology2025-07-3010 citations
P2-01 TAR-200 IN PATIENTS WITH BACILLUS CALMETTE–GUÉRIN-UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER: RESULTS FROM SUNRISE-1 STUDY
The Journal of Urology2024-05-0111 citations
The Safety, Tolerability, and Preliminary Efficacy of a Gemcitabine-releasing Intravesical System (TAR-200) in American Urological Association-defined Intermediate-risk Non-muscle-invasive Bladder Cancer Patients: A Phase 1b Study.
2024-02-1615 citations
Reasons for refusal of or ineligibility for radical cystectomy (RC) in patients (Pts) with bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) from the SunRISe-1 study.
Journal of Clinical Oncology2024-01-291 citations
SunRISe-4: TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant platinum-based chemotherapy.
Journal of Clinical Oncology2023-02-209 citations
First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers
Cancer Chemotherapy and Pharmacology2022-03-1723 citations
SunRISe-1: Phase 2b study of TAR-200 plus cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk nonmuscle-invasive bladder cancer unresponsive to Bacillus Calmette-Guérin who are ineligible for or decline radical cystectomy.
Journal of Clinical Oncology2022-02-1611 citations
MP13-17 SUNRISE-2: A PHASE 3, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY OF TAR-200 IN COMBINATION WITH CETRELIMAB VERSUS CONCURRENT CHEMORADIOTHERAPY IN PARTICIPANTS WITH MUSCLE-INVASIVE UROTHELIAL CARCINOMA OF THE BLADDER
The Journal of Urology2021-08-043 citations
A phase 3, multicenter, randomized study evaluating the efficacy of TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy in participants with muscle-invasive urothelial carcinoma of the bladder.
Journal of Clinical Oncology2021-05-205 citations