🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT04640623
Active, not recruiting 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

NCT04640623 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2020-12-18
Last updated
2026-08-28

Condition(s) studied

Urinary Bladder Neoplasms

Investigational drug(s) / intervention(s)

TAR-200Cetrelimab

TAR-200: TAR-200 will be administered transuretherally.

Cetrelimab: Cetrelimab will be administered.

Study 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; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ \[CIS\] or tumor in situ \[Tis\]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC) * All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma \[HGUC\]) * Participants must be ineligible for or have elected not to undergo radical cystectomy * BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2 Exclusion Criteria: * Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV) * Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization * Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed * Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed) * Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

Primary outcome measure(s)

Trial sites (144)

FacilityCityRegionStatus
Del Sol Research Management, LLC Tucson Arizona
University of Southern California Los Angeles California
Genesis Healthcare Partners - Genesis Research Greater Los Angeles Sherman Oaks California
The Urology Center of Colorado Denver Colorado
Foothills Urology - Golden Off Golden Colorado
DuPage Medical Group Lisle Illinois
Urology of Indiana Greenwood Indiana
Wichita Urology Group Wichita Kansas
Michigan Institute of Urology Troy Michigan
NYU Langone Health New York New York
SUNY Upstate Medical University Syracuse New York
Associated Medical Professionals Syracuse New York
Levine Cancer Institute Charlotte North Carolina
The Urology Group Cincinnati Ohio
Urologic Consultants of Southeastern Pennsylvania Bala-Cynwyd Pennsylvania
Thomas Jefferson University Philadelphia Pennsylvania
Urology Associates, PC Nashville Tennessee
Vanderbilt University Medical Center Nashville Tennessee
Urology Austin Austin Texas
University of Texas Southwestern Medical Center Dallas Texas
Urology San Antonio Research San Antonio Texas
Spokane Urology Spokane Washington
Flinders Medical Centre Bedford Park Australia
Eastern Health Research Box Hill Australia
Macquarie University Hospital Sydney Australia
AZ Sint-Lucas Brugge Assebroek Belgium
AZ Sint-Jan Brugge Bruges Belgium
Hopital Erasme Brussels Belgium
Algemeen ziekenhuis Maria Middelares Ghent Belgium
Universitair Ziekenhuis Gent Ghent Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
AZ Nikolaas Sint-Niklaas Belgium
Exdeo Clinical Research Inc Abbotsford British Columbia British Columbia
William Osler Health System Brampton Ontario
Princess Margaret Hospital- UHN Toronto Ontario
McGill University Health Centre Montreal Quebec
Universite de Sherbrooke Sherbrooke Quebec
Hopital Pellegrin CHU Bordeaux Bordeaux France
Polyclinique Bordeaux Nord Acquitaine Bordeaux France
CHU Grenoble Grenoble France

+ 104 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04640623 on ClinicalTrials.gov ↗ ← All trials in the UK