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
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)
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) Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.
Cohort 4: Disease-free Survival (DFS) — From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months) DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause.
Trial sites (144)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.