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)
Bladder Cancer
Unknown Primary
18 Years and older, Male and Female
CR109223 (primary)
NCI-2023-05193
17000139BLC3002
2020-004506-64
Summary
The purpose of this study is to compare event-free survival (EFS) in participants with
Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer
(HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS),
between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical
BCG (Group B).
Objectives
Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of
bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC
patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an
intravesical drug delivery system regulated as an investigational drug. The drug
constituent consists of gemcitabine and osmotic minitablets. Cetrelimab (JNJ-63723283) is
a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds
programmed-cell death protein (PD)-1. The mainstay of treatment for HR-NMIBC is
transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In
this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or
in combination with cetrelimab will be evaluated and compared against intravesical BCG.
The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total
duration of the study will be up to 5 years and 2 months. Efficacy, Safety,
pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the
study.
Eligibility
- Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve
- BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)
- All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
- All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to date of randomization
- Participants must be willing to undergo all study procedures
Treatment Sites in Georgia
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