A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder
Bladder Cancer
Unknown Primary
18 Years and older, Male and Female
CR109044 (primary)
NCI-2022-05645
17000139BLC2002
2020-005565-13
Summary
The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination
with intravenous (IV) cetrelimab and IV cetrelimab alone.
Objectives
Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent
(%) of all new bladder cancer participants present with muscle invasive bladder cancer
(MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant
metastases. The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug
delivery system regulated as an investigational drug. The drug constituent consists of
gemcitabine minitablets 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 standard of care in MIBC includes radical cystectomy (RC) with
urinary diversion and is considered the preferred treatment option for participants who
are considered surgical candidates. Study consists of a Screening phase, Treatment phase
and follow-up phase. The total duration of study will be up to 2 years and 6 months.
Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time
points during this study.
Eligibility
- Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 120 days of randomization date. Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial predominance. However, the presence of small cell or neuroendocrine variants will make a participant ineligible
- Participants with no residual tumor, or intravesical tumor size of less than or equal to (<=)3 centimeter (cm) following transurethral resection of bladder tumor (TURBT) are eligible; debulking TURBT for any residual disease is encouraged but not mandated. Participants with persistent tumors greater than (>)3 cm at screening must undergo a second debulking, re-staging TURBT. Participants will be ineligible if any individual tumor is >3 cm after debulking TURBT
- Deemed eligible for and willing to undergo RC by the operating urologist
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1
- Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results
- All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization
Treatment Sites in Georgia
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