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

Janssen Research & Development, LLC35 enrolled

Overview

The purpose of this study is to evaluate both the safety and tolerability of up to 4 dosing cycles of TAR-200 for 21 days per dosing cycle in the induction period.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Bladder Neoplasms

Interventions

TAR-200DRUG

TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder * Participant must have been as fully resected as possible per the physician's judgment * Participants must be deemed unfit for RC due to comorbid conditions with a risk of mortality * Participants must refuse or be deemed ineligible for cisplatin-based chemotherapy * Participant must refuse or not be eligible for radiotherapy Exclusion Criteria: * Other active malignancies * Presence of any bladder or urethral anatomic feature that in the opinion of the Investigator may prevent the safe placement, indwelling use, or removal of TAR-200 * Pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy tube is allowed) * Evidence of bladder perforation during diagnostic cystoscopy * Concurrent clinically significant infections as determined by the treating Investigator

Locations (12)

Mayo Clinic Arizona

Phoenix, Arizona, United States

North Georgia Urology Center

Dalton, Georgia, United States

Chesapeake Urology Research Associates

Hanover, Maryland, United States

Outcomes

Primary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

An Adverse Event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study.

Time frame: Up to Day 84

Secondary Outcomes

Percentage of Participants with Clinical Complete Response (cCR)

Percentage of Participants with Clinical Complete Response (cCR) will be reported as assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated).

Time frame: Up to Day 360

Percentage of Participants with Clinical Partial Response (cPR)

Percentage of participants with clinical partial response (cPR) will be reported as assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated).

Time frame: Up to Day 360

Percentage of Participants with Stable Disease (SD)

Percentage of participants with stable disease (SD) will be reported as assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated).

Time frame: Up to Day 360

Percentage of Participants with Disease Progression

Percentage of participants with disease progression as assessed by cystoscopy, pelvic computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and biopsy (at 12 weeks only, unless clinically indicated)

Time frame: Up to Day 360

Data from ClinicalTrials.gov

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