Urinary Bladder Neoplasms
Conditions
Brief summary
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.
Interventions
DRUGTAR-200
TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Up to Day 84 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Clinical Partial Response (cPR) | Up to Day 360 | 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). |
| Percentage of Participants with Stable Disease (SD) | Up to Day 360 | 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). |
| Percentage of Participants with Disease Progression | Up to Day 360 | 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) |
| Symptom Control | Up to Day 360 | Symptom Control is defined as changes in bladder-related symptoms per the protocol-specified bladder symptom (Urinary frequency, Nocturia, Hematuria and Dysuria/pain) and toxicity grading system (Grade 0-3). |
| Percentage of Participants with Clinical Complete Response (cCR) | Up to Day 360 | 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 to Progression | Up to Day 360 | Time to progression, defined as the time from the date of the first TAR-200 insertion to the date of first occurrence of progression. |
| Percentage of Participants Undergoing Post-treatment Interventions by 3, 6, 9, and 12 Months | Up to 3, 6, 9, and 12 Months | Percentage of participants undergoing post-treatment interventions for the management of local symptoms by 3, 6, 9, and 12 months. |
| Percentage of Participants Surviving at 12, 24, and 36 Months | At 12, 24, and 36 months | Percentage of participants surviving at 12, 24, and 36 months compared to all participants. |
| Time to Intervention for Symptom Control | Up to Day 360 | Time to intervention for symptom control, defined as the time from the date of the first TAR-200 insertion to the date of intervention for symptom palliation. |
Countries
Spain, United States
Outcome results
None listed