A study to compare TAR-200 (drug delivery system with gemcitabine) and Cetrelimab v/s TAR-200 Alone v/s Intravesical Bacillus Calmette-Guérin (BCG) in patients who have not received BCG treatment for High-risk Non-muscle Invasive Bladder Cancer.
- Conditions
- Health Condition 1: C679- Malignant neoplasm of bladder, unspecified
- Registration Number
- CTRI/2023/07/054818
- Lead Sponsor
- Johnson and Johnson Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Histologically confirmed initial diagnosis by local pathology (within 90 days of the initial 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. 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.
2. 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).
3. All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy.
4. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2.
5. 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.
6. Participants must be willing to undergo all study procedures.
1. Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to T2).
2. Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any 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.
3. Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded.
4. A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL).
5. Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free Survival (EFS)Timepoint: Upto 5 years 2 months
- Secondary Outcome Measures
Name Time Method