Health Condition 1: C679- Malignant neoplasm of bladder, unspecified
Conditions
Interventions
Intervention1: Treatment Group A: TAR-200 (225mg gemcitabine) and Cetrelimab (360mg): Participants will receive intravesical TAR-200 once every 3 weeks for 24 weeks and then once every 12 weeks (maint
Sponsors
Johnson and Johnson Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free Survival (EFS)Timepoint: Upto 5 years 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the overall complete response (CR) rate and the duration of CR in participants with BCG-naïve CIS receiving TAR-200 & IV cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B). Overall CR will be measured by determining the percentage of participants with CIS who have no presence of high-risk disease at 6 months.Timepoint: Up to 5 years 2 months;Duration of CR: Duration of CR is defined from the time of first CR achieved to first evidence of recurrence, progression or death due to any cause (whichever occurs first) for participants who achieve a CR.Timepoint: Up to 5 years 2 months;To compare recurrence-free survival (RFS) in participants with BCG-naïve HR-NMIBC high-grade papillary Ta or any T1, receiving TAR-200 & IV cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B). RFS is defined as the time from randomization to the time of the first recurrence of high-risk disease, or death due to any cause, whichever occurs first.Timepoint: Up to 5 years 2 months;To compare time to progression (TTP) in participants with BCG-naïve HR-NMIBC high-grade papillary Ta or any T1 or CIS receiving TAR-200 & IV cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B). TTP is defined as the time from randomization to the date of first documented evidence of disease progression or death due to disease progression, whichever occurs first.Timepoint: Up to 5 years 2 months;To compare overall survival (OS) in participants with BCG-naïve HR-NMIBC, high-grade papillary Ta or any T1, or CIS receiving TAR-200 & IV cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B). OS is defined as the time from randomization to death, due to any cause.Timepoint: Up to 5 years 2 months;To compare cancer specific survival (CSS) in participants with BCG-naïve HR-NMIBC, highgrade papillary Ta or any T1, or CIS receiving TAR-200 & IV cetrelimab (Group A) and TAR-200 alone | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Republic of Korea, Spain, Taiwan, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson and Johnson Private Limited
Outcome results
None listed