Protocol Title: A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants with BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)

Sponsor: Janssen

Protocol Number: 17000139BCL3002 “SUNRISE3”

Key Criteria

·         Histologically confirmed initial diagnosis by local pathology (within 90 days of consent) of HR-NMIBC (high-grade Ta, any T1 or CIS).
·         Naïve to prior intravesical BCG or who previously received but stopped BCG more than 3 years
·         Willing to do TURBT/bladder biopsy for assessment of recurrence/progression
·         papillary disease must be fully resected (absent)
EXCLUDED if:
·         Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (ie, ≥T2).
·         Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (ie, 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.

Talking Points

  1. Histologically confirmed initial diagnosis: The patient’s diagnosis of high-grade non-muscle invasive bladder cancer (HR-NMIBC) has been confirmed by local pathology within the last 90 days. This ensures that the patient meets the specific criteria for the clinical trial.
  2. Naïve to prior intravesical BCG or previous BCG treatment stopped more than 3 years ago: The patient has not received intravesical BCG treatment before or has stopped BCG therapy more than 3 years ago. This criterion allows us to focus on patients who have not recently undergone this specific treatment.
  3. Willingness to undergo TURBT/bladder biopsy: The patient should be willing to undergo transurethral resection of the bladder tumor (TURBT) or bladder biopsy for the assessment of recurrence or progression. This procedure is crucial for monitoring the patient’s response to treatment and evaluating the efficacy of the clinical trial intervention.
  4. Absence of papillary disease: The patient’s papillary disease must be fully resected and absent. This means that any papillary tumors have been completely removed. The absence of papillary disease ensures a specific focus on the target population for the clinical trial.
  5. Exclusion criteria: The patient must not have muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma beyond T2 stage. This exclusion criterion ensures that the trial is targeting patients with a specific stage of bladder cancer and provides a clear delineation for the trial’s objectives.
  6. No urothelial carcinoma or histological variant outside the urinary bladder: The patient must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder, including the urethra, ureter, or renal pelvis. Exceptions include Ta/any T1/CIS of the upper urinary tract if the patient has undergone complete nephroureterectomy more than 24 months prior to randomization. This criterion ensures that the trial focuses on patients with bladder cancer specifically, without other concurrent or previous urothelial carcinoma involvement.

Based on these criteria, this clinical trial would be a suitable option for the patient as they meet the inclusion criteria and do not have any of the exclusion criteria mentioned above. It is important to explain the potential benefits and risks of participating in the trial to the patient, as well as the relevance of their specific characteristics in relation to the trial’s objectives.

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