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A Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma Versus Observation.

Research & Trial Information

SCHEMA

Protocol#: Alliance – A031501

Cancer Type: Bladder

Patient Eligibility:

  1. Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract or LN+ disease. Variant histology allowed as long as urothelial carcinoma is predominant (any amount of squamous differentiation is allowed). Pure small-cell carcinoma is excluded.
  2. Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder tumor, upper tract resection, or radical cystectomy/nephrectomy/ureterectomy/nephroureterectomy must be available. This specimen submission is mandatory prior to registration as results will be used for stratification. Specimens from radical/definitive surgery (radical  ystectomy/nephrectomy/ureterectomy/nephroureterectomy and LN dissection) are preferred over transuretheral resection, if available.
  3. Patient must fit into one of the following three categories: surgical resection is ≥ pT2 and/or N+Patients who received neoadjuvant chemotherapy and pathologic stage at OR Patients who are not cisplatin-eligible (according to ≥ 1 of the following criteria: ECOG performance status of 2, creatinine clearance < 60 mL/min, grade ≥ 2 hearing loss, grade ≥ 2 neuropathy, or New York Heart Association Class III heart failure [38]) and pathologic stage at surgical resection is ≥ pT3 or pN+) OR Patients that decline adjuvant cisplatin-based or other systemic chemotherapy based on an informed discussion with the physician and pathologic stage at surgical resection is ≥ pT3 or pN+.
  4. Patient must have had radical cystectomy, nephrectomy, nephroureterectomy or ureterectomy ≥4 weeks but ≤ 16 weeks prior to pre-registration.
  5. No gross cancer at the surgical margins. Microscopic invasive positive margins are allowed. CIS at margins is considered negative margins.
  6. No evidence of residual cancer or metastasis after surgery.
  7. No postoperative/adjuvant systemic therapy.
  8. No prior treatment with any therapy on the PD-1/PD-L1 axis.
  9. No treatment with any other type of investigational agent ≤ 4 weeks before preregistration.
  10. No major surgery ≤ 4 weeks before pre-registration.
  11. No radiation therapy ≤ 4 weeks before pre-registration.
  12. No neoadjuvant chemotherapy ≤ 4 weeks before pre-registration.
  13. Not currently requiring hemodialysis.
  14. Age ≥ 18 years
  15. ECOG Performance Status ≤ 2.
  16. Results of central PD-L1 testing available.

 

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