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

Research & Trial Information

SCHEMA A031501

Protocol #: A031501

Cancer Type: GU Bladder

Eligibility Criteria:

  1. Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract. Variant histology allowed as long as urothelial carcinoma is predominant (>50%). Pure small-cell carcinoma is excluded.
  2. Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder tumor, upper tract resection, cystectomy/nephrectomy/ureterectomy, or nephroureterectomy must be available. This specimen submission is mandatory prior to registration as results will be used for stratification. See Section 6.2 for details on specimen submission.
  3. Patient must fit into one of the following three categories:• Patients who received neoadjuvant chemotherapy and pathologic stage at surgical resection is ≥ pT2 and/or N+


    • 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+)


    • 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 surgical resection of their bladder cancer ≥4 weeks but ≤ 16 weeks prior to pre-registration. No invasive cancer at the surgical margins. No evidence of residual cancer or metastasis after surgery.
  5. No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids.
  6. No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.
  7. Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
  8. Patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  9. No postoperative/adjuvant systemic therapy.
  10. No prior treatment with any therapy on the PD-1/PD-L1 axis.
  11. No treatment with any other type of investigational agent ≤ 4 weeks before pre-registration.
  12. No major surgery ≤ 4 weeks before pre-registration.
  13. No radiation therapy ≤ 4 weeks before pre-registration.
  14. No neoadjuvant chemotherapy ≤ 4 weeks before pre-registration.
  15. Age ≥ 18 years.
  16. ECOG Performance Status ≤ 2 



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