Alliance A031501

Clinical Trial Title Phase III randomized “Adjuvant study of MK-3475 (pembrolizumab) in muscle invasive and locally advanced urothelial carcinoma” (AMBASSADOR) versus observation
Trial Status Closed to Enrollment
Start Date 08/11/2020
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Bladder Cancer and Urothelial Cancer
Description This randomized phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.
Eligibility Criteria

Pre-Registration Eligibility Criteria

  • Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, urethra, upper tract, or LN+ disease. Variant histology allowed as long as urothelial carcinoma is predominant (any amount of squamous differentiation is allowed). Any component of neuroendocrine carcinoma is excluded.
  • Patient must have had radical cystectomy (cystoprostatectomy for men) and lymph node dissection (for bladder primary), or nephrectomy, nephroureterectomy or ureterectomy (for uppertract tumors) or urethrectomy (in addition to a radical cystectomy-either simultaneously or in the past) ≥4 weeks but ≤ 16 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible.
  • No evidence of residual cancer or metastasis after surgery.
  • No metastatic disease (or radiologic findings "concerning" for metastatic disease) on cross-sectional imaging.
  • No postoperative/adjuvant systemic therapy.
  • No prior treatment with any therapy on the PD-1/PD-L1 axis.
  • No treatment with any other type of investigational agent ≤ 4 weeks before pre-registration
  • No major surgery ≤ 4 weeks before pre-registration
  • No radiation therapy ≤ 4 weeks before pre-registration
  • No neoadjuvant chemotherapy ≤ 4 weeks before pre-registration
  • Age ≥ 18 years
  • ECOG Performance Status ≤ 2

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT03244384?term=A031501
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org