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Alliance A031501

Trial

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

Open to Enrollment

Start Date

August 11, 2020

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

Principal Investigator Name

Mei Dong, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:58 PM