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8110 Gatehouse Road, Falls Church, VA 22042

Adjuvant study of MK-3475 (pembrolizumab) in muscle invasive and locally advanced urothelial carcinoma (AMBASSADOR) versus observation

General Information

Age Group

Adult

Status

Recruiting

Protocol Number

NCT03244384

Background Information

This randomized phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
 

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • 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 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+ OR, Patients who are not cisplatin-eligible (according to >= 1 of the following criteria: Eastern Cooperative Oncology Group [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 and pathologic stage at surgical resection is >= pT3 or pN+) ORPatients 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+
  • 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
  • No metastatic disease on cross-sectional imaging (according to Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1 criteria)
  • Additional eligibility in protocol

Ineligibility Information

  • 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
  • Additional ineligibility in protocol

Additional information can be found at https://clinicaltrials.gov/ct2/show/study/NCT03244384