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Urothelial
General Information
Study Name:
Adjuvant study of MK-3475 (pembrolizumab) in muscle invasive and locally advanced urothelial carcinoma (AMBASSADOR) versus observation
Age Group:
Adult
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
Contact Information
Contact Name:
Perry Montgomery, RN, BSN
Contact Phone:
571-472-0625
Contact Email:
perry.montgomery@inova.org
Additional information can be found at
https://clinicaltrials.gov/ct2/show/study/NCT03244384