Skip Navigation Links
PHASE III RANDOMIZED ADJUVANT STUDY OF MK-3475 (PEMBROLIZUMAB) IN MUSCLE INVASIVE AND LOCALLY ADVANCED UROTHELIAL CARCINOMA (AMBASSADOR) VERSUS OBSERVATION (A031501)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
PHASE III RANDOMIZED ADJUVANT STUDY OF MK-3475 (PEMBROLIZUMAB) IN MUSCLE INVASIVE AND LOCALLY ADVANCED UROTHELIAL CARCINOMA (AMBASSADOR) VERSUS OBSERVATION (A031501)
 
Region Sponsors
Northwest
National Cancer Institute (NCI)
 
Acronym KP IRB No.
STUDY00000797
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Stage II Bladder Urothelial Carcinoma AJCC v6 and v7; Stage III Bladder Urothelial Carcinoma AJCC v6 and v7;
 
Purpose
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.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • 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
  • 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
  • Patient must fit into one of the following three categories: 1. Patients who received neoadjuvant chemotherapy and pathologic stage at surgical resection is >= pT2 and/or N+ OR 2. 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+) OR 3. 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+ Patient must have had radical surgical resection of their bladder cancer >= 4 weeks but =< 16 weeks prior to pre-registration
  • ECOG performance status =< 2
  • Absolute neutrophil count (ANC) >= 1,200/mm^3
  • Leukocytes >= 3,000/ mm^3
  • Platelet count >= 75,000/mm^3
  • Hemoglobin >= 9 g/dL or >= 5.6 mmol/L
  • Please contact study personnel for more eligibility criteria
 
Exclusion Criteria
  • 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)
  • 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. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravi, systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease. Human immunodeficiency virus (HIV) (+) patients are eligible as long as they have: cd4 > 200, undetectable viral load and on highly active antiretroviral therapy (HAART) therapy No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years
  • No known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) 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
  • Please contact study personnel for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • AJCC v6 and v7
  • Stage II
  • Bladder Urothelial Carcinoma
  • Stage III
  • Bladder Urothelial Carcinoma
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Interstate Medical Office
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Sandeep Mashru, MD
Contact Information:
- Rhonda Stephenson, RN
-503-331-6537
-rhonda.stephenson@kpchr.org
-Central Interstate Medical Office


smilelady1
Do you want to receive
Email Alerts?

Sign Up Here!





Regional Research Sites: