Phase II Open-Label, Single-Center Study Evaluating Safety and Efficacy of Pembrolizumab Following Induction with the Hypomethylating Agent Azacitidine in Patients with Advanced Pancreatic Cancer After Failure of First-Line Therapy
Are you Eligible? (Inclusion Criteria)
Inclusion Criteria:
- ECOG score of 0-1
- Must have documented radiographic progression to or documented intolerance of first line systemic chemotherapy which included either gemcitabine or 5-FU based regimen (including capecitabine)
- Subjects who have documented disease recurrence within 6 months of completing neoadjuvant or adjuvant chemotherapy for limited disease will be eligible for study. Subjects who recur greater than 6 months after completing adjuvant or neoadjuvant chemotherapy will not be eligible unless they receive additional chemotherapy for advanced disease
Exclusion Criteria:
- Has experienced weight loss >10% over 2 months prior to first dose of study therapy
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose greater than 10mg/day of Prednisone equivalent)
- Clinically relevant ascites at baseline (defined as requiring paracentesis) or with moderate radiographic ascites. A minimal amount of radiographic ascites is allowed
- Known chronic or acute Hepatitis B (e.g., HBsAg reactive) or Hepatitis C infection (e.g., HCV RNA [qualitative] is detected)
- Dual infection with HBV/HCV.
- Antiviral therapy for HBV must be given for at least 3 months, and HBV viral load must be less than 100 IU/mL
- HIV positive
Specialty Area(s)
Pancreas