AzaPembro Investigator Initiated Trial

Protocol: 
AAAR3554
Phase: 
II

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)