Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer

Summary: This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy.
  Half of participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207 (Arm A), while the other half will receive epacadostat/pembrolizumab/CRS-207 (Arm B).
  The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups.


Eligibility: Inclusion Criteria (abbreviated):
  -  Documented adenocarcinoma of the pancreas
  -  Have disease progression after prior chemotherapy for metastatic pancreas cancer (or adjuvant or neoadjuvant if progression occurred within 6 months of completing this regimen)
  -  Presence of at least one measurable lesion
  -  Patient acceptance to have a tumor biopsy of an accessible lesion at 2 time points (baseline and on study)
  -  ECOG performance status of 0 or 1
  -  Life expectancy of greater than 3 months
  -  Adequate organ and marrow function defined by study-specified laboratory tests
  Exclusion Criteria (abbreviated):
  -  Brain metastases
  -  Clinical or radiographic ascites (some trace amount may be allowed)
  -  Rapidly progressing disease
  -  Live vaccine within 30 days of study treatment (flu vaccine allowed)
  -  Surgery within 28 days of study treatment (some exceptions for minor procedures)
  -  Use of an investigational agent or device within 28 days of study treatment.
  -  Chemotherapy, radiation, or biological cancer therapy within 14 days of study treatment.
  -  Prior treatment with anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti PD-L2, or with IDO inhibitor.
  -  Use of growth factors within 14 days of study treatment
  -  Use of any systemic steroids within 14 days of study treatment or other immunosuppressive agents within 7 days of study treatment.
  -  Use of more than 2 g/day of acetaminophen
  -  Use of any UGT1A9 inhibitor
  -  Use of warfarin
  -  Use of MAOIs or drugs with significant MAOI activity within the 21 days of screening
  -  History of Seratonin Syndome
  -  Known allergy to both penicillin and sulfa
  -  Known or suspected hypersensitivity to any monoclonal antibody or any study drug component
  -  Have artificial joints or implants that cannot be easily removed or a history of infection associated with an implant
  -  Significant or malignant pleural effusion
  -  New pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study enrollment
  -  History of autoimmune disease (exceptions for Graves or Hashimoto's disease, vitiligo, and type I diabetes mellitus)
  -  Gastrointestinal condition that may affect drug absorption
  -  Significant heart disease or heart disease requiring antibiotic for prevention of endocarditis
  -  History of abnormal electrocardiogram (ECG) that is deemed meaningful by the investigator
  -  History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis
  -  Pulse oximetry of < 92% on room air or the need for supplemental home oxygen
  -  Infection with HIV, hepatitis B or hepatitis C
  -  Other conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access that would affect the patient's ability to comply with study visits and procedures
  -  Pregnant or breastfeeding women
  -  Unwillingness or inability to follow the study schedule for any reason

Relevance to patient case: not relevant