Azacitidine and Pembrolizumab in Pancreatic Cancer
Condition: Pancreas Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Pembrolizumab; Azacitidine
Intervention description: Pembrolizumab 200 mg IV every 3 weeks until progression; 50 mg/m2 subcutaneous daily for 5 days every 28 days
Intervention MeSH terms: Pembrolizumab; Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreas; pembrolizumab; azacitidine; metastatic pancreatic cancer; first-line

Summary:

      The purpose of this study is to determine the effectiveness of combining immune therapy,
      pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who
      have advanced pancreatic cancer with disease progression on first-line therapy are usually
      treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy
      regimen and national guidelines recommend chemotherapy or clinical trial participation. In
      this study, all study subjects will receive a combination of immune therapy (every 3 weeks)
      and a hypomethylating agent (every 4 weeks). To date, studies have shown that combining a
      hypomethylating agent with chemotherapy or immune therapy may benefit patients across
      different solid tumor types including pancreatic cancer. Preclinical data in a mouse model of
      pancreatic cancer demonstrates improvement in survival with the combination of a
      hypomethylating agent and immune therapy. However, the use of single agent hypomethylating
      agent or immune therapy has not been shown to be effective in patients with pancreatic
      cancer. The one exception, to date, is the use of immune therapy in those individuals with a
      particular genetic feature known as mismatch repair deficiency and microsatellite
      instability. The combination of immune therapy and a hypomethylating agent has not been
      studied in human subjects and is not approved by the FDA for use in pancreatic cancer.

      This is a non-randomized, single-center, open-label trial of pembrolizumab and azacitidine in
      subjects with locally advanced or metastatic pancreatic adenocarcinoma. Approximately 31
      individuals will be asked to participate in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be willing and able to provide written informed consent for the trial.

          -  Age ≥18 years of age on day of signing informed consent.

          -  Have confirmed diagnosis of pancreatic ductal adenocarcinoma

          -  Have a predicted life expectancy of greater than 3 months.

          -  Have measurable disease based on RECIST 1.1.

          -  Have a performance status of 0 or 1 using the Eastern Cooperative Oncology Group
             (ECOG) Performance Scale within 3 days of first dose of study drug.

          -  Have documented radiographic progression to or documented intolerance of first line
             systemic chemotherapy which included either gemcitabine or Fluorouracil (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:

          -  Is currently participating and receiving study therapy or has participated in a study
             of an investigational agent and received study therapy, or herbal/complementary oral
             or IV medicine within 2 weeks of the first dose of treatment.

          -  Has received chemotherapy or radiotherapy within 14 days of first dose of study
             medication.