Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Ipilimumab; Pancreatic Cancer Vaccine
Intervention description: Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.; The Pancreatic Cancer Vaccine (5E8 cells) will be administered intradermally at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.
Intervention MeSH terms: Ipilimumab; Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreatic cancer; vaccine; immunotherapy; antibody; CTLA-4

Summary:

      Research Hypothesis: Ipilimumab (an antibody that blocks negative signals to T cells)
      administered alone or in combination with a pancreatic cancer vaccine (allogeneic pancreatic
      tumor cells transfected with a GM-CSF gene), has an acceptable safety profile in subjects
      with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.

      Primary Objective: To determine the safety profile of ipilimumab alone or in combination with
      a pancreatic cancer vaccine in subjects with locally advanced, unresectable or metastatic
      pancreatic adenocarcinoma.

      Secondary Objectives:

        -  To estimate overall survival (OS) which will serve as the primary efficacy signal.

        -  To explore an association of T cell responses and immunological responses with OS in
           patients receiving treatment.

        -  To estimate overall response rate (ORR), immune related best overall response rate
           (irBOR), progression free survival (PFS), and duration of response in patients receiving
           treatment.

        -  To explore an association between immune-related adverse events (IRAEs) and ORR.

        -  To measure tumor marker kinetics (CA 19-9) in patients receiving treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Documented cancer of the pancreas who have failed (or are not candidates for) standard
             therapy

          2. ECOG Performance Status of 0 to 1

          3. Adequate organ function as defined by study-specified laboratory tests

          4. Must use acceptable form of birth control through the study and for 28 days after
             final dose of study drug

          5. Signed informed consent form

          6. Willing and able to comply with study procedures

        Exclusion Criteria:

          1. Currently have or have history of certain study-specified heart, liver, kidney, lung,
             neurological, immune or other medical conditions

          2. Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National
             Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE),
             version 3.0

          3. Systemically active steroids

          4. Another investigational product within 28 days prior to receiving study drug

          5. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring
             within 28 days prior to receiving study drug

          6. Infection with HIV, hepatitis B or C at screening

          7. Pregnant or lactating

          8. Conditions, including alcohol or drug dependence, or intercurrent illness that would
             affect the patient's ability to comply with study visits and procedures