FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Adenocarcinoma
MeSH terms: Pancreatic Neoplasms
Intervention: Ipilimumab; Vaccine; FOLFIRINOX
Intervention description: 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3); 5x10^8 cells administered in 6 intradermal injections; Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
Intervention MeSH terms: Ipilimumab; Folfirinox; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Cancer; Vaccine; Immunotherapy; Ipilimumab; cytotoxic T-lymphocyte-associated protein 4 (CTLA-4); antibody; FOLFIRINOX

Summary:

      This study will enroll patients who have metastatic pancreatic cancer with stable disease on
      FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between
      patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to
      receive FOLFIRINOX.

      Funding Source - FDA Office of Orphan Product Development (OOPD)
    

Eligibility criteria:

        Inclusion Criteria (abbreviated):

          1. Documented adenocarcinoma of the pancreas

          2. Stable metastatic pancreatic cancer after 8-12 doses of FOLFIRINOX

          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          4. Life expectancy greater than 3 months

          5. Adequate organ and marrow function defined by study-specified laboratory tests.

          6. Must use acceptable form of birth control while on study

          7. Oxygen saturation on room air >92%

        Exclusion Criteria (abbreviated):

          1. Surgery within 4 weeks of dosing investigational agent (some exceptions for minor
             procedures)

          2. Off FOLFIRINOX treatment for more than 70 days prior to treatment on study

          3. Prior chemotherapy for metastatic pancreatic cancer (other than FOLFIRINOX or adjuvant
             therapy).

          4. History of prior treatment with ipilimumab, anti-PD1 antibody, CD137 agonist, or
             anti-CD40 antibody

          5. Received any non-oncology live vaccine therapy up to one month prior to or after any
             dose of ipilimumab/vaccine

          6. Receiving any other investigational agents

          7. Any of the following concomitant therapy: IL-2, interferon, immunosuppressive agents,
             or chronic use of systemic corticosteroids

          8. History of symptomatic autoimmune disease or immune impairment. Thyroid disease is
             allowed.

          9. Known brain metastasis

         10. Radiographic ascites that is apparent on physical exam or requiring intervention in
             the 2 months prior to enrollment

         11. Uncontrolled intercurrent illness

         12. Known or suspected hypersensitivity to GM-CSF

         13. Chronic HIV, Hepatitis B or Hepatitis C

         14. Pregnant or breastfeeding women