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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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 OOPD

Official Title

A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab in Combination With Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine (GVAX) in the Treatment of Metastatic Pancreatic Cancer

Keywords

Metastatic Pancreatic Adenocarcinoma Pancreatic Cancer Vaccine Immunotherapy Ipilimumab CTLA-4 antibody FOLFIRINOX Vaccines Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

(abbreviated):

  1. Documented adenocarcinoma of the pancreas
  2. Stable metastatic pancreatic cancer after 8-12 doses of FOLFIRINOX
  3. 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%

You CAN'T join if...

(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

Locations

  • Washington University School of Medicine
    Saint Louis, Missouri, 63110, United States
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland, 21205, United States

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
Sidney Kimmel Comprehensive Cancer Center
ID
NCT01896869
Phase
Phase 2
Lead Scientist
Andrew Ko
Study Type
Interventional
Last Updated
July 1, 2017
I’m interested in this study!