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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:November 2013
End Date:January 2021

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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

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


Inclusion Criteria (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%

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
We found this trial at
3
sites
Baltimore, Maryland 21231
410-955-6190
Principal Investigator: Dung Le, M.D.
Phone: 410-955-8804
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
Principal Investigator: Andrew Ko, MD
Phone: 415-353-7286
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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