Status:
COMPLETED
FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Metastatic Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 receiv...
Eligibility Criteria
Inclusion
- Inclusion Criteria (abbreviated):
- Documented adenocarcinoma of the pancreas
- Stable metastatic pancreatic cancer after 8-12 doses of FOLFIRINOX
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 3 months
- Adequate organ and marrow function defined by study-specified laboratory tests.
- Must use acceptable form of birth control while on study
- Oxygen saturation on room air \>92%
- Exclusion Criteria (abbreviated):
- Surgery within 4 weeks of dosing investigational agent (some exceptions for minor procedures)
- Off FOLFIRINOX treatment for more than 70 days prior to treatment on study
- Prior chemotherapy for metastatic pancreatic cancer (other than FOLFIRINOX or adjuvant therapy).
- History of prior treatment with ipilimumab, anti-PD1 antibody, CD137 agonist, or anti-CD40 antibody
- Received any non-oncology live vaccine therapy up to one month prior to or after any dose of ipilimumab/vaccine
- Receiving any other investigational agents
- Any of the following concomitant therapy: IL-2, interferon, immunosuppressive agents, or chronic use of systemic corticosteroids
- History of symptomatic autoimmune disease or immune impairment. Thyroid disease is allowed.
- Known brain metastasis
- Radiographic ascites that is apparent on physical exam or requiring intervention in the 2 months prior to enrollment
- Uncontrolled intercurrent illness
- Known or suspected hypersensitivity to GM-CSF
- Chronic HIV, Hepatitis B or Hepatitis C
- Pregnant or breastfeeding women
Exclusion
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2019
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01896869
Start Date
November 1 2013
End Date
May 3 2019
Last Update
May 19 2020
Active Locations (3)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
2
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110