Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT01896869
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01896869
Study Brief:
Protocol Section:
NCT01896869