FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer

Johns Hopkins Medicine

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Adenocarcinoma

Treatments: Drug: FOLFIRINOX; Biological: Vaccine; Drug: Ipilimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01896869

FD-R-004819-01 (Other Grant/Funding Number)

NA_00086350 (Other Identifier)

J13108

Details and patient eligibility

About

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)

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Ipilimumab + Vaccine (Arm A)

Experimental group

Description:

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Treatment:

Drug: Ipilimumab

Biological: Vaccine

FOLFIRINOX (Arm B)

Experimental group

Description:

Administered every 14 days (one cycle)

Treatment:

Drug: FOLFIRINOX