Phase 2
N=83
FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
Metastatic Pancreatic Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01896869 ↗Enrolled (actual)
83
Serious AEs
51.3%
Results posted
May 2020
Primary outcome: Primary: Overall Survival (OS) — 9.38; 14.7 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ipilimumab (Drug); Vaccine (Biological); FOLFIRINOX (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
9.38; 14.7 | — |
| SECONDARY Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine |
13; 25; 0; 1; 0; 1 | — |
| SECONDARY Progression Free Survival (PFS) |
2.40; 5.55 | — |
| SECONDARY Immune-related Progression Free Survival (irPFS) |
2.50; 5.55 | — |
| SECONDARY Objective Response Rate |
1; 3 | — |
| SECONDARY Immune-related Objective Response Rate |
2; 4 | — |
| SECONDARY Duration of Response |
2.5; 8.49 | — |
| SECONDARY Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels |
185.0; 85.0; 189.2; 77.9; 237.1; 66.8 | — |
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 Office of Orphan Product Development (OOPD)
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01896869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.