Clinical trial NCT01896869: FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
Official title: A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab in Combination With Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Adenocarcinoma
Keywords: Pancreatic Cancer
Vaccine
Immunotherapy
Ipilimumab
cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
antibody
FOLFIRINOX
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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):

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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 4 years
Secondary outcomes:
measure: Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
timeFrame: From the first dose of study drug through 70 days after last dose, up to 13 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 4 years
measure: Immune-related Progression Free Survival (irPFS)
timeFrame: Up to 4 years
measure: Objective Response Rate
timeFrame: Assessed until disease progression, up to 2 years
measure: Immune-related Objective Response Rate
timeFrame: Assessed until disease progression, up to 2 years
measure: Duration of Response
timeFrame: Up to 22 months
measure: Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels
timeFrame: Baseline, Week 7, and Week 10 visits
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Dung Le, M.D.
role: PRINCIPAL_INVESTIGATOR
References: