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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins83 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Pancreatic Adenocarcinoma

Interventions

IpilimumabDRUG

3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

VaccineBIOLOGICAL

5x10\^8 cells administered in 6 intradermal injections

FOLFIRINOXDRUG

Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Overall Survival (OS)

Overall Survival is the time between the date of randomization on study and death.

Time frame: 4 years

Secondary Outcomes

Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine

Toxicity was assessed as the number of patients experiencing study drug-related adverse events (AEs). Data reported for only study drug-related adverse events (not all adverse events as reported in the adverse events section).

Time frame: From the first dose of study drug through 70 days after last dose, up to 13 months

Progression Free Survival (PFS)

Progression Free Survival is the time from date of randomization to progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan.

Time frame: Up to 4 years

Immune-related Progression Free Survival (irPFS)

Immune-related Progression Free Survival is the median time from date of randomization to disease progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan. Disease progression was evaluated using immune-related Response Criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.

Time frame: Up to 4 years

Objective Response Rate

Objective Response Rate (ORR) is defined as the number of patients from each group achieving a Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria In Solid Tumors (RECIST).

Data from ClinicalTrials.gov

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