FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Interventions
- Registration Number
- NCT01896869
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FOLFIRINOX (Arm B) FOLFIRINOX Administered every 14 days (one cycle) Ipilimumab + Vaccine (Arm A) Vaccine Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks. Ipilimumab + Vaccine (Arm A) Ipilimumab Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 4 years Overall Survival is the time between the date of randomization on study and death.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to 4 years 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.
Immune-related Objective Response Rate Assessed until disease progression, up to 2 years Immune-related Objective Response Rate (irORR) is measured the same way, except that tumor responses are 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.Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels Baseline, Week 7, and Week 10 visits Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0-36 U/mL.
Objective Response Rate Assessed until disease progression, up to 2 years 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).
Duration of Response Up to 22 months Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease.
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine From the first dose of study drug through 70 days after last dose, up to 13 months 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).
Immune-related Progression Free Survival (irPFS) Up to 4 years 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.
Trial Locations
- 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
🇺🇸Saint Louis, Missouri, United States