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

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)

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 3, 2019

Interventions

  • Drug: Ipilimumab
    • 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
  • Biological: Vaccine
    • 5×10^8 cells administered in 6 intradermal injections
  • Drug: FOLFIRINOX
    • 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.

Arms, Groups and Cohorts

  • Experimental: Ipilimumab + Vaccine (Arm A)
    • Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
  • Experimental: FOLFIRINOX (Arm B)
    • Administered every 14 days (one cycle)

Clinical Trial Outcome Measures

Primary Measures

  • Overall Survival (OS)
    • Time Frame: 4 years
    • Overall Survival is the time between the date of randomization on study and death.

Secondary Measures

  • Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
    • Time Frame: 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).
  • Progression Free Survival (PFS)
    • Time Frame: 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 Progression Free Survival (irPFS)
    • Time Frame: 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.
  • Objective Response Rate
    • Time Frame: 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).
  • Immune-related Objective Response Rate
    • Time Frame: 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.
  • Duration of Response
    • Time Frame: 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.
  • Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dung Le, M.D., Principal Investigator, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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