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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01896869
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : May 6, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE July 8, 2013
First Posted Date  ICMJE July 11, 2013
Results First Submitted Date  ICMJE April 22, 2020
Results First Posted Date  ICMJE May 6, 2020
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
Overall Survival (OS) [ Time Frame: 4 years ]
Overall Survival is the time between the date of randomization on study and death.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
Overall Survival [ Time Frame: 4 years ]
Comparison of overall survival between patients on Arm A (Vaccine + IPI) and Arm B (FOLFIRINOX)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
  • Number of adverse events as a measure of toxicity [ Time Frame: 4 years ]
  • Progression Free Survival (PFS) [ Time Frame: Assessed weeks 1, 10, and 18, then every 8 weeks for up to 4 years ]
    Average time from start of treatment to progression or death, whichever comes first.
  • immune-related Progression Free Survival (irPFS) [ Time Frame: Assessed weeks 1, 10, and 18, then every 8 weeks for up to 4 years ]
    Average time from start of treatment to progression or death, whichever comes first. New lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.
  • Objective Response Rate [ Time Frame: Assessed weeks 1, 10, and 18, then every 8 weeks for up to four years ]
    Evaluation of percentage of patients from each group Achieving a Complete Response (CR) or Partial Response (PR) by RECIST and immune-related response criteria (irRC).
  • Duration of Response [ Time Frame: Assessed weeks 1, 10, and 18, then every 8 weeks for up to four years ]
    Average length of time between achieving a complete response (CR) or partial response (PR)and documentation of recurrent or progressive disease.
  • Tumor Marker (CA19-9) Kinetics [ Time Frame: Assessed every 3-4 weeks for up to four years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Adenocarcinoma
Intervention  ICMJE
  • Drug: Ipilimumab
    3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
    Other Names:
    • MDX-010
    • BMS-734016
  • Biological: Vaccine
    5x10^8 cells administered in 6 intradermal injections
    Other Names:
    • PANC 6.03 pcDNA-1/GM-Neo and PANC 10.05 pcDNA-1/GM-Neo
    • Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX)
  • 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.
Study Arms  ICMJE
  • Experimental: Ipilimumab + Vaccine (Arm A)
    Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
    Interventions:
    • Drug: Ipilimumab
    • Biological: Vaccine
  • Experimental: FOLFIRINOX (Arm B)
    Administered every 14 days (one cycle)
    Intervention: Drug: FOLFIRINOX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)
83
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2013)
92
Actual Study Completion Date  ICMJE May 3, 2019
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01896869
Other Study ID Numbers  ICMJE J13108
NA_00086350 ( Other Identifier: JHMIRB )
FD-R-004819-01 ( Other Grant/Funding Number: FDA OOPD )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dung Le, M.D. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP