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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

Study Description
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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)


Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Drug: Ipilimumab Biological: Vaccine Drug: FOLFIRINOX Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2013
Actual Primary Completion Date : May 3, 2019
Actual Study Completion Date : May 3, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ipilimumab

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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 4 years ]
    Overall Survival is the time between the date of randomization on study and death.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


  4. 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).

  5. 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.


  6. 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.

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896869


Locations
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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Dung Le, M.D. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  Study Documents (Full-Text)

Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Study Protocol and Statistical Analysis Plan  [PDF] February 10, 2017

More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01896869    
Other Study ID Numbers: J13108
NA_00086350 ( Other Identifier: JHMIRB )
FD-R-004819-01 ( Other Grant/Funding Number: FDA OOPD )
First Posted: July 11, 2013    Key Record Dates
Results First Posted: May 6, 2020
Last Update Posted: May 19, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Pancreatic Cancer
Vaccine
Immunotherapy
Ipilimumab
 cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
antibody
FOLFIRINOX
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ipilimumab
 Folfirinox
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action