We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01896869
Previous Study | Return to List | Next Study

A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab With Allogenic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer

This study has suspended participant recruitment.
(On hold during during interim analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01896869
First Posted: July 11, 2013
Last Update Posted: July 19, 2017
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.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  Purpose

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 OOPD


Condition Intervention Phase
Metastatic Pancreatic Adenocarcinoma Drug: Ipilimumab Biological: Vaccine Drug: FOLFIRINOX Phase 2

Study Type: Interventional
Study Design: 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 (GVAX) in the Treatment of Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 4 years ]
    Comparison of overall survival between patients on Arm A (Vaccine + IPI) and Arm B (FOLFIRINOX)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 92
Study Start Date: November 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab + Vaccine
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
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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. 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
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
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
Investigators
Principal Investigator: Dung Le, M.D. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01896869     History of Changes
Other Study ID Numbers: J13108
NA_00086350 ( Other Identifier: JHMIRB )
FD-R-004819-01 ( Other Grant/Funding Number: FDA OOPD )
First Submitted: July 8, 2013
First Posted: July 11, 2013
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Pancreatic Cancer
Vaccine
Immunotherapy
Ipilimumab
CTLA-4
antibody
FOLFIRINOX

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Vaccines
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs