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

Primary Purpose

Metastatic Pancreatic Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ipilimumab
Vaccine
FOLFIRINOX
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma focused on measuring Pancreatic Cancer, Vaccine, Immunotherapy, Ipilimumab, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), antibody, FOLFIRINOX

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ipilimumab + Vaccine (Arm A)

FOLFIRINOX (Arm B)

Arm Description

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Administered every 14 days (one cycle)

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Overall Survival is the time between the date of randomization on study and death.

Secondary Outcome Measures

Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
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)
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)
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
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
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
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
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.

Full Information

First Posted
July 8, 2013
Last Updated
May 5, 2020
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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1. Study Identification

Unique Protocol Identification Number
NCT01896869
Brief Title
FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
May 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Adenocarcinoma
Keywords
Pancreatic Cancer, Vaccine, Immunotherapy, Ipilimumab, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), antibody, FOLFIRINOX

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipilimumab + Vaccine (Arm A)
Arm Type
Experimental
Arm Description
Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Arm Title
FOLFIRINOX (Arm B)
Arm Type
Experimental
Arm Description
Administered every 14 days (one cycle)
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
MDX-010, BMS-734016
Intervention Description
3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
Intervention Type
Biological
Intervention Name(s)
Vaccine
Other Intervention Name(s)
PANC 6.03 pcDNA-1/GM-Neo and PANC 10.05 pcDNA-1/GM-Neo, Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX)
Intervention Description
5x10^8 cells administered in 6 intradermal injections
Intervention Type
Drug
Intervention Name(s)
FOLFIRINOX
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival is the time between the date of randomization on study and death.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine
Description
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).
Time Frame
From the first dose of study drug through 70 days after last dose, up to 13 months
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Up to 4 years
Title
Immune-related Progression Free Survival (irPFS)
Description
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.
Time Frame
Up to 4 years
Title
Objective Response Rate
Description
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).
Time Frame
Assessed until disease progression, up to 2 years
Title
Immune-related Objective Response Rate
Description
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.
Time Frame
Assessed until disease progression, up to 2 years
Title
Duration of Response
Description
Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease.
Time Frame
Up to 22 months
Title
Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels
Description
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.
Time Frame
Baseline, Week 7, and Week 10 visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (abbreviated): Documented adenocarcinoma of the pancreas Stable metastatic pancreatic cancer after 8-12 doses of FOLFIRINOX Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy greater than 3 months Adequate organ and marrow function defined by study-specified laboratory tests. Must use acceptable form of birth control while on study Oxygen saturation on room air >92% Exclusion Criteria (abbreviated): Surgery within 4 weeks of dosing investigational agent (some exceptions for minor procedures) Off FOLFIRINOX treatment for more than 70 days prior to treatment on study Prior chemotherapy for metastatic pancreatic cancer (other than FOLFIRINOX or adjuvant therapy). History of prior treatment with ipilimumab, anti-PD1 antibody, CD137 agonist, or anti-CD40 antibody Received any non-oncology live vaccine therapy up to one month prior to or after any dose of ipilimumab/vaccine Receiving any other investigational agents Any of the following concomitant therapy: IL-2, interferon, immunosuppressive agents, or chronic use of systemic corticosteroids History of symptomatic autoimmune disease or immune impairment. Thyroid disease is allowed. Known brain metastasis Radiographic ascites that is apparent on physical exam or requiring intervention in the 2 months prior to enrollment Uncontrolled intercurrent illness Known or suspected hypersensitivity to GM-CSF Chronic HIV, Hepatitis B or Hepatitis C Pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dung Le, M.D.
Organizational Affiliation
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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