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Completed

NCT Number: NCT01896869

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

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)

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Key information

Conditions

Metastatic Pancreatic Adenocarcinoma Diabetes Mellitus, Insulin-Dependent, 12 Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipilimumab

Drug

3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Other names: MDX-010, BMS-734016

Vaccine

Biological

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)

Folfirinox

Drug

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 outcomes

  1. Overall Survival (OS)

    Time frame: 4 years

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2013
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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