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Metastatic Pancreatic AdenocarcinomaPhase 2NCT01896869

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

A Phase 2 study testing Ipilimumab, Vaccine and FOLFIRINOX in people with Metastatic Pancreatic Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Adenocarcinoma
What is being tested?
Ipilimumab, Vaccine and FOLFIRINOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
3 sitesUnited States
Study dates
Nov 2013to 3 May 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21205

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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)

Being tested
Ipilimumab, Vaccine, FOLFIRINOX
Keywords
Pancreatic Cancer, Vaccine, Immunotherapy, Ipilimumab, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), antibody, FOLFIRINOX
Medical subject headings
Pancreatic Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IpilimumabDrug

    Also called MDX-010, BMS-734016

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

  • VaccineBiological

    Also called PANC 6.03 pcDNA-1/GM-Neo and PANC 10.05 pcDNA-1/GM-Neo, Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX)

    5x10^8 cells administered in 6 intradermal injections

  • FOLFIRINOXDrug

    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 groups in NCT01896869
Study groupRoleWhat they receive
Ipilimumab + Vaccine (Arm A)ExperimentalIpilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.
Receives: Drug: Ipilimumab; Biological: Vaccine
FOLFIRINOX (Arm B)ExperimentalAdministered every 14 days (one cycle)
Receives: Drug: FOLFIRINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

    Measured: 4 years

Secondary outcomes (7)

  1. 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).

    Measured: From the first dose of study drug through 70 days after last dose, up to 13 months

  2. 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.

    Measured: Up to 4 years

  3. 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.

    Measured: Up to 4 years

  4. 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).

    Measured: Assessed until disease progression, up to 2 years

  5. 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.

    Measured: Assessed until disease progression, up to 2 years

  6. Duration of Response

    Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease.

    Measured: Up to 22 months

  7. 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.

    Measured: Baseline, Week 7, and Week 10 visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2013 (estimated)
  2. Study startNov 2013
  3. Primary completion3 May 2019
  4. Study completion3 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01896869
Sponsor's protocol ID
J13108
Other IDs
NA_00086350, FD-R-004819-01
Status last verified
Apr 2020
First submitted
8 Jul 2013
Last updated
19 May 2020
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ipilimumab, Vaccine and FOLFIRINOX in people with Metastatic Pancreatic Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01896869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.

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