NCT00836407

Brief Summary

Research Hypothesis: Ipilimumab (an antibody that blocks negative signals to T cells) administered alone or in combination with a pancreatic cancer vaccine (allogeneic pancreatic tumor cells transfected with a GM-CSF gene), has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma. Primary Objective: To determine the safety profile of ipilimumab alone or in combination with a pancreatic cancer vaccine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma. Secondary Objectives:

  • To estimate overall survival (OS) which will serve as the primary efficacy signal.
  • To explore an association of T cell responses and immunological responses with OS in patients receiving treatment.
  • To estimate overall response rate (ORR), immune related best overall response rate (irBOR), progression free survival (PFS), and duration of response in patients receiving treatment.
  • To explore an association between immune-related adverse events (IRAEs) and ORR.
  • To measure tumor marker kinetics (CA 19-9) in patients receiving treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 pancreatic-cancer

Timeline
Completed

Started Feb 2009

Typical duration for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 10, 2013

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

3.4 years

First QC Date

February 3, 2009

Results QC Date

October 16, 2013

Last Update Submit

February 20, 2020

Conditions

Pancreatic Cancer

Keywords

pancreatic cancervaccineimmunotherapyantibodyCTLA-4

Outcome Measures

Primary Outcomes (1)

  • Percent of Patients Experiencing an Unacceptable Toxicity

    Unacceptable toxicity is defined as drug related \>grade 4 AEs or grade 3 AEs including IRAEs not improving to \< grade 2 under therapy within 2 weeks. In addition, \> grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to \< grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity.

    4 years

Secondary Outcomes (4)

  • Overall Survival (OS)

    4 years

  • Overall Response Rate (ORR)

    6 months

  • Immune Related Best Overall Response Rate (irBOR)

    4 years

  • Progression Free Survival (PFS)

    6 months

Study Arms (2)

Arm 1: Ipilimumab Alone

EXPERIMENTAL

Ipilimumab alone

Drug: Ipilimumab

Arm 2: Ipilimumab + Pancreatic Cancer Vaccine

EXPERIMENTAL

Ipilimumab + Pancreatic Cancer Vaccine

Drug: IpilimumabBiological: Pancreatic Cancer Vaccine

Interventions

IpilimumabDRUG

Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.

Also known as: BMS-734016, MDX-010
Arm 1: Ipilimumab AloneArm 2: Ipilimumab + Pancreatic Cancer Vaccine
Pancreatic Cancer VaccineBIOLOGICAL

The Pancreatic Cancer Vaccine (5E8 cells) will be administered intradermally at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.

Also known as: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine
Arm 2: Ipilimumab + Pancreatic Cancer Vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented cancer of the pancreas who have failed (or are not candidates for) standard therapy
  • ECOG Performance Status of 0 to 1
  • Adequate organ function as defined by study-specified laboratory tests
  • Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
  • Signed informed consent form
  • Willing and able to comply with study procedures

You may not qualify if:

  • Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
  • Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
  • Systemically active steroids
  • Another investigational product within 28 days prior to receiving study drug
  • Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
  • Infection with HIV, hepatitis B or C at screening
  • Pregnant or lactating
  • Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (2)

  • Le DT, Lutz E, Uram JN, Sugar EA, Onners B, Solt S, Zheng L, Diaz LA Jr, Donehower RC, Jaffee EM, Laheru DA. Evaluation of ipilimumab in combination with allogeneic pancreatic tumor cells transfected with a GM-CSF gene in previously treated pancreatic cancer. J Immunother. 2013 Sep;36(7):382-9. doi: 10.1097/CJI.0b013e31829fb7a2.

    PMID: 23924790RESULT

  • Hopkins AC, Yarchoan M, Durham JN, Yusko EC, Rytlewski JA, Robins HS, Laheru DA, Le DT, Lutz ER, Jaffee EM. T cell receptor repertoire features associated with survival in immunotherapy-treated pancreatic ductal adenocarcinoma. JCI Insight. 2018 Jul 12;3(13):e122092. doi: 10.1172/jci.insight.122092.

    PMID: 29997287DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsDiabetes Mellitus, Insulin-Dependent, 12

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Dung Le
Organization
The Sidney Kimmel Comprehensive Cancer Center at Johns
dle@jhmi.edu

Study Officials

  • Dung Le, MD

    The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 24, 2020

Results First Posted

December 10, 2013

Record last verified: 2020-02

Locations

US(1)