Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00836407
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    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.
  • Pancreatic Cancer Vaccine — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2009
Status verified
Feb 2020
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Ipilimumab Alone
    Ipilimumab alone
  • Experimental: Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
    Ipilimumab + Pancreatic Cancer Vaccine

Primary Outcome Measure

Percent of Patients Experiencing an Unacceptable Toxicity [ Time Frame: 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-2410-

Find similar trials in Baltimore, MD

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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