Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metast… (NCT00836407) | Clinical Trial Compass
CompletedPhase 1
Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
United States30 participantsStarted 2009-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Percent of Patients Experiencing an Unacceptable Toxicity
Timeframe: 4 years
Trial details
NCT IDNCT00836407
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
. 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