Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Completed · Phase 1
Conditions studied: Pancreatic Cancer
In brief
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 facts
- Study ID
- NCT00836407
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 30
- Starts
- 2009-02-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2020-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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