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Brief Title: Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Official Title: A Phase Ib Trial Evaluating the Safety and Feasibility of Ipilimumab (BMS-734016) Alone or in Combination With Allogeneic Pancreatic Tumor Cells Transfected With a GM-CSF Gene for the Treatment of Locally Advanced, Unresectable or Metastatic Pancreatic Adenocarcinoma
Study ID: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Name: Dung Le, MD
Affiliation: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: PRINCIPAL_INVESTIGATOR