Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins