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
Overview
- Phase
- Phase 1
- Intervention
- Ipilimumab
- Conditions
- Pancreatic Cancer
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Percent of Patients Experiencing an Unacceptable Toxicity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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
Arms & Interventions
Arm 1: Ipilimumab Alone
Ipilimumab alone
Intervention: Ipilimumab
Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Ipilimumab + Pancreatic Cancer Vaccine
Intervention: Ipilimumab
Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Ipilimumab + Pancreatic Cancer Vaccine
Intervention: Pancreatic Cancer Vaccine
Outcomes
Primary Outcomes
Percent of Patients Experiencing an Unacceptable Toxicity
Time Frame: 4 years
Unacceptable toxicity is defined as drug related \>grade 4 AEs or grade 3 AEs including IRAEs not improving to \< grade 2 under therapy within 2 weeks. In addition, \> grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to \< grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity.
Secondary Outcomes
- Overall Survival (OS)(4 years)
- Overall Response Rate (ORR)(6 months)
- Immune Related Best Overall Response Rate (irBOR)(4 years)
- Progression Free Survival (PFS)(6 months)