Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Phase 1

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Ipilimumab
Biological: Pancreatic Cancer Vaccine

Registration Number: NCT00836407

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Ipilimumab + Pancreatic Cancer Vaccine	Pancreatic Cancer Vaccine	Ipilimumab + Pancreatic Cancer Vaccine
Arm 1: Ipilimumab Alone	Ipilimumab	Ipilimumab alone
Arm 2: Ipilimumab + Pancreatic Cancer Vaccine	Ipilimumab	Ipilimumab + Pancreatic Cancer Vaccine

Primary Outcome Measures

Name	Time	Method
Percent of Patients Experiencing an Unacceptable Toxicity	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 Outcome Measures

Name	Time	Method
Overall Survival (OS)	4 years	OS will be measured from date of randomization until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).
Overall Response Rate (ORR)	6 months	ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) during the first 6 months of treatment. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Immune Related Best Overall Response Rate (irBOR)	4 years	Immune Related Best Overall Response (BOR) is the best response recorded from the start of the study treatment until the disease progression/recurrence based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Estimation based on the Kaplan-Meier curve.
Progression Free Survival (PFS)	6 months	PFS is defined as the number of months from the date of randomization to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.