Neoplasms

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Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Vaccines

Immunomodulating Agents

Ipilimumab

Immunoglobulins

Immunologic Factors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.

The Pancreatic Cancer Vaccine (5E8 cells) will be administered intradermally at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.

Pancreatic Cancer Vaccine

Dung Le, MD

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.

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

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

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.

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).

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 (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.

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.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arm 1: Ipilimumab Alone

Arm 2: Ipilimumab + Pancreatic Cancer Vaccine

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Dung Le

Percent of Patients Experiencing an Unacceptable Toxicity

Overall Survival (OS)

Overall Response Rate (ORR)

Immune Related Best Overall Response Rate (irBOR)

Progression Free Survival (PFS)

Drug: Ipilimumab Ipilimumab (10mg/kg) will be administered intravenously at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.

Biological/Vaccine: Pancreatic Cancer Vaccine The Pancreatic Cancer Vaccine (5E8 cells) will be administered intradermally at weeks 1, 4, 7 and 10. Subjects will also be offered maintenance phase dosing every 12 weeks.

Overall Study

Spots Global Cancer Trial Database for pancreatic cancer vaccine