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

Johns Hopkins Medicine

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Ipilimumab; Biological: Pancreatic Cancer Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00836407

BMS # CA184-081

J0834

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Documented cancer of the pancreas who have failed (or are not candidates for) standard therapy
2. ECOG Performance Status of 0 to 1
3. Adequate organ function as defined by study-specified laboratory tests
4. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
5. Signed informed consent form
6. Willing and able to comply with study procedures

Exclusion criteria

1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
2. 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
3. Systemically active steroids
4. Another investigational product within 28 days prior to receiving study drug
5. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
6. Infection with HIV, hepatitis B or C at screening
7. Pregnant or lactating
8. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arm 1: Ipilimumab Alone

Experimental group

Description:

Ipilimumab alone

Treatment:

Drug: Ipilimumab

Arm 2: Ipilimumab + Pancreatic Cancer Vaccine

Experimental group

Description:

Ipilimumab + Pancreatic Cancer Vaccine

Treatment:

Biological: Pancreatic Cancer Vaccine

Drug: Ipilimumab