Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	18 and over	Other	J0834 BMS # CA184-081, NCT00836407

Trial Description

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.

Eligibility Criteria

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 Contact Information

Trial Lead Organizations/Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Dung Le, MD

Principal Investigator

U.S.A.
Maryland
	Baltimore
		Dung Le, MD	Ph: 443-287-0002
			Email: dle@jhmi.edu
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Beth Onners, RN	Ph: 410-502-2800
			Email: onnerbe@jhmi.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00836407
Information obtained from ClinicalTrials.gov on March 18, 2009