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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety profile of ipilimumab alone or in combination with allogeneic pancreatic tumor cells transfected with a GM-CSF gene in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.

Outcome Time Frame:

Continuous

Safety Issue:

Yes

Principal Investigator

Dung Le, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Authority:

United States: Food and Drug Administration

Study ID:

J0834

NCT ID:

NCT00836407

Start Date:

February 2009

Completion Date:

July 2012

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • vaccine
  • immunotherapy
  • antibody
  • CTLA-4
  • Pancreatic Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410