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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00836407
First received: February 3, 2009
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention Phase
Pancreatic Cancer
Drug: Ipilimumab
Biological: Pancreatic Cancer Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine if Ipilimumab Alone or in Combination With Pancreatic Tumor Vaccine Has an Acceptable Safety Profile (Less Than 33% Unacceptable Toxicity) in Subjects With Locally Advanced, Unresectable or Metastatic Pancreatic Adenocarcinoma [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Unnacceptable toxicities are defined as drug related > grade 4 AEs or grade 3 AE 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:
  • Overall Survival (OS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To Explore an Association Between Immune-related Adverse Events (IRAEs) and ORR. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To Measure Tumor Marker Kinetics (CA 19-9) in Patients Receiving Treatment. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Ipilimumab Alone
Ipilimumab alone
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.
Other Names:
  • BMS-734016
  • MDX-010
Experimental: Arm 2: Ipilimumab + Pancreatic Cancer Vaccine
Ipilimumab + Pancreatic Cancer Vaccine
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.
Other Names:
  • BMS-734016
  • MDX-010
Biological: 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.
Other Name: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836407

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Dung Le, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00836407     History of Changes
Other Study ID Numbers: J0834, BMS # CA184-081
Study First Received: February 3, 2009
Results First Received: October 16, 2013
Last Updated: October 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
pancreatic cancer
vaccine
immunotherapy
antibody
CTLA-4

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014