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

NCT ID: NCT00836407

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-07-31

Brief 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Ipilimumab Alone

Ipilimumab alone

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

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.

Arm 2: Ipilimumab + Pancreatic Cancer Vaccine

Ipilimumab + Pancreatic Cancer Vaccine

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

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.

Pancreatic Cancer Vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

BMS-734016; MDX-010; PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dung Le, MD

Role: PRINCIPAL_INVESTIGATOR

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

Le DT, Lutz E, Uram JN, Sugar EA, Onners B, Solt S, Zheng L, Diaz LA Jr, Donehower RC, Jaffee EM, Laheru DA. Evaluation of ipilimumab in combination with allogeneic pancreatic tumor cells transfected with a GM-CSF gene in previously treated pancreatic cancer. J Immunother. 2013 Sep;36(7):382-9. doi: 10.1097/CJI.0b013e31829fb7a2.

Reference Type: RESULT

PMID: 23924790 (View on PubMed)

Hopkins AC, Yarchoan M, Durham JN, Yusko EC, Rytlewski JA, Robins HS, Laheru DA, Le DT, Lutz ER, Jaffee EM. T cell receptor repertoire features associated with survival in immunotherapy-treated pancreatic ductal adenocarcinoma. JCI Insight. 2018 Jul 12;3(13):e122092. doi: 10.1172/jci.insight.122092.

Reference Type: DERIVED

PMID: 29997287 (View on PubMed)

Other Identifiers

BMS # CA184-081

Identifier Type: -

Identifier Source: secondary_id

J0834

Identifier Type: -

Identifier Source: org_study_id