FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer

NCT ID: NCT01896869

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2019-05-03

Brief Summary

This study will enroll patients who have metastatic pancreatic cancer with stable disease on FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to receive FOLFIRINOX.

Funding Source - FDA Office of Orphan Product Development (OOPD)

Conditions

Metastatic Pancreatic Adenocarcinoma

Study Design

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

Study Groups

Ipilimumab + Vaccine (Arm A)

Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Vaccine

Intervention Type: BIOLOGICAL

5x10\^8 cells administered in 6 intradermal injections

FOLFIRINOX (Arm B)

Administered every 14 days (one cycle)

Group Type: EXPERIMENTAL

FOLFIRINOX

Intervention Type: DRUG

Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Interventions

Ipilimumab

3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)

Intervention Type: DRUG

Vaccine

5x10\^8 cells administered in 6 intradermal injections

Intervention Type: BIOLOGICAL

FOLFIRINOX

Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.

Intervention Type: DRUG

Other Intervention Names

MDX-010; BMS-734016; PANC 6.03 pcDNA-1/GM-Neo and PANC 10.05 pcDNA-1/GM-Neo; Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX)

Eligibility Criteria

Inclusion Criteria

1. Documented adenocarcinoma of the pancreas

2. Stable metastatic pancreatic cancer after 8-12 doses of FOLFIRINOX

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

4. Life expectancy greater than 3 months

5. Adequate organ and marrow function defined by study-specified laboratory tests.

6. Must use acceptable form of birth control while on study

7. Oxygen saturation on room air >92%

Exclusion Criteria

1. Surgery within 4 weeks of dosing investigational agent (some exceptions for minor procedures)

2. Off FOLFIRINOX treatment for more than 70 days prior to treatment on study

3. Prior chemotherapy for metastatic pancreatic cancer (other than FOLFIRINOX or adjuvant therapy).

4. History of prior treatment with ipilimumab, anti-PD1 antibody, CD137 agonist, or anti-CD40 antibody

5. Received any non-oncology live vaccine therapy up to one month prior to or after any dose of ipilimumab/vaccine

6. Receiving any other investigational agents

7. Any of the following concomitant therapy: IL-2, interferon, immunosuppressive agents, or chronic use of systemic corticosteroids

8. History of symptomatic autoimmune disease or immune impairment. Thyroid disease is allowed.

9. Known brain metastasis

10. Radiographic ascites that is apparent on physical exam or requiring intervention in the 2 months prior to enrollment

11. Uncontrolled intercurrent illness

12. Known or suspected hypersensitivity to GM-CSF

13. Chronic HIV, Hepatitis B or Hepatitis C

14. Pregnant or breastfeeding women

• 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, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NA_00086350

Identifier Type: OTHER

Identifier Source: secondary_id

FD-R-004819-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

J13108

Identifier Type: -

Identifier Source: org_study_id