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

NCT01896869 | Completed Phase 2 Results DMC

• 3 other identifiers: J13108NA_00086350FD-R-004819-01
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 3

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

Keywords

Pancreatic Cancer; Vaccine; Immunotherapy; Ipilimumab; cytotoxic T-lymphocyte-associated protein 4 (CTLA-4); antibody; FOLFIRINOX

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall Survival is the time between the date of randomization on study and death.

  4 years

Secondary Outcomes (7)

• Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine

  From the first dose of study drug through 70 days after last dose, up to 13 months

• Progression Free Survival (PFS)

  Up to 4 years

• Immune-related Progression Free Survival (irPFS)

  Up to 4 years

• Objective Response Rate

  Assessed until disease progression, up to 2 years

• Immune-related Objective Response Rate

  Assessed until disease progression, up to 2 years

Study Arms (2)

Ipilimumab + Vaccine (Arm A)

EXPERIMENTAL

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

Drug: Ipilimumab; Biological: Vaccine

FOLFIRINOX (Arm B)

EXPERIMENTAL

Administered every 14 days (one cycle)

Drug: FOLFIRINOX

Interventions

Ipilimumab DRUG

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

Also known as: MDX-010, BMS-734016

Ipilimumab + Vaccine (Arm A)

Vaccine BIOLOGICAL

5x10\^8 cells administered in 6 intradermal injections

Also known as: PANC 6.03 pcDNA-1/GM-Neo and PANC 10.05 pcDNA-1/GM-Neo, Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX)

Ipilimumab + Vaccine (Arm A)

FOLFIRINOX 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.

FOLFIRINOX (Arm B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented adenocarcinoma of the pancreas
• Stable metastatic pancreatic cancer after 8-12 doses of FOLFIRINOX
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy greater than 3 months
• Adequate organ and marrow function defined by study-specified laboratory tests.
• Must use acceptable form of birth control while on study
• Oxygen saturation on room air \>92%

You may not qualify if:

• Surgery within 4 weeks of dosing investigational agent (some exceptions for minor procedures)
• Off FOLFIRINOX treatment for more than 70 days prior to treatment on study
• Prior chemotherapy for metastatic pancreatic cancer (other than FOLFIRINOX or adjuvant therapy).
• History of prior treatment with ipilimumab, anti-PD1 antibody, CD137 agonist, or anti-CD40 antibody
• Received any non-oncology live vaccine therapy up to one month prior to or after any dose of ipilimumab/vaccine
• Receiving any other investigational agents
• Any of the following concomitant therapy: IL-2, interferon, immunosuppressive agents, or chronic use of systemic corticosteroids
• History of symptomatic autoimmune disease or immune impairment. Thyroid disease is allowed.
• Known brain metastasis
• Radiographic ascites that is apparent on physical exam or requiring intervention in the 2 months prior to enrollment
• Uncontrolled intercurrent illness
• Known or suspected hypersensitivity to GM-CSF
• Chronic HIV, Hepatitis B or Hepatitis C
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (3)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

Ipilimumab; Vaccines; folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Dung Le
• Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

dle2@jhmi.edu

443-287-0002

Study Officials

• Dung Le, M.D.

  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: November 1, 2013
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: May 19, 2020
• Results First Posted: May 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)