FOLFIRINOX Followed By Ipilimumab With Pancreatic Tumor Vaccine In Treatment Of Metastatic Pancreatic Cancer

Study Overview

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

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)

N/A

Metastatic Pancreatic Adenocarcinoma

DRUG: Ipilimumab
BIOLOGICAL: Vaccine
DRUG: FOLFIRINOX

J13108
NA_00086350 (OTHER Identifier) (OTHER: JHMIRB)
FD-R-004819-01 (OTHER_GRANT Identifier) (OTHER_GRANT: FDA OOPD)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-07-08	Results First Submitted 2020-04-22	Last Update Submitted that met QC Criteria 2020-05-05
First Submitted that Met QC Criteria 2013-07-08	Results First Submitted that Met QC Criteria 2020-04-22	Last Update Posted (ACTUAL) 2020-05-19
First Posted (ACTUAL) 2013-07-11	Results First Posted 2020-05-06	Last Verified 2020-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ipilimumab + Vaccine (Arm A) Ipilimumab and vaccine will be administered every 3 weeks for 4 doses, then every 8 weeks.	DRUG: Ipilimumab 3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3) BIOLOGICAL: Vaccine 5x10^8 cells administered in 6 intradermal injections
EXPERIMENTAL: FOLFIRINOX (Arm B) Administered every 14 days (one cycle)	DRUG: 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Ipilimumab + Vaccine (Arm A)

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

DRUG: Ipilimumab

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

BIOLOGICAL: Vaccine

5x10^8 cells administered in 6 intradermal injections

EXPERIMENTAL: FOLFIRINOX (Arm B)

Administered every 14 days (one cycle)

DRUG: 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.

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival (OS)	Overall Survival is the time between the date of randomization on study and death.	4 years

Secondary Outcome Measures	Measure Description	Time Frame
Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine	Toxicity was assessed as the number of patients experiencing study drug-related adverse events (AEs). Data reported for only study drug-related adverse events (not all adverse events as reported in the adverse events section).	From the first dose of study drug through 70 days after last dose, up to 13 months
Progression Free Survival (PFS)	Progression Free Survival is the time from date of randomization to progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan.	Up to 4 years
Immune-related Progression Free Survival (irPFS)	Immune-related Progression Free Survival is the median time from date of randomization to disease progression or death, whichever comes first. Individuals without follow-up scans were censored one day after randomization and individuals with follow-up scans who did not have disease progression were censored at date of last scan. Disease progression was evaluated using immune-related Response Criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.	Up to 4 years
Objective Response Rate	Objective Response Rate (ORR) is defined as the number of patients from each group achieving a Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria In Solid Tumors (RECIST).	Assessed until disease progression, up to 2 years
Immune-related Objective Response Rate	Immune-related Objective Response Rate (irORR) is measured the same way, except that tumor responses are evaluated using immune-related response criteria (irRC). irRC differs from RECIST primarily in that target lesions are measured in 2 dimensions and new lesions contribute to tumor burden, but do not by themselves qualify as progressive disease.	Assessed until disease progression, up to 2 years
Duration of Response	Average length of time between achieving a complete response (CR) or partial response (PR) and documentation of recurrent or progressive disease.	Up to 22 months
Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels	Carbohydrate Antigen 19-9 (CA19-9) is a tumor marker measured in the blood of patients with pancreas cancer. Not all patients with pancreas cancer will have elevated CA19-9 and there are some conditions other than cancer that can cause an elevated CA19-9. Normal CA19-9 range is 0-36 U/mL.	Baseline, Week 7, and Week 10 visits

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Dung Le, M.D., The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record