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

Metastatic Pancreatic Adenocarcinoma Clinical Trial

Official title:

A Phase 2, Multicenter Study of FOLFIRINOX Followed by Ipilimumab in Combination With Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine in the Treatment of Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896869
• Other study ID #: J13108
• Secondary ID: NA_00086350FD-R-
• Status: Completed
• Phase: Phase 2
• Start date: November 2013
• Est. completion date: May 3, 2019

Study information

• Verified date: April 2020
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (abbreviated):

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 (abbreviated):

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

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

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.

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall Survival is the time between the date of randomization on study and death.	4 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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