This pilot and feasibility study studies how well nivolumab and combination chemotherapy work before surgery in treating patients with pancreatic cancer that could possibly be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab in combination with chemotherapy before surgery may work better in treating patients with pancreatic cancer compared to chemotherapy alone.
PRIMARY OBJECTIVES: I. To evaluate development of clinically relevant pancreatic fistula in the post-operative period after neoadjuvant treatment with nivolumab and fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (FOLFIRINOX) (FFX). II. To evaluate pathologic complete response after neoadjuvant nivolumab and FOLFIRINOX (FFX). SECONDARY OBJECTIVES: I. To evaluate early efficacy measured by percent change of CA 19-9 response rate, R0 resection rate, overall response rate (ORR) and disease free survival (DFS). EXPLORATORY OBJECTIVES, OTHER ASSESSMENTS: I. To determine degree of changes in the tumor microenvironment (TME) of nivolumab and modified (m) FFX on cell proliferation and apoptosis. OUTLINE: Patients receive nivolumab intravenously (IV) over 60 minutes on day 1. Patients also receive fluorouracil IV over 10 minutes and over 46 hours, irinotecan hydrochloride IV over 90-120 minutes, leucovorin calcium IV over 120 minutes, and oxaliplatin IV over 120 minutes on days 1 and 15. Treatments repeat every 28 days for 3-6 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients with resectable disease undergo surgery. Within 8-12 weeks after surgery, patients with successful resection may receive 6 additional cycles of fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Undergo surgery
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Clinically relevant pancreatic fistula in the post-operative period after neoadjuvant treatment with nivolumab and fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (FOLFIRINOX) (mFFX) chemotherapy
Descriptive statistics with frequency and proportion will be used.
Time frame: Up to 3 years
Pathologic complete response after nivolumab and mFFX treatment
Descriptive statistics with frequency and proportion will be used.
Time frame: Up to 3 years
Percent change of CA 19-9 response rate
Descriptive statistics with frequency and proportion will be used to analyze the CA19-9 response rate.
Time frame: Baseline up to 3 years
R0 resection rate
Time frame: Up to 3 years
Overall response rate (ORR)
Descriptive statistics with frequency and proportion will be used to analyze ORR.
Time frame: Up to 3 years
Disease free survival (DFS)
Kaplan-Meier methods will be used to analyze DFS with median and 95% confidence interval (CI).
Time frame: Up to 3 years
Incidence of adverse events
Will be categorized and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.3.
Time frame: Up to 28 days after last dose of study drug
Delayed wound healing
Time frame: Up to 3 years
Wound dehiscence
Time frame: Up to 3 years
Wound infection
Time frame: Up to 3 years
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