The purpose of this study is to evaluate if the combination of nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with GVAX is safe in patients with locally advanced pancreatic cancer (LAPC) who have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
SBRT (6.6 Gy over 5 days) will be administered between 2 to 4 weeks after chemotherapy. (Prior to surgery)
Nivolumab (480 mg) will be administered IV over 30 minutes, on day 1 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery Nivolumab will be given on Day 1 of cycles 2-5. Cycles are 4 weeks long.
CCR2/CCR5 dual antagonist (150 mg capsules) will be administered orally twice a day, on days 1-28 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery CCR2/CCR5 dual antagonist will be given daily on cycles 2-5. Cycles are 4 weeks long.
Vaccine (5x10\^8 cells) will be administered on day 2 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery GVAX will be given on Day 2 of cycles 2-5. Cycles are 4 weeks long. Six intradermal injections every 4 weeks.
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Number of Participants experiencing study drug-related toxicities
Number of participants who experienced study drug-related toxicities as defined by CTCAE v5.0
Time frame: 3 years
Percentage of participants treated with immunotherapy who achieve an immune response
Percentage of participants who have \>80% increase of infiltration of CD8+CD137+ T cells into the pancreatic ductal adenocarcinoma after treatment with immunotherapy compared to baseline before treatment.
Time frame: 3 years
Overall survival (OS)
Number of months from the time of Cycle 1, Day 1 of immunotherapy until death from any cause
Time frame: 3 years
Metastasis free survival (MFS)
Number of months from the time of Cycle 1, Day 1 of immunotherapy until first documented distant metastases on imaging per RECIST 1.1 or death from any cause, whichever occurs first.
Time frame: 3 years
Local progression free survival (LPFS) Time
Number of months from the time of Cycle 1, Day 1 of immunotherapy until first documented local progression or relapse from complete response on imaging (using RECIST 1.1 criteria and irRECIST criteria) or death from any cause, whichever occurs first.
Time frame: 3 years
Surgical Resectability Rate
Number of participants who are able to undergo successful tumor resection (as defined by R0 and R1 resection).
Time frame: 3 years
Pathological Response Rate
Number of participants who have a pathologic complete response as determined by surgical margins and residual disease.
Time frame: 3 years
Change in Quality of life score based on EORTC QLQ-C30/Pan26
Change in quality of life from baseline will be evaluated using the European Organization for Research and Treatment of Cancer core questionnaire, pancreatic cancer module (EORTC QLQ-C30/Pan26). The QLQ-C30 includes 30 questions assessing global health status/quality of life, function, and symptoms. The PAN26 module comprises of an additional 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes). The score for each item ranges from 0-100, with a higher score reflecting a better level of functioning, a better quality of life, or a worse level of symptoms.
Time frame: Baseline, 3 years
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