The purpose of this research study is to study the effect of giving nivolumab with CCR2/5-inhibitor or anti-IL-8 before surgery, and after surgery, with the goal of determining if this medicine results in: 1. A significant immune response against their tumor (which the study team will see in the tumor that is taken out at the time of surgery) 2. Improvement in long term survival rates
Objectives: Cohorts A,B (NSCLC): Primary Objective: Major Pathologic Response (MPR) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response Cohorts C,D,E (HCC): Primary Objective: Significant tumor necrosis (STN) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response Diagnosis and Main Inclusion Criteria: Patients must have disease deemed resectable before enrollment. Study Product: Nivolumab 480mg (q4w, dosed twice before surgery and three times following recovery from surgery) BMS-813160 (CCR2/5-inhibitor) 300mg oral twice a day for 28 days BMS-986253 (anti-IL-8) 2400mg once
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
q4w, dosed twice before surgery and three times following recovery from surgery by injection
300mg oral twice a day for 28 days
2400mg once by injection
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Major Pathologic Response (MPR)
MPR is defined as \<10% viable tumor within resection, at time of surgery.
Time frame: 2 Years
Significant Tumor Necrosis (STN)
STN is defined as necrosis of \>70% of tumor base on pathologic analysis of gross tumor resection at time of surgery.
Time frame: 2 Years
Time to Surgery
Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection.
Time frame: 2 Years
Percent of individuals who experience adverse events
Safety and Tolerability defined by the percent of individuals who experience adverse events at any point during the neoadjuvant period, or within 30 days following the final dose of nivolumab received.
Time frame: 2 Years
Percent of individuals who experience radiographic response
As per RECIST v1.1 as determined by pre-surgical imaging, following receipt of the neoadjuvant therapy. For NSCLC this will be based on CT imaging, while for HCC this imaging will be based on MRI radiographic post-contract subtraction.
Time frame: 2 Years
Progression-free survival (PFS)
Defined as the time, in days, between treatment initiation and when the patient is found to have recurrent and/or metastatic disease on imaging, or death for any reason.
Time frame: 2 Years
Overall Survival (OS)
Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology.
Time frame: 5 Years
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