Neoadjuvant Nivolumab With CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC)

Tisch Cancer Institute - BMS Study # CA027-005: Neoadjuvant Nivolumab + BMS-813160 (CCR2/5-inhibitor) or BMS-986253 (Anti-IL-8) for NSCLC or HCC

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

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma; Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Nivolumab; Drug: BMS-813160; Drug: BMS-986253

Detailed Description

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
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of NSCLC or HCC
• Willing to provide blood samples
• Willing to undergo leukapheresis at Mount Sinai Hospital or New York Blood Bank
• Willing to have excisional or core needle biopsies
• At least 18 years of age
• ECOG 0-1
• Surgical candidate for resection of their tumor
• Agree to use adequate contraception
• Adequate organ and marrow function

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 months for a different primary tumor or patients who have received locoregional therapy for the target lesion
• Patients receiving any other investigational agents
• Patients with metastatic disease for whom the intent of surgery would not be curative
• Uncontrolled intercurrent illness
• Pregnant or nursing
• Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days
• Has active autoimmune disease that has required systemic treatment in the past year
• Has a known additional malignancy that is progressing and/or requires active treatment
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not the in the best interest of the patient to participate
• HIV positive with detectable viral load or anyone not on stable anti-viral regimen
• Has known active Hepatitis B
• History of allogeneic hematopoietic cell transplantation or solid organ transplantation
• Documented allergic or hypersensitivity response to any protein therapeutics
• Patients may not have prolonged QRS or QTc

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A; NSCLC: Nivolumab + BMS-813160	Drug: Nivolumab; q4w, dosed twice before surgery and three times following recovery from surgery by injection; Drug: BMS-813160; 300mg oral twice a day for 28 days; Other Names: CCR2/5-inhibitor
Experimental: Cohort B; NSCLC: Nivolumab + BMS-986253	Drug: Nivolumab; q4w, dosed twice before surgery and three times following recovery from surgery by injection; Drug: BMS-986253; 2400mg once by injection; Other Names: anti-IL-8
Experimental: Cohort C; HCC: Nivolumab	Drug: Nivolumab; q4w, dosed twice before surgery and three times following recovery from surgery by injection
Experimental: Cohort D; HCC: Nivolumab + BMS-813160	Drug: Nivolumab; q4w, dosed twice before surgery and three times following recovery from surgery by injection; Drug: BMS-813160; 300mg oral twice a day for 28 days; Other Names: CCR2/5-inhibitor
Experimental: Cohort E; HCC: Nivolumab + BMS-986253	Drug: Nivolumab; q4w, dosed twice before surgery and three times following recovery from surgery by injection; Drug: BMS-986253; 2400mg once by injection; Other Names: anti-IL-8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Pathologic Response (MPR)	MPR is defined as <10% viable tumor within resection, at time of surgery.	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.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Surgery	Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection.	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.	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.	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.	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.	2 Years

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Thomas Marron, MD PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Actual): August 24, 2023
• Study Completion (Actual): August 24, 2025

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Nivolumab; CCR2/5-inhibitor; anti-IL-8
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Lung Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; HuMax-IL8; BMS-813160
• Other Study ID Numbers: GCO 19-1754

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No