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Active, not recruitingNCT04123379Updated Sep 25, 2026

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

A Phase 2 interventional study of Nivolumab and BMS-813160 in Non-small Cell Lung Cancer and Hepatocellular Carcinoma, sponsored by Icahn School of Medicine at Mount Sinai. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Treatment

Updated Sep 25, 2026Now Active, not recruitingStudy completion movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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
Read the 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

02

Conditions studied

  • Non-small Cell Lung Cancer
  • Hepatocellular Carcinoma

Keywords

  • Nivolumab
  • CCR2/5-inhibitor
  • anti-IL-8
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 48 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Cohort A

    NSCLC: Nivolumab + BMS-813160

    Drug: Nivolumab · Drug: BMS-813160

  • Experimental
    Cohort B

    NSCLC: Nivolumab + BMS-986253

    Drug: Nivolumab · Drug: BMS-986253

  • Experimental
    Cohort C

    HCC: Nivolumab

    Drug: Nivolumab

  • Experimental
    Cohort D

    HCC: Nivolumab + BMS-813160

    Drug: Nivolumab · Drug: BMS-813160

  • Experimental
    Cohort E

    HCC: Nivolumab + BMS-986253

    Drug: Nivolumab · Drug: BMS-986253

Interventions

  • DrugNivolumab

    q4w, dosed twice before surgery and three times following recovery from surgery by injection

  • DrugBMS-813160

    300mg oral twice a day for 28 days

    Also known as: CCR2/5-inhibitor

  • DrugBMS-986253

    2400mg once by injection

    Also known as: anti-IL-8

06

What researchers measure

Primary outcomes

  1. Major Pathologic Response (MPR)

    MPR is defined as \<10% viable tumor within resection, at time of surgery.

    Time frame: 2 Years

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

07

Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
08

Updates

1 registry update since Sep 25, 2026
Status
Completed→Active, not recruiting
changed Sep 25, 2026
Study completion
Aug 24, 2025→Jul 13, 2028
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Completed→Active, not recruiting
    Study completion Aug 24, 2025→Jul 13, 2028
    + 2 other changes: verification date and secondary outcomes

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04123379
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Bristol-Myers Squibb
Responsible party
Thomas Marron (Assistant Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Oct 10, 2019
Start date
Mar 5, 2020
Primary completion
Aug 24, 2023
Completion
Jul 13, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Thomas Marron, MD PhD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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