Clinical Trials /

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

NCT04123379

Description:

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

Related Conditions:
  • Hepatocellular Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Nivolumab With CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC)
  • Official Title: Tisch Cancer Institute - BMS Study # CA027-005: Neoadjuvant Nivolumab + BMS-813160 (CCR2/5-inhibitor) or BMS-986253 (Anti-IL-8) for NSCLC or HCC

Clinical Trial IDs

  • ORG STUDY ID: GCO 19-1754
  • NCT ID: NCT04123379

Conditions

  • Non-small Cell Lung Cancer
  • Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
NivolumabCohort A
BMS-813160CCR2/5-inhibitorCohort A
BMS-986253anti-IL-8Cohort B

Purpose

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

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
    

Trial Arms

NameTypeDescriptionInterventions
Cohort AExperimentalNSCLC: Nivolumab + BMS-813160
  • Nivolumab
  • BMS-813160
Cohort BExperimentalNSCLC: Nivolumab + BMS-986253
  • Nivolumab
  • BMS-986253
Cohort CExperimentalHCC: Nivolumab
  • Nivolumab
Cohort DExperimentalHCC: Nivolumab + BMS-813160
  • Nivolumab
  • BMS-813160
Cohort EExperimentalHCC: Nivolumab + BMS-986253
  • Nivolumab
  • BMS-986253

Eligibility Criteria

        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
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:Time to Surgery
Time Frame:2 Years
Safety Issue:
Description:Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection.
Measure:Percent of individuals who experience adverse events
Time Frame:2 Years
Safety Issue:
Description: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.
Measure:Percent of individuals who experience radiographic response
Time Frame:2 Years
Safety Issue:
Description: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.
Measure:Progression-free survival (PFS)
Time Frame:2 Years
Safety Issue:
Description: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.
Measure:Overall Survival (OS)
Time Frame:2 Years
Safety Issue:
Description:Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Icahn School of Medicine at Mount Sinai

Trial Keywords

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

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