We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123379
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : November 9, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Thomas Marron, Icahn School of Medicine at Mount Sinai

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Hepatocellular Carcinoma Drug: Nivolumab Drug: BMS-813160 Drug: BMS-986253 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 19, 2020
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: 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 Name: 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 Name: anti-IL-8


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Major Pathologic Response (MPR) [ Time Frame: 2 Years ]
    MPR is defined as <10% viable tumor within resection, at time of surgery.

  2. Significant Tumor Necrosis (STN) [ Time Frame: 2 Years ]
    STN is defined as necrosis of >70% of tumor base on pathologic analysis of gross tumor resection at time of surgery.


Secondary Outcome Measures :
  1. Time to Surgery [ Time Frame: 2 Years ]
    Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection.

  2. Percent of individuals who experience adverse events [ Time Frame: 2 Years ]
    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.

  3. Percent of individuals who experience radiographic response [ Time Frame: 2 Years ]
    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.

  4. Progression-free survival (PFS) [ Time Frame: 2 Years ]
    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.

  5. Overall Survival (OS) [ Time Frame: 2 Years ]
    Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123379


Contacts
Layout table for location contacts
Contact: Thomas Marron, MD PhD (212) 824-9472 thomas.marron@mssm.edu

Locations
Layout table for location information
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Thomas Marron, MD PhD    212-824-9472    thomas.marron@mssm.edu   
Principal Investigator: Thomas Marron, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Principal Investigator: Thomas Marron, MD PhD Icahn School of Medicine at Mount Sinai
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Thomas Marron, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04123379    
Other Study ID Numbers: GCO 19-1754
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Marron, Icahn School of Medicine at Mount Sinai:
Nivolumab
CCR2/5-inhibitor
anti-IL-8
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action