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

Primary Purpose

Non-small Cell Lung Cancer, Hepatocellular Carcinoma

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nivolumab

BMS-813160

BMS-986253

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Nivolumab, CCR2/5-inhibitor, anti-IL-8

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Cohort D

Cohort E

Arm Description

NSCLC: Nivolumab + BMS-813160

NSCLC: Nivolumab + BMS-986253

HCC: Nivolumab

HCC: Nivolumab + BMS-813160

HCC: Nivolumab + BMS-986253

Outcomes

Primary Outcome Measures

Major Pathologic Response (MPR)

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

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.

Secondary Outcome Measures

Time to Surgery

Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection.

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.

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.

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.

Overall Survival (OS)

Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology.

Full Information

NCT ID

NCT04123379

First Posted

October 9, 2019

Last Updated

September 25, 2023

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT04123379

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 5, 2020 (Actual)

Primary Completion Date

August 31, 2023 (Actual)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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: 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) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, Hepatocellular Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A

Arm Type

Experimental

Arm Description

NSCLC: Nivolumab + BMS-813160

Arm Title

Cohort B

Arm Type

Experimental

Arm Description

NSCLC: Nivolumab + BMS-986253

Arm Title

Cohort C

Arm Type

Experimental

Arm Description

HCC: Nivolumab

Arm Title

Cohort D

Arm Type

Experimental

Arm Description

HCC: Nivolumab + BMS-813160

Arm Title

Cohort E

Arm Type

Experimental

Arm Description

HCC: Nivolumab + BMS-986253

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

BMS-813160

Other Intervention Name(s)

CCR2/5-inhibitor

Intervention Description

300mg oral twice a day for 28 days

Intervention Type

Drug

Intervention Name(s)

BMS-986253

Other Intervention Name(s)

anti-IL-8

Intervention Description

2400mg once by injection

Primary Outcome Measure Information:

Title

Major Pathologic Response (MPR)

Description

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

Time Frame

2 Years

Title

Significant Tumor Necrosis (STN)

Description

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 Outcome Measure Information:

Title

Time to Surgery

Description

Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection.

Time Frame

2 Years

Title

Percent of individuals who experience adverse events

Description

Time Frame

2 Years

Title

Percent of individuals who experience radiographic response

Description

Time Frame

2 Years

Title

Progression-free survival (PFS)

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.

Time Frame

2 Years

Title

Overall Survival (OS)

Description

Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology.

Time Frame

2 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Marron, MD PhD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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