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

Non-small Cell Lung Cancer Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT04123379
• Other study ID #: GCO 19-1754
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 2020
• Est. completion date: November 16, 2023

Study information

• Verified date: June 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Carcinoma, Non-Small-Cell Lung
• Hepatocellular Carcinoma
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Nivolumab
q4w, dosed twice before surgery and three times following recovery from surgery by injection
• BMS-813160
300mg oral twice a day for 28 days
• BMS-986253
2400mg once by injection

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Pathologic Response (MPR)	MPR is defined as <10% viable tumor within resection, at time of surgery.	2 Years
Primary	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	Time to Surgery	Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection.	2 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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