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

Status Completed

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

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT04123379
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 2020
• Completion date: November 16, 2023