NCT04123379

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

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Non-small Cell Lung Cancer
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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
DRUG	BMS-986253	2400mg once by injection

Timeline

• Start date: 2020-03-05
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-10-10
• Last updated: 2025-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study