Nivolumab + CCR2/5-inhibitor/Anti-IL-8 for Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Thomas Marron, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Icahn School of Medicine at Mount Sinai

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Thomas Marron, MD PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults with operable lung or liver cancer (NSCLC or HCC) who have functioning organs and marrow. They must agree to use birth control, provide blood samples, undergo leukapheresis at specified locations, and have biopsies. Excluded are those on other trials, with uncontrolled illness, recent chemo/radiotherapy for another tumor, metastatic disease not curable by surgery, pregnant/nursing women, certain immune conditions including active autoimmune diseases treated within a year or current immunosuppressives.

Inclusion Criteria

I have been diagnosed with non-small cell lung cancer or liver cancer.

My organs and bone marrow are working well.

I am willing to have a leukapheresis procedure at Mount Sinai Hospital or New York Blood Bank.

Exclusion Criteria

You have had an allergic reaction to any protein-based treatments in the past.

I have been treated for an autoimmune disease in the last year.

I have active Hepatitis B.

Treatment Details

Interventions

• BMS-813160 (CCR2/5-inhibitor)
• BMS-986253 (Anti-IL-8)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview The study tests the effect of Nivolumab combined with either CCR2/5-inhibitor (BMS-813160) or anti-IL-8 (BMS-986253) before and after surgery in NSCLC/HCC patients. It aims to see if these drugs boost immune response against tumors seen during surgery and improve survival rates.

Participant Groups

Group I: Cohort E Experimental Treatment 2 Interventions

HCC: Nivolumab + BMS-986253

Group II: Cohort D Experimental Treatment 2 Interventions

HCC: Nivolumab + BMS-813160

Group III: Cohort C Experimental Treatment 1 Intervention

HCC: Nivolumab

Group IV: Cohort B Experimental Treatment 2 Interventions

NSCLC: Nivolumab + BMS-986253

Group V: Cohort A Experimental Treatment 2 Interventions

NSCLC: Nivolumab + BMS-813160

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania