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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Bristol-Myers Squibb
• Treatments: Nivolumab

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