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

NCT04123379 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GCO 19-1754
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Improvement in long term survival rates

Conditions

Non-small Cell Lung Cancer; Hepatocellular Carcinoma

Keywords

Nivolumab; CCR2/5-inhibitor; anti-IL-8

Outcome Measures

Primary Outcomes (2)

• Major Pathologic Response (MPR)

  MPR is defined as \<10% viable tumor within resection, at time of surgery.

  2 Years

• 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 Outcomes (5)

• Time to Surgery

  2 Years

• Percent of individuals who experience adverse events

  2 Years

• Percent of individuals who experience radiographic response

  2 Years

• Progression-free survival (PFS)

  2 Years

• Overall Survival (OS)

  2 Years

Study Arms (5)

Cohort A

EXPERIMENTAL

NSCLC: Nivolumab + BMS-813160

Drug: Nivolumab; Drug: BMS-813160

Cohort B

EXPERIMENTAL

NSCLC: Nivolumab + BMS-986253

Drug: Nivolumab; Drug: BMS-986253

Cohort C

EXPERIMENTAL

HCC: Nivolumab

Drug: Nivolumab

Cohort D

EXPERIMENTAL

HCC: Nivolumab + BMS-813160

Drug: Nivolumab; Drug: BMS-813160

Cohort E

EXPERIMENTAL

HCC: Nivolumab + BMS-986253

Drug: Nivolumab; Drug: BMS-986253

Interventions

Nivolumab DRUG

q4w, dosed twice before surgery and three times following recovery from surgery by injection

Cohort A; Cohort B; Cohort C; Cohort D; Cohort E

BMS-813160 DRUG

300mg oral twice a day for 28 days

Also known as: CCR2/5-inhibitor

Cohort A; Cohort D

BMS-986253 DRUG

2400mg once by injection

Also known as: anti-IL-8

Cohort B; Cohort E

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Hepatocellular

Interventions

Nivolumab; BMS-813160; HuMax-IL8

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas Marron, MD PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: March 5, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 17, 2025

Record last verified: 2024-11

Locations

US (1)