Lung Cancer Clinical Trial

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

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:

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)
Improvement in long term survival rates

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Full 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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT04123379

Recruitment Status:

Recruiting

Sponsor:

Icahn School of Medicine at Mount Sinai

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There is 1 Location for this study

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Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Ashley Hammad, RN
Contact
212-824-7259
[email protected]
Meredith Legg, NP
Contact
212-241-8335
[email protected]
Thomas Marron, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT04123379

Recruitment Status:

Recruiting

Sponsor:


Icahn School of Medicine at Mount Sinai

How clear is this clinincal trial information?

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