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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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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

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Non-small Cell Lung Cancer Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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Nivolumab

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

Intervention Type DRUG

BMS-813160

300mg oral twice a day for 28 days

Intervention Type DRUG

BMS-986253

2400mg once by injection

Intervention Type DRUG

Other Intervention Names

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CCR2/5-inhibitor anti-IL-8

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No