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

Mount Sinai Health System

Status and phase: Active, not recruiting; Phase 2

Conditions: Non-small Cell Lung Cancer; Hepatocellular Carcinoma

Treatments: Drug: BMS-986253; Drug: BMS-813160; Drug: Nivolumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04123379

GCO 19-1754

Details and patient eligibility

About

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

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 5 patient groups

Cohort A

Experimental group

Description:

NSCLC: Nivolumab + BMS-813160

Treatment:

Drug: Nivolumab

Drug: BMS-813160

Cohort B

Experimental group

Description:

NSCLC: Nivolumab + BMS-986253

Treatment:

Drug: Nivolumab

Drug: BMS-986253

Cohort C

Experimental group

Description:

HCC: Nivolumab

Treatment:

Drug: Nivolumab

Cohort D

Experimental group

Description:

HCC: Nivolumab + BMS-813160

Treatment:

Drug: Nivolumab

Drug: BMS-813160

Cohort E

Experimental group

Description:

HCC: Nivolumab + BMS-986253

Treatment:

Drug: Nivolumab

Drug: BMS-986253