Clinical trial NCT04123379: Neoadjuvant Nivolumab with CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC)
Official title: Tisch Cancer Institute - BMS Study # CA027-005: Neoadjuvant Nivolumab + BMS-813160 (CCR2/5-inhibitor) or BMS-986253 (anti-IL-8) for NSCLC or HCC
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Hepatocellular Carcinoma
Keywords: Nivolumab
CCR2/5-inhibitor
anti-IL-8
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2019-10-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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

Detailed 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

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

Primary outcomes:
measure: Major Pathologic Response (MPR)
timeFrame: 2 Years
measure: Significant Tumor Necrosis (STN)
timeFrame: 2 Years
Secondary outcomes:
measure: Time to Surgery
timeFrame: 2 Years
measure: Percent of individuals who experience adverse events
timeFrame: 2 Years
measure: Percent of individuals who experience radiographic response
timeFrame: 2 Years
measure: Progression-free survival (PFS)
timeFrame: 2 Years
measure: Overall Survival (OS)
timeFrame: 2 Years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Thomas Marron, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: