Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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:
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | NSCLC: Nivolumab + BMS-813160 |
|
| Cohort B | Experimental | NSCLC: Nivolumab + BMS-986253 |
|
| Cohort C | Experimental | HCC: Nivolumab |
|
| Cohort D | Experimental | HCC: Nivolumab + BMS-813160 |
|
| Cohort E | Experimental | HCC: Nivolumab + BMS-986253 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | q4w, dosed twice before surgery and three times following recovery from surgery by injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Surgery | Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection. | 2 Years |
| Percent of individuals who experience adverse events | Safety and Tolerability defined by the percent of individuals who experience adverse events at any point during the neoadjuvant period, or within 30 days following the final dose of nivolumab received. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Marron, MD PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BMS-813160 | Drug | 300mg oral twice a day for 28 days |
|
|
| BMS-986253 | Drug | 2400mg once by injection |
|
|
| 2 Years |
| Percent of individuals who experience radiographic response | As per RECIST v1.1 as determined by pre-surgical imaging, following receipt of the neoadjuvant therapy. For NSCLC this will be based on CT imaging, while for HCC this imaging will be based on MRI radiographic post-contract subtraction. | 2 Years |
| Progression-free survival (PFS) | Defined as the time, in days, between treatment initiation and when the patient is found to have recurrent and/or metastatic disease on imaging, or death for any reason. | 2 Years |
| Overall Survival (OS) | Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology. | 2 Years |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C570874 | BMS-813160 |
| C000709704 | HuMax-IL8 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided