Tisch Cancer Institute-BMS Study # CA027-005: Neoadjuvant Nivolumab + BMS-813160 (CCR2/5-inhibitor) or BMS-986253 (anti-IL-8) for NSCLC or HCC
Age: 18 - 99 years
Gender: All
Healthy Subjects: No
Recruitment Status: Recruiting
The purpose of this research study is to study the effect of giving a new cancer medicine before surgery, and after surgery, with the goal of determining if this medicine results in 1) a significant immune response against their tumor (which we will see in the tumor that is taken out at the time of surgery) and 2) improvement in long term survival rates.
Inclusion Criteria
1. Histological diagnosis of NSCLC or HCC
2. Willing and able to provide blood samples
3. Willing and able to undergo leukapheresis upon recovery from surgery
4. Willing and able to have excisional or core needle biopsies
5. At least 18 years of age
6. ECOG 0-1
7. Surgical candidate for resection of their tumor
8. Agree to adequate contraception during study participation and 3 months following
9. Adequate organ and marrow function
Exclusion Criteria
1. Patients who have had chemotherapy or radiotherapy within 4 months prior
2. Patients receiving any other investigational agents
3. Patients with metastatic disease, for whom the intent of surgery would not be curative
4. Uncontrolled intercurrent illness
5. Pregnant or nursing patients
6. Diagnosed with primary immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment
7. Has active autoimmune disease that has required systemic treatment in the past year
8. Has known additional malignancy that is progressing and/or requires active treatment
9. Has history or current evidence of any condition, therapy, or laboratory abnormality that might confound results of the trial
10. HIV positive with detectable viral load
11. Has known active Hepatitis B
12. History of allogeneic hematopoietic cell transplantation or solid organ transplantation
13. Documented allergic or hypersensitivity response to any protein therapeutics
14. Prolonged QRS or QTc