Tisch Cancer Institute - BMS Study # CA027-005: Neoadjuvant Nivolumab + BMS-813160 (CCR2/5-inhibitor) or BMS-986253 (Anti-IL-8) for NSCLC or HCC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Significant Tumor Necrosis (STN)
研究概览
简要总结
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:
- 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)
- Improvement in long term survival rates
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Surgical candidate for resection of their tumor
- •Agree to use adequate contraception
- •Adequate organ and marrow function
排除标准
- •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
研究组 & 干预措施
Cohort D
HCC: Nivolumab + BMS-813160
干预措施: Nivolumab (Drug)
Cohort D
HCC: Nivolumab + BMS-813160
干预措施: BMS-813160 (Drug)
Cohort E
HCC: Nivolumab + BMS-986253
干预措施: Nivolumab (Drug)
Cohort E
HCC: Nivolumab + BMS-986253
干预措施: BMS-986253 (Drug)
Cohort A
NSCLC: Nivolumab + BMS-813160
干预措施: BMS-813160 (Drug)
Cohort B
NSCLC: Nivolumab + BMS-986253
干预措施: Nivolumab (Drug)
Cohort B
NSCLC: Nivolumab + BMS-986253
干预措施: BMS-986253 (Drug)
Cohort C
HCC: Nivolumab
干预措施: Nivolumab (Drug)
Cohort A
NSCLC: Nivolumab + BMS-813160
干预措施: Nivolumab (Drug)
结局指标
主要结局
Significant Tumor Necrosis (STN)
时间窗: 2 Years
STN is defined as necrosis of \>70% of tumor base on pathologic analysis of gross tumor resection at time of surgery.
Major Pathologic Response (MPR)
时间窗: 2 Years
MPR is defined as \<10% viable tumor within resection, at time of surgery.
次要结局
- Percent of individuals who experience adverse events(2 Years)
- Time to Surgery(2 Years)
- Overall Survival (OS)(2 Years)
- Percent of individuals who experience radiographic response(2 Years)
- Progression-free survival (PFS)(2 Years)
研究者
Thomas Marron
Assistant Professor
Icahn School of Medicine at Mount Sinai