NCT04658147进行中（未招募）1 期
Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins4 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年5月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Number of patients who complete pre-op treatment and proceed to surgery
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of neoadjuvant/adjuvant Nivolumab or Nivolumab plus Relatlimab in patients with HCC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Technically resectable HCC as defined by:
- •HCC may be diagnosed pathologically, or noninvasively by the American Association for the Study of Liver Diseases (AASLD) criteria or the Organ Procurement and Transplant Network (OPTN) Obligatory Diagnostic Criteria for Hepatocellular Carcinoma (HCC).
- •No extrahepatic spread, no nodal disease, and no bilateral left and right branch portal vein involvement.
- •Measurable disease per RECIST 1.1 as determined by the investigator.
- •Age ≥ 18 years old on the day of consent.
- •ECOG performance status ≤1 or Karnofsky ≥
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
- •Patients must have adequate liver remnant and function.
- •Antiviral therapy per local standard of care for hepatitis B.
- •LVEF assessment with documented LVEF ≥ 50% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.
- •Woman of child-bearing potential must have a negative pregnancy test.
- •Must use acceptable form of birth control while on study.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Fibrolamellar carcinoma or mixed HCC.
- •Receiving, or previously received, any systemic chemotherapy, or investigational agent for HCC.
- •Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies.
- •Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial.
- •History of HIV infection.
- •Active co-infection with HBV and HDV.
- •Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy.
- •Prior tissue or organ allograft or allogeneic bone marrow transplantation.
- •History of any autoimmune disease requiring systemic treatment within the past 2 years.
- •Systemic or topical corticosteroids at immunosuppressive doses (> 10 mg/day of prednisone or equivalent).
- •Confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
- •Uncontrolled intercurrent illness.•
- •Uncontrolled or significant cardiovascular disease.
- •Significant heart disease.
- •Moderate or severe ascites.
- •Known or suspected hypersensitivity to study treatment.
- •Are pregnant or breastfeeding.
- •WOCBP and men with female partners (WOCBP) who are not willing to use contraception.
- •Unable to have blood drawn.
- •Any other sound medical, psychiatric, and/or social reason as determined by the Investigator.
- •Any illicit drugs or other substance abuse.
研究组 & 干预措施
Arm B - Nivolumab and Relatlimab
Experimental
Participants receive Nivolumab and Relatlimab.
干预措施: Relatlimab (Drug)
Arm A - Nivolumab
Experimental
Participants receive Nivolumab only.
干预措施: Nivolumab (Drug)
Arm B - Nivolumab and Relatlimab
Experimental
Participants receive Nivolumab and Relatlimab.
干预措施: Nivolumab (Drug)
结局指标
主要结局
Number of patients who complete pre-op treatment and proceed to surgery
时间窗: 4 years
次要结局
- Percentage of participants who obtain R0 resection(8 weeks)
- Overall survival (OS) at 12 months(12 months)
- Overall survival (OS) at 18 months(18 months)
- Disease free survival (DFS) at 12 months(12 months)
- Disease free survival (DFS) at 3 years(3 years)
- Number of participants experiencing study drug-related toxicities(4 years)
- Percentage of evaluable patients who obtain a pathologic complete response (pCR) or major pathologic response (MPR)(8 weeks)
- Objective response rate (ORR) at 8 weeks(8 weeks)
- Overall survival (OS) at 3 years(3 years)
- Overall survival (OS) at 5 years(5 years)
- Disease free survival (DFS) at 18 months(18 months)
- Disease free survival (DFS) at 5 years(5 years)
研究者
研究点 (4)
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