NCT03607890进行中（未招募）2 期
Phase 2 Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins4 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2018年11月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with microsatellite instability high (MSI-H) solid tumors refractory to prior PD-(L)1 therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.
- •Patients must have received prior PD-1/PD-L1 inhibitor therapy
- •Patients with the presence of at least one measurable lesion.
- •Life expectancy of greater than 3 months.
- •Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
- •Documented left ventricular ejection fraction (LVEF) ≥ 50% - 6 month prior to drug administration.
- •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
- •Known history or evidence of brain metastases.
- •Require any antineoplastic therapy.
- •History of prior treatment with anti-LAG
- •Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
- •Had any investigational cytotoxic drug within 4 weeks prior to study treatment.
- •Have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment.
- •Major surgery
- •Hypersensitivity reaction to any monoclonal antibody.
- •Has an active known or suspected autoimmune disease.
- •Has a diagnosis of immunodeficiency.
- •Prior tissue or organ allograft or allogeneic bone marrow transplantation.
- •Requires daily supplemental oxygen
- •History of interstitial lung disease.
- •Significant heart disease
- •History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
- •Infection with HIV or hepatitis B or C at screening.
- •Has an active infection.
- •Unable to have blood drawn.
- •Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Prior life-threatening toxicity to anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
- •Woman who are pregnant or breastfeeding.
研究组 & 干预措施
Cohort 1: Nivolumab and Relatlimab
Experimental
480mg/160mg (co-administered)
干预措施: Nivolumab (Drug)
Cohort 1: Nivolumab and Relatlimab
Experimental
480mg/160mg (co-administered)
干预措施: Relatlimab (Drug)
Cohort 2: Nivolumab and Relatlimab
Experimental
480mg/960mg or 480mg/160mg (sequential administration)
干预措施: Nivolumab (Drug)
Cohort 2: Nivolumab and Relatlimab
Experimental
480mg/960mg or 480mg/160mg (sequential administration)
干预措施: Relatlimab (Drug)
Cohort 3: Nivolumab and Relatlimab
Experimental
480mg/480mg (sequential administration)
干预措施: Nivolumab (Drug)
Cohort 3: Nivolumab and Relatlimab
Experimental
480mg/480mg (sequential administration)
干预措施: Relatlimab (Drug)
结局指标
主要结局
Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
时间窗: 4 years
次要结局
- Number of participants experiencing study drug-related toxicities(4 years)
研究者
研究点 (4)
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