NCT04098068已完成2 期
Phase 2 Study of MK-3475 (Pembrolizumab) in Patients With Microsatellite Unstable (MSI) Tumors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins3 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年1月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Objective Response Rate (ORR) in Patients With MSI (Microsatellite Unstable)-Negative Solid Tumor Malignancies With a Mutator Phenotype
研究概览
简要总结
This study will be looking at whether MK-3475 (pembrolizumab) is effective (anti-tumor activity) and safe in patients with MSI (Microsatellite Unstable) negative cancer with a mutator phenotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with microsatellite stable tumor and a tumor mutation burden (TMB) level measured at > 20 mutations per megabase pairs (MB)
- •Have measurable disease
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •Adequate organ function as defined by study-specified laboratory tests
- •Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
- •Signed informed consent form
- •Willing and able to comply with study procedures
- •Agree to have a biopsy of their cancer
- •Patients with colon cancer must have received at least two prior cancer therapy regimens.
- •Patients with other cancer types must have received at least one prior cancer therapy
- •Progressive disease
排除标准
- •Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements.
- •Patients who have had chemotherapy or biological cancer therapy within 2 weeks prior to the first dose of study drug
- •Patients who have had radiation within 2 weeks prior to the first dose of study drug
- •Patients who have undergone major surgery within 4 weeks of dosing of investigational agent
- •Patients who have received another investigational product or investigational device within 4 weeks prior to receiving study drug
- •Patients who have received any of the following concomitant therapy: Interleukin-2 (IL-2), interferon, or other non-study immunotherapy regimens, immunosuppressive agents, other investigational therapies or chronic use of systemic corticosteroids within one week prior to first dose of study drug
- •Patients who have received a live vaccine within 4 weeks prior to or after any dose of MK-3475 (exception: inactivated flu vaccines)
- •Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration
- •Patient who have had prior treatment with anti-PD-1 (anti-programmed cell death protein 1), anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies
- •Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus (SLE) autoimmune vasculitis, central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin.
- •Patients who have known history of infection with HIV, hepatitis B, or hepatitis C
- •Patients with evidence of interstitial lung disease
- •Systemically active steroid use
- •Patients on home oxygen
- •Patients with oxygen saturation of <92% on room air by pulse oximetry
- •Pregnant or lactating
- •Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures
- •Patient with known active central nervous system metastases and/or carcinomatous meningitis.
- •Patients with primary brain tumors.
- •Requires any other form of systemic or localized antineoplastic therapy while on study
- •Has any tissue or organ allograft
- •Patients with history of allogeneic hematopoeitic stem cell transplant
研究组 & 干预措施
MSI (Microsatellite Unstable) Negative with Mutator Phenotype
Experimental
干预措施: MK-3475 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) in Patients With MSI (Microsatellite Unstable)-Negative Solid Tumor Malignancies With a Mutator Phenotype
时间窗: 2 years
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.
次要结局
- Overall Survival (OS)(80 months)
- Progression-Free Survival (PFS) in Patients Using RECIST 1.1(Response Evaluation Criteria In Solid Tumors)(24 months)
- Disease Control Rate (DCR)(2 years)
- Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity(28 months)
研究者
研究点 (3)
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