A Multicenter, Single-arm, Open-label Phase II Study to Evaluate the Efficacy and Safety of YH003 in Combination with Pebolizumab and Albumin Paclitaxel in First-line Treatment of Patients with Unresectable/metastatic Mucosal Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- Confirmed Objective Response Rate (ORR)
研究概览
简要总结
This study is a multicenter, single-arm, open-label phase II study to assess the efficacy and safety of YH003 in combination with pembrolizumab and nab-paclitaxel in the first-line treatment of patients with unresectable/metastatic mucosal melanoma.
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
- •1.Subjects must have the ability to understand and willingness to sign a written informed consent document.
- •Subjects must have histologically advanced or cytologically confirmed metastatic or unresectable mucosal melanoma;
- •3.Subjects have not received standard systemic therapy; patients have disease progression 6 months or more after the end of neoadjuvant or adjuvant therapy (except nab-paclitaxel), and can be enrolled in the clinical study;
- •Subject must have at least 1 unidimensional measurable disease by RECIST 1.1;
- •Subjects must be age 18 years or older;
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥3 months based on investigator's judgement；
- •Subjects must have adequate organ function;
- •Women of childbearing potential need to have a negative pregnancy test and need to take contraceptive/contraceptive measures including their partners.
排除标准
- •1.Subjects have another active invasive malignancy within 5 years；
- •2.The subject has received anti-tumor therapy or other investigational drug therapy or traditional Chinese medicine (herbal medicine) with anti-tumor indications prior to the first dose;
- •3.Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy.
- •4.History of clinically significant sensitivity or allergy ；
- •5.Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.；
- •6.History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease；
- •7.Subjects have active pulmonary embolism with hemodynamic changes 12 weeks before the first dose;
- •Subjects must not have a known or suspected history of autoimmune disease within 3 years prior to the first dose of study treatment;
- •Subjects have clinically uncontrolled diseases;
- •Subjects have severe cardiovascular disease;
- •Subjects have evidence of active infection;
- •Subjects must not have a known or suspected history of an autoimmune disorder；
- •13.Major surgery within 4 weeks prior to study entry and Minor surgery within 2 weeks prior to the first dose.
- •Any condition that the investigator assesses as inappropriate for participation in the study.
研究组 & 干预措施
Intervention/treatment
YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma
干预措施: YH003 (Drug)
Intervention/treatment
YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma
干预措施: Pembrolizumab (Drug)
Intervention/treatment
YH003 in combination with pebolizumab and albumin paclitaxel in first-line treatment of patients with unresectable/metastatic mucosal melanoma
干预措施: albumin paclitaxel (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (ORR)
时间窗: up to 2 years
Overall Response Rate (ORR) by investigator's assessment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
次要结局
未报告次要终点