Phase 1 Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Percentage of subjects reporting serious adverse events
研究概览
简要总结
The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines.
- •Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.
- •Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Subjects with life expectancy > 12 weeks.
- •Subjects with Eastern Cooperative Oncology Group (ECOG) performance status 0 -
- •Potential child-bearing female who has agreed with contraception and not breast-feeding. For male who also has agreed with contraception.
- •Subjects who have adequate hematological, renal, hepatic and respiratory functions defined.
- •Must agree to present archival tumor tissues to sponsor or be willing to undergo a pre-treatment biopsy.
- •Histologically or cytologically confirmed locally advanced or metastatic solid tumors.
排除标准
- •Female subjects who are pregnant or breast-feeding.
- •Subjects with uncontrolled and significant inter-current illness.
- •Subjects with known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Subjects who have been previously treated with an anti-programmed death 1 (PD-1), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •Subjects who have been previously treated with Mogamulizumab.
- •Subjects with any prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE.
- •Subjects with a history of severe hypersensitivity reactions to drugs.
- •Subjects who have been received chemotherapies, immunotherapy, biologic or hormonal therapies, another investigational drug, radiation or major surgery for cancer treatment within 28 days or 42 days (for nitrosourea or mitomycin C) prior to Cycle 1 Day
- •Subjects who have known active autoimmune disease or syndrome.
- •Subjects who have active inflammatory bowel disease, irritable bowel disease, celiac disease, or other serious GI chronic conditions associated with diarrhea.
研究组 & 干预措施
Mogamulizumab+Nivolumab
During parts 1 and 2, Mogamulizumab and Nivolumab are administered at appropriate intervals.
Part 1 (Dose Escalation Part) During Cohort 1 to 2, Mogamulizumab and Nivolumab are administered in combination.
Part 2 (Expansion Part) Patients will be treated with maximum tolerated dose established in the dose escalation part for each combination.
干预措施: Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558) (Biological)
结局指标
主要结局
Percentage of subjects reporting serious adverse events
时间窗: From the first dose of study medications until 90 days after the last dose of study medication
Number of subjects reporting serious adverse events
时间窗: From the first dose of study medications until 90 days after the last dose of study medication
Percentage of subjects reporting adverse events
时间窗: From the first dose of study medications until 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicity
时间窗: For 28 days from the first dose of study medications
Number of subjects reporting adverse events
时间窗: From the first dose of study medications until 90 days after the last dose of study medication
次要结局
未报告次要终点