NCT05419388已完成2 期
A Randomized, Open-Label, Multicenter, Phase II Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
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
- 93
- 试验地点
- 22
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of two dose levels of RO7247669 in participants with unresectable or metastatic melanoma to select the recommended dose for further development.
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
- •Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV)
- •Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Known v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
- •Adequate cardiovascular, hematological, hepatic and renal function
- •Willingness to abide by contraceptive measures for the duration of the study
- •Participants must have known PD-L1 status
排除标准
- •Pregnancy, lactation, or breastfeeding
- •Known hypersensitivity to any of the components of RO7247669
- •Participants must not have ocular melanoma
- •Symptomatic central nervous system (CNS) metastases
- •Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
- •Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 28 days prior to randomization
- •Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study
- •Active or history of autoimmune disease or immune deficiency with some exceptions
- •Prior systemic anticancer therapy for unresectable or metastatic melanoma
- •Prior anticancer therapy with any-immunomodulatory agents including CPIs (such as anti-programmed death-ligand 1[PD-L1]/PD-1 and anti-cytotoxic T lymphocyte-associated antigen [CTLA-4]) with some exceptions if used as prior adjuvant or neoadjuvant melanoma therapies
- •Prior treatment with anti-LAG3 therapy
研究组 & 干预措施
Low dose every three weeks (Q3W)
Experimental
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
干预措施: RO7247669 (Drug)
High dose Q3W
Experimental
Participants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
干预措施: RO7247669 (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From randomization to the first occurrence of progression or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first (up to 25 months)
次要结局
- Change from baseline in the number and activation status of peripheral blood immune cells(Baseline up to 25 months)
- Percentage of Participants with Adverse Events(Up to 25 months)
- Disease control rate (DCR)(Up to 25 months)
- Serum concentration of RO7247669(Up to 25 months)
- Change from baseline in the number and activation of immune cells in the tumor microenvironment(Baseline to Cycle 2 Day 9 (cycle = 21 days))
- Objective response rate (ORR)(Up to 25 months)
- Duration of response (DOR)(From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 25 months))
- Percentage of participants with anti-drug antibodies (ADAs)(Baseline up to 25 months)
研究者
研究点 (22)
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