2023-505672-30-00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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 8
- 主要终点
- 1. PFS defined as the time from randomization to the first occurrence of progression as determined by the Investigator according to RECIST v1.1 or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first
研究概览
简要总结
To evaluate the clinical activity of RO7247669 at 600 mg and 1200 mg every 3 weeks (Q3W) on the basis of progression-free survival (PFS)
研究设计
- 分配方式
- Randomized
- 主要目的
- A Study Of Ro7247669 In Participants With Melanoma
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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.
- •Participants must have known PD-L1 status
排除标准
- •Pregnancy, lactation, or breastfeeding
- •Participants must not have ocular melanoma
- •Symptomatic central nervous system (CNS) metastases.
- •Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
- •Active or history of autoimmune disease or immune deficiency with some exceptions
- •Prior systemic anticancer therapy for unresectable or metastatic melanoma
研究组 & 干预措施
RO7247669
Test
干预措施: RO7247669 (Drug)
结局指标
主要结局
1. PFS defined as the time from randomization to the first occurrence of progression as determined by the Investigator according to RECIST v1.1 or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first
1. PFS defined as the time from randomization to the first occurrence of progression as determined by the Investigator according to RECIST v1.1 or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first
次要结局
- 1. Nature, frequency, and severity of AEs graded according to the NCI CTCAE v5.0
- 2. ORR, defined as the proportion of participants with an objective response (i.e., complete response [CR] or partial response [PR]), according to RECIST v1.1
- 3. DCR, defined as ORR + stable disease rate (SDR)
- 4. DoR for participants with objective response, defined as the time from the first occurrence of a documented objective response to disease progression according to RECIST v1.1 or death from any cause, whichever occurs first
- 5. Serum concentrations, PK profiles and parameters for RO7247669
- 6. Incidence and titer of RO7247669 ADAs during the study relative to the prevalence of ADA at baseline
- 7. Relationship between ADA status and PK, safety, pharmacodynamics, and efficacy
- 8. Changes from baseline in the phenotype and activation status of T cell subsets in the peripheral blood (CD4/CD8 HLA-DR+/Ki67+)
- 9. changes from baseline in the tumor microenvironment (such as CD8 T-cell infiltration, proliferation (CD8+Ki67+))
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (8)
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