jRCT2031220656进行中（未招募）不适用
A Phase 2, Single-Arm, Open-Label Study with Dostarlimab Monotherapy in Participants with Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
GlaxoSmithKline K.K.0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 主要终点
- efficacy of dostarlimab
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer
- •Participant has radiologically and endoscopically evaluable disease.
- •Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment
排除标准
- •Participant has distant metastatic disease.
- •Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer.
- •Participant has any history of interstitial lung disease or pneumonitis
- •Participant has experienced any of the following with prior immunotherapy: any irAE of Grade >-3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barre Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary.
- •Participant has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers.
- •Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- •Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients
结局指标
主要结局
efficacy of dostarlimab
The efficacy of dostarlimab in participants with Stage II/III (locally advanced) dMMR/MSI-H rectal cancer.
次要结局
- efficacy
- safety
- immunogenicity
- PK
研究者
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