NCT06640049进行中（未招募）2 期
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 in China
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)
研究概览
简要总结
The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment.
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
- •Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal adenocarcinoma
- •Participant has radiologically and endoscopically evaluable disease
- •Participant has a tumor which can be categorized as dMMR or MSI-H by 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
- •Has a known additional malignancy that progressed or required active treatment within the past 2 years
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years
- •Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3, immune-related severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade [SJS (Stevens-Johnson Syndrome, TEN (Toxic Epidermal Necrolysis), DRESS (Drug rash with eosinophilia and systemic symptoms)], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary
- •Has any history of interstitial lung disease or pneumonitis
- •Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant)
- •Has a history of severe allergic and/or anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients
研究组 & 干预措施
Dostarlimab monotherapy
Experimental
Participants will receive dostarlimab as monotherapy.
干预措施: Dostarlimab (Biological)
结局指标
主要结局
Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)
时间窗: 18 months
cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by Independent central review (ICR) for 12 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 12 months of assessment time, amounting to a total of 18 months.
次要结局
- Serum concentration of Dostarlimab(Up to approximately 77 months)
- Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Immune related Adverse Events (irAEs) and AEs leading to death or discontinuation of study intervention.(Up to approximately 77 months)
- Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR(30 months)
- Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR(42 months)
- Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator(3 years)
- Event Free Survival (EFS) as assessed by Investigator(Up to approximately 77 months)
- Number of Participants with cCR12 as assessed by Investigator(18 Months)
- Number of Participants with cCR24 as assessed by Investigator(30 Months)
- Number of Participants with cCR36 as assessed by Investigator(42 Months)
- Objective Response Rate (ORR) assessed by ICR(Up to 37 Weeks)
- Objective Response Rate (ORR) as assessed by Investigator(Up to 37 Weeks)
- Organ Preservation Rate(Up to 3 years)
- Disease-Specific Survival (DSS)(Up to approximately 77 months)
- Disease-Specific Response at 5 years (DSS5)(Up to 5 years)
- Overall Survival (OS)(Up to approximately 77 months)
- Overall Survival at 5 years (OS5)(Up to 5 years)
- Concentration at the end of infusion (C-EOI) of Dostarlimab(Up to approximately 77 months)
- Trough Concentration (C-trough) of Dostarlimab(Up to approximately 77 months)
- Number of Participants with Anti-Drug Antibodies (ADA) against Dostarlimab(Up to approximately 77 months)
研究者
研究点 (1)
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