NCT05723562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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 154
- 试验地点
- 43
- 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 purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.
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 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 imAE of 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 (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.
- •Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).
研究组 & 干预措施
Dostarlimab monotherapy
Experimental
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 ICR for 12 months following their post-intervention disease assessment (PIDA)
次要结局
- 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 74 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 33 Weeks)
- Objective Response Rate (ORR) as assessed by Investigator(Up to 33 Weeks)
- Organ Preservation Rate(3 years)
- Disease-Specific Survival (DSS)(Up to 74 months)
- Disease-Specific Response at 5 years (DSS5)(Up to 5 years)
- Overall Survival (OS)(Up to 74 months)
- Overall Survival at 5 years (OS5)(Up to 5 years)
- Number of Participants with discontinuation of study intervention(Up to 24 weeks)
- Serum concentration of Dostarlimab(Up to 37 weeks)
- Concentration at the end of infusion (C-EOI) of Dostarlimab(Up to 37 weeks)
- Trough Concentration (C-trough) of Dostarlimab(Up to 37 weeks)
- Number of Participants with Anti-Drug Antibodies against Dostarlimab(Up to 37 weeks)
- 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 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 74 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 33 Weeks)
- Objective Response Rate (ORR) as assessed by Investigator(Up to 33 Weeks)
- Organ Preservation Rate(3 years)
- Disease-Specific Survival (DSS)(Up to 74 months)
- Disease-Specific Response at 5 years (DSS5)(Up to 5 years)
- Overall Survival (OS)(Up to 74 months)
- Overall Survival at 5 years (OS5)(Up to 5 years)
- Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Immune mediated Adverse Events (imAEs) based on Severity(Up to 74 months)
- Number of Participants with discontinuation of study intervention(Up to 24 weeks)
- Serum concentration of Dostarlimab(Up to 37 weeks)
- Concentration at the end of infusion (C-EOI) of Dostarlimab(Up to 37 weeks)
- Trough Concentration (C-trough) of Dostarlimab(Up to 37 weeks)
- Number of Participants with Anti-Drug Antibodies against Dostarlimab(Up to 37 weeks)
研究者
研究点 (43)
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