NCT05855200招募中3 期
A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 892
- 试验地点
- 264
- 主要终点
- Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.
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
盲法说明
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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
- •Has untreated pathologically confirmed colon adenocarcinoma
- •Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
- •Has radiologically evaluable disease
- •Has a tumor demonstrating the presence of either dMMR status or MSI-H
排除标准
- •Has distant metastatic disease.
- •Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer
- •Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible.
- •Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
- •Has any history of interstitial lung disease or pneumonitis and/or history of radiation induced enteritis.
- •Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
- •Has a history of allogenic stem cell transplantation or organ transplantation
- •Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
- •Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
- •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, or any components of FOLFOX or CAPEOX
研究组 & 干预措施
Standard of Care (SOC)
Active Comparator
Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.
干预措施: CAPEOX (Drug)
Dostarlimab
Experimental
Participants will receive Dostarlimab pre and post surgery
干预措施: Dostarlimab (Biological)
Standard of Care (SOC)
Active Comparator
Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.
干预措施: FOLFOX (Drug)
结局指标
主要结局
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
时间窗: Up to approximately 5 years
EFS is defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery
次要结局
- Serum Predose trough concentration (Ctrough) of Dostarlimab(Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days))
- Number of Participants with Pathological Response(Up to approximately 5 years)
- Number of Participants with Anti-Drug Antibodies against Dostarlimab(Up to approximately 5 years)
- Overall Survival (OS)(Up to approximately 5 years)
- Event-free Survival (EFS) assessed by local assessment(Up to approximately 5 years)
- Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment(Up to approximately 5 years)
- Number of Participants with AEs and SAEs by Severity(Up to approximately 5 years)
- Serum Concentration of Dostarlimab(Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days))
- Serum Concentration of Dostarlimab at End of Infusion (C-EoI)(End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days))
研究者
研究点 (264)
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