2023-503265-27-00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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 343
- 试验地点
- 116
- 主要终点
- Event Free Survival (EFS) with recurrence assessed by Blinded Independent Central Review (BICR). Where an event is defined as: Disease recurrence based on radiological assessment by BICR; Disease progression precluding surgery (local assessment); Disease recurrence based on a pathological assessment of new lesions identified after surgery (local assessment); Death due to any cause; Treatment related toxicity that results in the participant not being suitable for surgery.
研究概览
简要总结
The Primary objective is to evaluate the efficacy of peri-operative dostarlimab compared with standard of care in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Charter for the Independent data Monitoring Committee (IDMC)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Is at least 18 years of age.
- •Has an ECOG- PS of 0 or
- •Has adequate organ function.
- •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 a dMMR status or MSI-H phenotype.
- •Participants who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) or EPCAM gene may be eligible to participate.
- •Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of colon cancer.
- •Is willing to use adequate contraception.
- •Can provide a signed informed consent.
排除标准
- •Has distant metastatic disease.
- •Is immunocompromised.
- •Has documented presence of HBsAg at Screening or within 3 months prior to randomization.
- •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-mediated 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, TEN, or DRESS syndrome), or myocarditis of any grade.
- •Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment.
- •Has a history of congenital long QT syndrome.
- •Has a history of or evidence of cardiac abnormalities.
- •Is receiving any other anticancer or experimental therapy.
- •Is receiving immunosuppressive medication.
- •Has received systemic corticosteroids (>10 mg daily prednisone or equivalent) within 7 days of first dose of study intervention.
- •Has received any live vaccine within 30 days of enrollment.
- •Has a positive HCV antibody test result at Screening Visit or within 3 months prior to randomization.
- •Has a positive HCV RNA test result at Screening Visit or within 3 months prior to randomisation.
- •Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 9 months after the last dose of study intervention.
- •Has any condition that would exclude the patient from chemotherapy with FOLFOX or CAPEOX.
- •Has any history of interstitial lung disease /pneumonitis and/or 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 or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the study results, interfere with their participation for the full duration of the study intervention, or indicate it is not in the best interest of the participant to participate.
- •Has a history of allogenic stem cell transplantantion or organ transplantation.
- •Has received prior medical therapy, radiation therapy or surgery for management of the current diagnosis of colon cancer.
- •Has a tumor that 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).
- •Has a tumor that is not amenable to surgery or has any other contraindication to surgery.
- •Has a known additional malignancy that progressed or required active treatment within the past 2 years.
结局指标
主要结局
Event Free Survival (EFS) with recurrence assessed by Blinded Independent Central Review (BICR). Where an event is defined as: Disease recurrence based on radiological assessment by BICR; Disease progression precluding surgery (local assessment); Disease recurrence based on a pathological assessment of new lesions identified after surgery (local assessment); Death due to any cause; Treatment related toxicity that results in the participant not being suitable for surgery.
Event Free Survival (EFS) with recurrence assessed by Blinded Independent Central Review (BICR). Where an event is defined as: Disease recurrence based on radiological assessment by BICR; Disease progression precluding surgery (local assessment); Disease recurrence based on a pathological assessment of new lesions identified after surgery (local assessment); Death due to any cause; Treatment related toxicity that results in the participant not being suitable for surgery.
次要结局
- Pathological response determined by local assessment.
- OS, defined as time from randomization to death from any cause.
- EFS with recurrence assessed by local assesment (component events are the same as primary endpoint).
- Frequency and severity of treatment emergent AEs, SAEs, irAEs, and AEs leading to death or discontinuation of study intervention.
- Serum concentrations and relevant PK parameters (C-EoI and Ctrough) for dostarlimab.
- Incidence of ADA against dostarlimab.
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited
研究点 (116)
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