CTIS2023-503265-27-00招募中1 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 - 219606
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 710
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Is at least 18 years of age., Has an ECOG- PS of 0 or 1., 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 or pneumonitis. 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 colon cancer., Has a tumor that is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery., 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.
研究者
相似试验
招募中
3 期
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2)Colon CancerJPRN-jRCT2011230016Ishibashi Hideyasu50
进行中（未招募）
1 期
A Study of Relatlimab-nivolumab Fixed-dose Combination versus Regorafenib or TAS-102 in Participants with Later-lines of Metastatic Colorectal CancerMetastatic Colorectal CancerMedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-004285-35-PLBristol-Myers Squibb International Corporation700
招募中
3 期
A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines of Metastatic Colorectal CancerColorectal CancerNL-OMON53835Bristol-Myers Squibb24
招募中
1 期
A Study of Relatlimab-nivolumab Fixed-dose Combination versus Regorafenib or TAS-102 in Participants with Later-lines of Metastatic Colorectal CancerCTIS2023-503797-21-00Bristol Myers Squibb International Corporation683
进行中（未招募）
1 期
A Study of Relatlimab-nivolumab Fixed-dose Combination versus Regorafenib or TAS-102 in Participants with Later-lines of Metastatic Colorectal CancerEUCTR2021-004285-35-ATBristol-Myers Squibb International Corporation700