CTIS2023-505188-36-00进行中（未招募）1 期
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A - MK-3475-06A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
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
- •Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC., Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy., Has an evaluable baseline tumor sample (newly obtained or archival) for analysis., Has adequately controlled blood pressure (BP) with or without antihypertensive medications., Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to =Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have =Grade 2 neuropathy are eligible.
排除标准
- •Direct invasion into adjacent organs such as the aorta or trachea., History of allogenic tissue/solid organ transplant., Clinically significant cardiovascular disease within 12 months from first dose of study intervention., Participants with known gastrointestinal (GI) malabsorption or any other condition that may affect the absorption of lenvatinib., Has risk for significant GI bleeding., Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization., Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization., Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy., Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration., Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication., Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy., Known active central nervous system (CNS) metastases and/or carcinomatous meningitis, Active autoimmune disease that has required systemic treatment in past 2 years., History of human immunodeficiency virus (HIV) infection., History of Hepatitis B or known active Hepatitis C virus infection.
研究者
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