JPRN-jRCT2051200127进行中（未招募）3 期
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of Care Therapy as First-line Intervention in Participants with Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
Koh Yasuhiro0 个研究点目标入组 120 人开始时间: 2021年1月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
- •-Has had major surgery within 28 days prior to first dose of study interventions
- •-Has had radiotherapy within 14 days of randomization
- •-Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- •-Has known CNS metastases and/or carcinomatous meningitis
- •-Has severe hypersensitivity (>=Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products
- •-Has had an allogeneic tissue/solid organ transplant
- •-Has perforation risks or significant gastrointestinal (GI) bleeding
- •-Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants)
- •-Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- •-Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb
- •-Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
- •-Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- •-Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- •-Has inadequate cardiac function
- •-Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis
- •-Has poorly controlled diarrhea
- •-Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment.
- •-Has peripheral neuropathy >=Grade 2
- •-Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies
- •-Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- •-Has weight loss of >20% within the last 3 months
排除标准
- •Has had previous therapy for locally advanced unresectable or metastatic gastric/GEJ cancer
- •-Has had major surgery within 28 days prior to first dose of study interventions
- •-Has had radiotherapy within 14 days of randomization
- •-Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- •-Has known CNS metastases and/or carcinomatous meningitis
- •-Has severe hypersensitivity (>=Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products
- •-Has had an allogeneic tissue/solid organ transplant
- •-Has perforation risks or significant gastrointestinal (GI) bleeding
- •-Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants)
- •-Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- •-Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb
- •-Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
- •-Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- •-Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- •-Has inadequate cardiac function
- •-Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis
- •-Has poorly controlled diarrhea
- •-Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment.
- •-Has peripheral neuropathy >=Grade 2
- •-Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies
- •-Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- •-Has weight loss of >20% within the last 3 months
研究者
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