計劃書編號MK-3475-06B
NCT Number(ClinicalTrials.gov Identfier)NCT05319730
試驗執行中
2022-12-15 - 2027-12-31
Phase I/II
召募中7
ICD-10C15.9
食道惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9150.9
食道惡性腫瘤
一項針對罹患晚期食道癌且先前曾暴露於PD-1／PD-L1治療的受試者，使用研究性藥劑搭配或不搭配Pembrolizumab（MK-3475）和／或化學治療的第1／2期開放標示、傘式平台設計試驗（KEYMAKER-U06）：06B子試驗。
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試驗申請者
美商默沙東藥廠股份有限公司台灣分公司
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試驗委託 / 贊助單位名稱
美商默沙東藥廠股份有限公司台灣分公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
食道鱗狀細胞癌
試驗目的
主要目的：
(1)安全性導入期：評估尚未在另一項試驗中評估的組合治療的安全性和耐受性。
(2)由盲性獨立中央審查委員會（BICR）依據實體腫瘤反應評估標準第1.1版（RECIST 1.1）所評估，估計客觀反應率（ORR）。
次要目的：
(1)療效期：由BICR依據RECIST 1.1所評估，評估無惡化存活期（PFS）。
(2)療效期：由BICR依據RECIST 1.1所評估，評估反應持續時間（DOR）。
(3)療效期：評估整體存活期（OS）。
(4)療效期：根據發生AE的受試者比例，評估研究性治療組合的安全性和耐受性。
藥品名稱
注射劑
膠囊劑
注射劑
注射劑
注射劑
注射劑
膠囊劑
注射劑
注射劑
注射劑
注射劑
主成份
Lenvatinib mesilate
Pembrolizumab (Humanized anti-PD-1 mAb)
Lenvatinib mesilate
Fully human anti-ILT4 IgG4 monoclonal antibody
Paclitaxel
Irinotecan Hydrochloride
Pembrolizumab (Humanized anti-PD-1 mAb)
Lenvatinib mesilate
Fully human anti-ILT4 IgG4 monoclonal antibody
Paclitaxel
Irinotecan Hydrochloride
劑型
capsule
Injection
Capsule
Injection
Injection
Injection
Injection
Capsule
Injection
Injection
Injection
劑量
4 mg/capsule
100 mg/ 4 mL
10 mg/capsule
800 mg/16mL/vial
100mg/16.7mL
100mg/5mL
100 mg/ 4 mL
10 mg/capsule
800 mg/16mL/vial
100mg/16.7mL
100mg/5mL
評估指標
1. 劑量限制毒性(DLT)
2. 不良事件(AE)
3. 因AE造成的試驗停止治療
4. 客觀反應率(ORR)
2. 不良事件(AE)
3. 因AE造成的試驗停止治療
4. 客觀反應率(ORR)
主要納入條件
•經組織學或細胞學確診患有局部晚期無法切除或轉移性的食道鱗狀細胞癌（ESCC）
•經試驗主持人記錄先前接受一線標準療法時的放射影像或臨床疾病惡化，包含鉑劑且先前暴露於以抗程序性細胞死亡蛋白1（PD1）／程序性細胞死亡配體1（PD-L1）為基底的療法
•具有可評估的基期腫瘤檢體（新取得或庫存）進行分析。
•在有或無使用降血壓藥物下血壓（BP）獲得充分控制
•受試者因之前的抗癌治療所造成的不良事件（AE）必須復原至≤第1級或基期。發生內分泌相關AE且接受補充荷爾蒙充分治療的受試者，或患有≤第2級神經病變的受試者符合資格
•經試驗主持人記錄先前接受一線標準療法時的放射影像或臨床疾病惡化，包含鉑劑且先前暴露於以抗程序性細胞死亡蛋白1（PD1）／程序性細胞死亡配體1（PD-L1）為基底的療法
•具有可評估的基期腫瘤檢體（新取得或庫存）進行分析。
•在有或無使用降血壓藥物下血壓（BP）獲得充分控制
•受試者因之前的抗癌治療所造成的不良事件（AE）必須復原至≤第1級或基期。發生內分泌相關AE且接受補充荷爾蒙充分治療的受試者，或患有≤第2級神經病變的受試者符合資格
主要排除條件
Exclusion Criteria:
Direct invasion into adjacent organs such as the aorta or trachea.
Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy.
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
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.
History of allogenic tissue/solid organ transplant.
Clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Known GI malabsorption or any other condition that may affect the absorption of lenvatinib. (Not applicable to actively enrolling arms as of Amendment 5)
Has risk for significant GI bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization. (Not applicable to actively enrolling arms as of Amendment 5)
Direct invasion into adjacent organs such as the aorta or trachea.
Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy.
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
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.
History of allogenic tissue/solid organ transplant.
Clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Known GI malabsorption or any other condition that may affect the absorption of lenvatinib. (Not applicable to actively enrolling arms as of Amendment 5)
Has risk for significant GI bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization. (Not applicable to actively enrolling arms as of Amendment 5)
試驗計畫預計收納受試者人數
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台灣人數
32 人
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全球人數
90 人
