A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer naive to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A.

Shimoyama Ryo0 个研究点目标入组 120 人开始时间: 2022年7月8日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

•- 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 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.

发起方

Shimoyama Ryo