A Phase II Single-arm, Open-label Monotherapy Clinical Trial of Pembrolizumab (MK-3475) in Locally Advanced/Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-427) - Pembrolizumab in advanced renal cell carcinoma

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 255 人2016年8月30日

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简要总结

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注册库

who.int

开始日期

2016年8月30日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

入排标准

入选标准

•\- Be willing and able to provide written informed consent for the trial
•\- Be \> or \= 18 years of age on day of signing informed consent
•\- Cohort A (clear cell cohort) must have histologically confirmed diagnosis of clear cell RCC or RCC with clear cell component (with or without sarcomatoid features)
•\- Cohort B (non\-clear cell cohort) must have histologically confirmed diagnosis of non\-clear cell RCC (with or without sarcomatoid features) by site pathologist. Cohort B, sites will submit tissues for histologic confirmation of the diagnosis of non\-clear cell RCC by central histology review during the screening phase. Sites should enroll subjects
•in Cohort B after receiving notice that the submitted tissue was adequate for central review. Confirmation of non\-clear cell RCC histology by the central laboratory will be made
•available to the sites as a later date.
•\- Have locally advanced/metastatic disease, i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer (AJCC) or have recurrent disease
•\- Have measurable disease per RECIST 1\.1 as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
•\- Have received no prior systemic therapy for advanced RCC
•Note: Prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed \> 12 months prior to allocation.

排除标准

•\- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to allocation, has had major surgery within 4 weeks or radiation therapy within 2 weeks prior to allocation, or who has not recovered (i.e., \< or \= Grade 1 or at baseline) from adverse events due to prior treatment
•\- Had prior treatment with any anti\-PD\-1, or PD\-L1, or PD\-L2 agent or an antibody targeting any other immune\-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD\-L1, IL\-2R, GITR
•\- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding 10 mg daily dose of prednisone or equivalent or any other form of immunosuppressive therapy within 7 days prior to allocation, except in the case of central nervous system (CNS) metastases
•\- Has an active autoimmune disease requiring systemic treatment within the past 2 years, (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); OR a documented history of clinically severe autoimmune disease
•\- Has a known additional malignancy that has had progression or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, such as breast cancer in situ, that has undergone potentially curative therapy are acceptable
•\- Has known CNS metastases and/or carcinomatous meningitis
•\- Has a history of (non\-infectious) pneumonitis that required steroids or current pneumonitis
•\- Has had a prior solid organ transplant